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Couples Lived Experience

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ClinicalTrials.gov Identifier: NCT04863495
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad.

Condition or disease
Alzheimer Disease and Related Dementias (ADRD)

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Observational Study of Couples Across the Trajectory of Dementia
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia




Primary Outcome Measures :
  1. Score on Geriatric Depression Scale (GDS-15) [ Time Frame: Day 0 ]
    This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.

  2. Score on Geriatric Depression Scale (GDS-15) [ Time Frame: Month 6 ]
    This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.

  3. Score on Geriatric Depression Scale (GDS-15) [ Time Frame: Month 12 ]
    This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.

  4. Score on Geriatric Depression Scale (GDS-15) [ Time Frame: Month 18 ]
    This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.

  5. Score on Geriatric Depression Scale (GDS-15) [ Time Frame: Month 24 ]
    This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.

  6. Score on Geriatric Depression Scale (GDS-15) [ Time Frame: Month 30 ]
    This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.

  7. Score on Geriatric Depression Scale (GDS-15) [ Time Frame: Month 36 ]
    This is a 15-item self-report measure of symptoms of depression among older adults. It consists of 15 questions in which participants are asked to respond by answering either 'yes' or 'no' in reference to how they felt over the past week. For each question, dependent on the answer, 1 point is given. Total range of score is 0-15. A score > 5 points is suggestive of depression. A score ≥ 10 points is almost always indicative of depression. A score > 5 points should warrant a follow-up comprehensive assessment.

  8. Score on Beck Anxiety Inventory (BAI) Report [ Time Frame: Day 0 ]
    This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.

  9. Score on Beck Anxiety Inventory (BAI) Report [ Time Frame: Month 6 ]
    This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.

  10. Score on Beck Anxiety Inventory (BAI) Report [ Time Frame: Month 12 ]
    This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.

  11. Score on Beck Anxiety Inventory (BAI) Report [ Time Frame: Month 18 ]
    This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.

  12. Score on Beck Anxiety Inventory (BAI) Report [ Time Frame: Month 24 ]
    This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.

  13. Score on Beck Anxiety Inventory (BAI) Report [ Time Frame: Month 30 ]
    This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.

  14. Score on Beck Anxiety Inventory (BAI) Report [ Time Frame: Month 36 ]
    This is a 21-item self-report measure of symptoms of anxiety, including experiences of physical symptoms associated with anxiety. Participants are asked to rate how each symptom bothered them during the past month, on a 4-point scale from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"). The total range of score is 0-63. The higher the score the higher the severity of symptoms.

  15. Score on Physical Health Questionnaire [ Time Frame: Day 0 ]
    Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).

  16. Score on Physical Health Questionnaire [ Time Frame: Month 6 ]
    Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).

  17. Score on Physical Health Questionnaire [ Time Frame: Month 12 ]
    Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).

  18. Score on Physical Health Questionnaire [ Time Frame: Month 18 ]
    Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).

  19. Score on Physical Health Questionnaire [ Time Frame: Month 24 ]
    Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).

  20. Score on Physical Health Questionnaire [ Time Frame: Month 30 ]
    Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).

  21. Score on Physical Health Questionnaire [ Time Frame: Month 36 ]
    Three questions to assess subjective evaluation of their own health: (1) How would you rate your overall physical health at the present time? (On a 4-point scale from 4 (poor) to 1 (excellent)); (2) Is your health now better, about the same or worse than it was five years ago? (On a 3-point scale; 3 (worse), 2 (about the same), 1 (better)); and (3) How much do your physical health troubles stand in the way of your doing the things you want to do? (On a 3-point scale; 3 (a great deal); 2 (a little (some)); 1 (not at all)). The sum of the 3 questions is used to measure SRH. Possible scores ranged from 3 (least healthy) to 10 (healthiest).

  22. Score on EuroQol Questionnaire Global quality of life [ Time Frame: Day 0 ]
    This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"

  23. Score on EuroQol Questionnaire Global quality of life [ Time Frame: Month 6 ]
    This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"

  24. Score on EuroQol Questionnaire Global quality of life [ Time Frame: Month 12 ]
    This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"

  25. Score on EuroQol Questionnaire Global quality of life [ Time Frame: Month 18 ]
    This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"

  26. Score on EuroQol Questionnaire Global quality of life [ Time Frame: Month 24 ]
    This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"

  27. Score on EuroQol Questionnaire Global quality of life [ Time Frame: Month 30 ]
    This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"

  28. Score on EuroQol Questionnaire Global quality of life [ Time Frame: Month 36 ]
    This scale assesses the respondent's overall quality of life. The respondent is asked to rate how good or bad his overall quality of life is on the day of administration on a scale of 0-100 with 100 being "best imaginable quality of life" and 0 being the "worst imaginable quality of life"

  29. Number of participants with status change [ Time Frame: Month 36 ]
    Status changes include but are not limited to residential care placement, move to live with another relative, death



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:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All genders, over the age of 65 that are community dwelling and in a committed relationship with an individual (also over the age of 65) that also agrees to participate in the study
Criteria

Longitudinal Portion

Inclusion Criteria:

  1. Community dwelling older adult aged 65 years or older
  2. Must speak English as the study measures are not validated in other languages.
  3. Must express intent to commit to ongoing participation in longitudinal study with assessments every 6 months for 3 years,
  4. Is part of a couple and their spouse/partner is also willing to participate in the project. All couples, regardless of sexual orientation or gender preference are eligible to participate
  5. Both members of the couple must cohabitate at the time of enrollment.
  6. Must have stable internet connection and capability to stream video with audio.
  7. A subset of the longitudinal study participants (selected at random) will be invited to be participate in a focus group upon completion of the last (3 year) quantitative assessment. These participants must be willing to have their comments recorded.
  8. Must live in the NYC or Boston metropolitan areas

Exclusion Criteria:

  1. Any individual with a prior diagnosis of schizophrenia or other psychotic disorder.
  2. Individual is unable to complete the informed consent process
  3. Any individual with a prior diagnosis of a chronic disabling medical condition that would make it impossible to participate in a focus group via Zoom or WebEx.

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): NCT04863495


Contacts
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Contact: Rebecca Salant 646-754-2249 Rebecca.salant@nyulangone.org
Contact: Andrew Nguyen 617-358-6437 andrewhn@bu.edu

Locations
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United States, Massachusetts
Boston University Not yet recruiting
Bedford, Massachusetts, United States, 01730
Contact: Andrew Nguyen       andrewhn@bu.edu   
Principal Investigator: Maureen O'Connor, PsyD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Rebecca Salant       Rebecca.salant@nyulangone.org   
Principal Investigator: Mary Mittelman, DrPH         
Sponsors and Collaborators
NYU Langone Health
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Mary Mittelman, DrPH NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04863495    
Other Study ID Numbers: 19-01966
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Mary.Mittelman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders