Couples Lived Experience

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04863495
Collaborator
National Institute on Aging (NIA) (NIH)
600
2
51.4
300
5.8

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Apr 19, 2021
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    Aug 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Score on Geriatric Depression Scale (GDS-15) [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) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Month 36]

      Status changes include but are not limited to residential care placement, move to live with another relative, death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston University Bedford Massachusetts United States 01730
    2 NYU Langone Health New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Mary Mittelman, DrPH, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT04863495
    Other Study ID Numbers:
    • 19-01966
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 25, 2022