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Insomnia Self-Management in Heart Failure (HSS)

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ClinicalTrials.gov Identifier: NCT02660385
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Yale University

Brief Summary:

Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.

The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined.

A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education.

Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.


Condition or disease Intervention/treatment Phase
Cardiac Failure Heart Failure Congestive Heart Failure Heart Failure, Congestive Sleep Initiation and Maintenance Disorders Chronic Insomnia Disorders of Initiating and Maintaining Sleep Fatigue Pain Depressive Symptoms Sleep Disorders Anxiety Behavioral: Cognitive Behavioral Therapy for Insomnia Behavioral: Self-Management Education for Heart Failure Not Applicable

Detailed Description:

Almost 75% of HF patients, a group of about 5.1 million Americans who have poor function and high levels of morbidity and mortality, report poor sleep. As many as 25-56% of HF patients report chronic insomnia (difficulty initiating or maintaining sleep or waking early in the morning, with non-restorative sleep that persists for at least a month). Chronic insomnia may contribute to the development and exacerbation of HF and incident mortality. It is also associated with common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.However, insomnia is under-diagnosed and under-treated in this population.

Cognitive behavioral therapy for insomnia (CBT-I) is a multi-modal behavioral treatment focused on modifying beliefs and attitudes about sleep and is efficacious in many populations. The purposes of RCT are to evaluate the sustained effects of CBT-I, compared with HF self-management education (attention control), on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia and receive evidence-based HF disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the attention-control condition and explore the effects of CBT-I on event-free survival. We will address the following specific aims (*primary outcomes): (1) Test the sustained effects (baseline - 2 weeks, 6, 9, 12 months) of CBT-I provided in 4 group sessions over 8 weeks, compared with HF self-management education (attention control condition), on: (1a) *insomnia severity and self-reported and actigraph-recorded sleep characteristics (*sleep quality, *sleep efficiency, sleep latency, and duration); (1b) symptoms (*fatigue, anxiety, depression, pain, sleepiness, sleep-related impairment), and psychomotor vigilance (PVT); and (1c) symptom clusters [membership in clusters characterized by severity of specific symptoms; transition between clusters over time]; (2) Test the sustained effects of CBT-I on self-reported and objective functional performance; and (3) Examine the cost-effectiveness of CBT-I. Exploratory aim: We will explore the effects of CBT-I on event-free survival.

A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an attention control condition consisting of HF self-management education. Wrist actigraph measures of sleep, diaries, psychomotor vigilance and 6 minute walk test distance, and self-report measures of insomnia, sleep, symptoms, and functional performance will be obtained at baseline and follow-up. Data analysis will consist of mixed effects models, latent transition analysis, stochastic cost-effectiveness analysis, and survival analysis.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
Study Start Date : October 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
Cognitive behavioral therapy for insomnia (CBT-I) will be provided in a group format, led by an interventionist. CBT-I includes strategies for modifying thoughts and behaviors about sleep. Participants will be instructed on and practice methods for modifying their thoughts and behaviors about sleep and insomnia. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks.
Behavioral: Cognitive Behavioral Therapy for Insomnia
This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.
Other Name: Self-management for insomnia

Active Comparator: Heart Failure Self-Management Education
Heart Failure Self-management education is an intervention that will be provided by a nurse in a group format. This includes standard components, such as education about fluid and sodium management, heart failure medications, diet and physical activity. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks.
Behavioral: Self-Management Education for Heart Failure
This is an educational education designed to teach patients about self-management their heart failure. It includes information on medications, lifestyle, cardiac devices, diet, and when to seek assistance from a health care provider.




Primary Outcome Measures :
  1. Insomnia Severity [ Time Frame: 2 weeks post treatment ]
    Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.

  2. Fatigue [ Time Frame: 2 weeks post treatment ]
    The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.

  3. Sleep Efficiency [ Time Frame: 2 weeks post treatment ]
    Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.


Secondary Outcome Measures :
  1. Sleep duration [ Time Frame: 2 weeks post-treatment ]
    Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

  2. Sleep duration [ Time Frame: 6 months post-treatment ]
    Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

  3. Sleep duration [ Time Frame: 9 months post treatment ]
    Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

  4. Sleep duration [ Time Frame: 12 months post treatment ]
    Sleep efficiency refers the amount of time spent asleep. Sleep duration will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep duration will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

  5. Anxiety [ Time Frame: 2 weeks post intervention ]
    Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.

  6. Anxiety [ Time Frame: 6 months post intervention ]
    Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.

  7. Anxiety [ Time Frame: 9 months post intervention ]
    Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.

  8. Anxiety [ Time Frame: 12 months post iintervention ]
    Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.

  9. Depressive symptoms [ Time Frame: Baseline ]
    Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.

  10. Depressive symptoms [ Time Frame: 2 weeks Post Treatment ]
    Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.

  11. Depressive symptoms [ Time Frame: 6 months post treatment ]
    Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.

  12. Depressive symptoms [ Time Frame: 9 months post treatment ]
    Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.

  13. Depressive symptoms [ Time Frame: 12 months post treatment ]
    Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.

  14. Sleepiness [ Time Frame: Baseline ]
    Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.

  15. Sleepiness [ Time Frame: 2 weeks Post treatment ]
    Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.

  16. Sleepiness [ Time Frame: 6 months post treatment ]
    Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.

  17. Sleepiness [ Time Frame: 9 months post treatment ]
    Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.

  18. Sleepiness [ Time Frame: 12 months post treatment ]
    Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) and the PROMIS Sleep-Related Impairment scales. The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness. The PROMIS Sleep-Related Impairment item bank is a brief self-report instrument that measures perceptions of alertness, sleepiness, and tiredness during usual waking hours. PROMIS instruments are scored using item-level calibrations, with higher scores indicating more sleep-related impairment.

  19. Dyspnea [ Time Frame: Baseline ]
    Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.

  20. Dyspnea [ Time Frame: 2 weeks Post intervention ]
    Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.

  21. Dyspnea [ Time Frame: 6 months post treatment ]
    Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.

  22. Dyspnea [ Time Frame: 9 months post treatment ]
    Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.

  23. Dyspnea [ Time Frame: 12 months post treatment ]
    Symptoms of dyspnea will be measured with the Multidimensional Assessment of Dyspnea Scale, a 16 item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living.

  24. Psychomotor vigilance [ Time Frame: Baseline ]
    Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.

  25. Psychomotor vigilance [ Time Frame: 2 weeks Post treatment ]
    Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.

  26. Psychomotor vigilance [ Time Frame: 6 months post treatment ]
    Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.

  27. Psychomotor vigilance [ Time Frame: 9 months post treatment ]
    Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.

  28. Psychomotor vigilance [ Time Frame: 12 months post treatment ]
    Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.

  29. Functional performance [ Time Frame: Baseline ]
    Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.

  30. Functional performance [ Time Frame: 2 weeks Post treatment ]
    Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.

  31. Functional performance [ Time Frame: 6 months post treatment ]
    Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.

  32. Functional performance [ Time Frame: 9 months post treatment ]
    Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.

  33. Functional performance [ Time Frame: 12 months post treatment ]
    Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.

  34. Functional capacity [ Time Frame: Baseline ]
    Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.

  35. Functional capacity [ Time Frame: 2 weeks Post treatment ]
    Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.

  36. Functional capacity [ Time Frame: 6 months post treatment ]
    Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.

  37. Functional capacity [ Time Frame: 9 months post treatment ]
    Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.

  38. Functional capacity [ Time Frame: 12 months post treatment ]
    Functional capacity will be objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.

  39. Cost effectiveness [ Time Frame: Baseline ]
    Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.

  40. Cost effectiveness [ Time Frame: 2 months post treatment ]
    Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.

  41. Cost effectiveness [ Time Frame: 6 months post treatment ]
    Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.

  42. Cost effectiveness [ Time Frame: 9 months post treatment ]
    Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.

  43. Cost effectiveness [ Time Frame: 12 months post treatment ]
    Cost effectiveness will be evaluated in terms of direct costs for health care resources used [office and emergency department visits, homecare, hospitalizations (and reasons, e.g., HF), cardiac devices, over the counter (OTC) and prescribed medications], as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Information on costs will be obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule. A sub-set of the team, blinded to group assignment, will review hospitalization/ED/office visits and evaluate causes. Effectiveness will be measured as quality adjusted life years (QALY), and research-related costs (monitoring, data collection, personnel costs, and subject payments) will also be tracked.

  44. Event-free survival [ Time Frame: 1 year post treatment ]
    Event free survival will be measured as the absence of death (all cause), heart failure hospitalizations, heart failure emergency department visits, heart transplantation, or artificial heart (LVAD) until the end of the study period. Events will be assessed events through participant/family report and confirmed with the electronic medical record; a sub-set of the team blinded to group assignment will review data to determine cause of death/hospitalization. The National Death Index will be queried if information is otherwise unavailable.

  45. Insomnia Severity [ Time Frame: Baseline ]
    Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.

  46. Insomnia Severity [ Time Frame: 6 months post treatment ]
    Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.

  47. Insomnia Severity [ Time Frame: 9 months post treatment ]
    Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.

  48. Insomnia Severity [ Time Frame: 12 months post treatment ]
    Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.

  49. Fatigue [ Time Frame: Baseline ]
    The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.

  50. Fatigue [ Time Frame: 6 months post treatment ]
    The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.

  51. Fatigue [ Time Frame: 9 months post treatment ]
    The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.

  52. Fatigue [ Time Frame: 12 months post treatment ]
    The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.

  53. Sleep Efficiency [ Time Frame: Baseline ]
    Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

  54. Sleep Efficiency [ Time Frame: 6 months post treatment ]
    Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

  55. Sleep Efficiency [ Time Frame: 9 months post treatment ]
    Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.

  56. Sleep Efficiency [ Time Frame: 12 months post treatment ]
    Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable chronic heart failure, chronic insomnia, English speaking/reading,

Exclusion Criteria:

  • untreated sleep disordered breathing or restless legs syndrome, rotating/night shift work, active illicit drug use, bipolar disorder, neuromuscular conditions affecting the non-dominant arm end-stage renal failure, significant cognitive impairment, unstable medical or psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660385


Contacts
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Contact: Meghan O'Connell, MPH 203-737-3935 meghan.oconnell@yale.edu

Locations
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United States, Connecticut
Yale University School of Nursing Recruiting
West Haven, Connecticut, United States, 06516-7399
Contact: Meghan O'Connell, MPH    203-737-3935    meghan.oconnell@yale.edu   
Sponsors and Collaborators
Yale University
Milton S. Hershey Medical Center
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Nancy S Redeker, PhD Yale University School of Nursing

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02660385     History of Changes
Other Study ID Numbers: 0904005041a
R01NR016191 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yale University:
pain
insomnia
cardiac failure
sleep
fatigue
heart disease
anxiety
actigraphy
psychomotor vigilance
six minute walk
depression
cognitive behavioral therapy
self-management
self-care
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Heart Failure
Disease
Fatigue
Depression
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Behavioral Symptoms