Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home (CISPAD)
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| ClinicalTrials.gov Identifier: NCT03594851 |
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Recruitment Status :
Completed
First Posted : July 20, 2018
Last Update Posted : August 21, 2019
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Sleep disorder is often a complaint from the older people. Prevalence of sleep disorder increases with aging and reaches between 20 to 45% of the people of 65 years old and more. Sleep physiologically changes with aging. Sleep can also be disturbed by other factors such as intercurrent or related chronic pathologies, environmental change (institutionalized, death of a spouse…), or some medical treatments. Regardless of interindividual variabilities, normative criteria have been defined by a meta-analysis: insomnia can be diagnosed if night wakings are more than 60min and/or if sleep latency is more than 30 minutes.
Various studies have proved the major role of sleep on health and wellbeing. Sleep disorders have an impact on the quality of perception of health and on the quality of life of people and their spouse. According to the French High Health Authority recommendations, sleep diary and validated scales are the tools to use to investigate sleep disorders.
Results from previous studies brought us to consider sleep complaint more specifically and adjust to the heterogeneous population of the investigator's hospital with a subjective approach. This work intends to offer a program of individualized advice to older patients with no cognitive impairment, or with a mild or moderate cognitive impairment, who complain about their sleep quality. Patients with a moderate cognitive impairment who have a caregiver at home can also join the study. The main objective of the study is to evaluate the impact of individualized care for sleep disorders on quality of sleep using the Pittsburgh Sleep Quality Index which validity was demonstrated among the elderly.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Disorder Complaint, Subjective Health | Behavioral: Pittsburgh Sleep Quality Index Behavioral: Sleep diary Behavioral: Katz Index of Independence in Activities of Daily Living Behavioral: Lawton Instrumental Activities of Daily Living Behavioral: Neuropsychiatric Inventory (Cummings) Behavioral: Mini Zarit Caregiver Burden Scale, for the caregiver Behavioral: Mini Mental state examination Behavioral: Cornell Scale for Depression in Dementia Behavioral: Quality of Life in Alzheimer's Disease | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 45 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Administration of individualized advice to older people living at home complaining of sleep disorders |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home Prospective, Monocentric and Open Study |
| Actual Study Start Date : | January 8, 2018 |
| Actual Primary Completion Date : | July 8, 2019 |
| Actual Study Completion Date : | July 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Administration of individualized advice
Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living & Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory |
Behavioral: Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
Other Name: PSQI Behavioral: Sleep diary A sleep diary is a record of a patient's sleep patterns and habits that can be extremely useful in helping doctors make a diagnosis of a sleep disorder and better determine if a sleep study should be prescribed. Behavioral: Katz Index of Independence in Activities of Daily Living Katz Activities of Daily Living is a validated tool to assess functional status as a measurement of the elder's ability to perform activities of daily living independently. Elders are scored yes/no for independence in each of six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less implies severe functional impairment.
Other Name: Katz ADL Behavioral: Lawton Instrumental Activities of Daily Living Lawton's Instrumental Activities of Daily Living (IADL) scale was developed to assess more complex activities (termed "instrumental activities of daily living") necessary for functioning in community settings (e.g., shopping, cooking, managing finances). The capacity to handle these complex functions normally is lost before basic "activities of daily living" which are measured by Activities of Daily Living scales. Therefore, assessing Instrumental Activities of Daily Living may identify incipient decline in older adults who are otherwise capable and healthy.The Lawton Instrumental Activities of Daily Living scale takes approximately 10 to 15 minutes to administer. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). This scale can be administered through an interview or by a written questionnaire. The patient or a caregiver who is familiar with the patient can provide the answers.
Other Name: IADL Behavioral: Neuropsychiatric Inventory (Cummings) Neuropsychiatric Inventory is submitted to the caregiver, if the patient has a Mini Mental State Examination score between 10 and 20. The Neuropsychiatric Inventory (NPI) was developed by Cummings et al. (1994) to assess dementia-related behavioral symptoms which they felt other measures did not sufficiently address. The NPI originally examined 10 sub-domains of behavioral functioning: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity. Two more sub-domains have been added since its development: night-time behavioral disturbances and appetite and eating abnormalities (Cummings, 1997). This wide variety of domains means that, unlike other dementia measures, the NPI is able to screen for multiple types of dementia, not just Alzheimer's Disease. Other Name: NPI Behavioral: Mini Zarit Caregiver Burden Scale, for the caregiver Mini Zarit Caregiver Burden Scale, for the caregiver, if the patient has a Mini Mental State Examination score between 10 and 20. Behavioral: Mini Mental state examination It is an 11-question tool to evaluate cognitive functions. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The Mini Mental state examination takes only 5-10 minutes to administer and is therefore practical to use repeatedly and routinely. The MMSE has been validated and extensively used in both clinical practice and research, since its creation in 1975 Other Name: MMSE Behavioral: Cornell Scale for Depression in Dementia The Cornell scale For Depression in Dementia is a scoring system specifically developed to assess signs and symptoms of major depression in patients with dementia. The 19 parameters measured are clustered into five groups: mood-related signs, behavioural disturbances, physical signs, cyclic functions and ideational disturbances. The Cornell scale For Depression in Dementia has been shown to be sensitive, reliable and valid for assessing depression in patients with Alzheimer's disease. Behavioral: Quality of Life in Alzheimer's Disease The Quality of Life in Alzheimer's Disease is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. It was developed for individuals with dementia, based on patient, caregiver, and expert input, to maximize construct validity, and to ensure that the measure focuses on quality of life domains thought to be important in cognitively impaired older adults. It uses simple and straightforward language and responses & includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality
Other Name: QOL-AD |
- Evaluation of the benefits of individualized advice administration on sleep quality for the elderly living at home and complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Pittsburgh Sleep Quality Index. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
- Impact of a specific follow-up on quantity of sleep of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Review of the sleep diaries to evaluate the impact on the quantity of sleep
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Mini Mental state examination score : Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the frequency of the patient's falls
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Cornell Scale for Depression in Dementia score : The interviews focus on depressive symptoms and signs occurring during the week preceding the interview. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression; scores above 18 indicate a definite major depression; scores below 6 as a rule are associated with absence of significant depressive symptoms.
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Quality of Life in Alzheimer's Disease questionnaire score : The Quality Of Life - Alzheimer Disease questionnaire is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. Caregivers complete the measure as a questionnaire about their patients' Quality Of Life, while patients complete it in interview format about their own Quality Of Life. The measure consists of 13 items, rated on a four point scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52.
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Instrumental Activities of Daily Living questionnaire scores : The Lawton Instrumental Activities of Daily Living scale takes approximately 10 to 15 minutes to administer. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). This scale can be administered through an interview or by a written questionnaire. The patient or a caregiver who is familiar with the patient can provide the answers.
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Katz Activities of Daily Living scores : Elders are scored yes/no for independence in each of six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less implies severe functional impairment.
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Neuropsychiatric Inventory score. The Neuropsychiatric Inventory uses a structured, caregiver-based interview format to assess 10 behavioral domains (Delusions, Hallucinations, Agitation, Dysphoria, Anxiety, Apathy, Irritability, Euphoria, Disinhibition, and Aberrant motor behavior). Two additional domains (Nighttime behavioral disturbance, and Appetite/weight changes) are often added. The presence of problematic behaviors in each domain is assessed by asking an informant a screening question followed by a series of yes/no questions. The caregiver or surrogate reporter is then asked to rate the frequency of occurrence of that domain of behaviors. The same behaviors are then rated on level of severity (1 = mild, 2 = moderate, 3 = severe). The domain total score is the product of the frequency score multiplied by the severity score for that behavioral domain. A Neuropsychiatric Inventory total score is obtained by summing all the individual domain total scores.
- Impact of a specific follow up on quality of life of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the psychotropic drug consumption (how many and which type)
- Impact of a specific follow up on quality of life of caregivers of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the Quality of Life in Alzheimer's Disease questionnaire score : The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. Caregivers complete the measure as a questionnaire about their patients' Quality Of Life, while patients complete it in interview format about their own Quality Of Life. The measure consists of 13 items, rated on a four point scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52.
- Impact of a specific follow up on the burden of caregivers of elderly complaining about their sleep [ Time Frame: Through study completion, an average of 6 months ]Evolution of the 7 item Zarit Care Burden Interview scale score. Points are assigned to each items as follows : never=0; sometimes=0,5 ; often=1 Total score is the sum of all items, 0-2 : Little or no burden 2-3,5: Mild to moderate burden 3,5-5,5: Moderate to severe burden 5,5-7: Severe burden
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient giving a signed informed consent
- Patient complaining about their sleep
- Patient living at home
- Patient with a Mini Mental State Examination score of 10 or more If the Mini Mental State Examination score is between 10 and 20, caregiver living at home able and willing to be in charge of a sleep calendar
- Patient able to fill in questionnaires
Exclusion Criteria:
- Patient living in a senior living facility
- Patient legally protected
- Patient with a psychotic decompensation
- Patient with a sleep pathology
- Patient with a Lewy body disease at the time of enrollment
- Patient with no health insurance
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): NCT03594851
| France | |
| GHRMSA | |
| Mulhouse, France, 68100 | |
| Principal Investigator: | Anna Derajinski, MD | Groupe Hospitalier de la Region de Mulhouse et Sud Alsace |
| Responsible Party: | Groupe Hospitalier de la Region de Mulhouse et Sud Alsace |
| ClinicalTrials.gov Identifier: | NCT03594851 |
| Other Study ID Numbers: |
GHR 924 ID RCB 2017-A02815-48 ( Registry Identifier: Agence Nationale de Sécurité du Médicament et des Produits de Santé ) |
| First Posted: | July 20, 2018 Key Record Dates |
| Last Update Posted: | August 21, 2019 |
| Last Verified: | July 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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quality of sleep elderly health education quantity of sleep caregiver's burden |
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Sleep Wake Disorders Nervous System Diseases Neurologic Manifestations Mental Disorders |