Couples Lived Experience

Alzheimer Disease Clinical Trial

Official title:

A Multi-Center Observational Study of Couples Across the Trajectory of Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863495
• Other study ID #: 19-01966
• Status: Recruiting
• Start date: April 19, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Rebecca Salant
• Phone: 646-754-2249
• Email: Rebecca.salant[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia of Alzheimer Type

Locations

Country	Name	City	State
United States	Boston University	Bedford	Massachusetts
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Geriatric Depression Scale (GDS-15)	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.	Day 0
Primary	Score on Geriatric Depression Scale (GDS-15)	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.	Month 6
Primary	Score on Geriatric Depression Scale (GDS-15)	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.	Month 12
Primary	Score on Geriatric Depression Scale (GDS-15)	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.	Month 18
Primary	Score on Geriatric Depression Scale (GDS-15)	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.	Month 24
Primary	Score on Geriatric Depression Scale (GDS-15)	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.	Month 30
Primary	Score on Geriatric Depression Scale (GDS-15)	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.	Month 36
Primary	Score on Beck Anxiety Inventory (BAI) Report	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.	Day 0
Primary	Score on Beck Anxiety Inventory (BAI) Report	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.	Month 6
Primary	Score on Beck Anxiety Inventory (BAI) Report	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.	Month 12
Primary	Score on Beck Anxiety Inventory (BAI) Report	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.	Month 18
Primary	Score on Beck Anxiety Inventory (BAI) Report	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.	Month 24
Primary	Score on Beck Anxiety Inventory (BAI) Report	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.	Month 30
Primary	Score on Beck Anxiety Inventory (BAI) Report	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.	Month 36
Primary	Score on Physical Health Questionnaire	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).	Day 0
Primary	Score on Physical Health Questionnaire	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).	Month 6
Primary	Score on Physical Health Questionnaire	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).	Month 12
Primary	Score on Physical Health Questionnaire	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).	Month 18
Primary	Score on Physical Health Questionnaire	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).	Month 24
Primary	Score on Physical Health Questionnaire	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).	Month 30
Primary	Score on Physical Health Questionnaire	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).	Month 36
Primary	Score on EuroQol Questionnaire Global quality of life	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"	Day 0
Primary	Score on EuroQol Questionnaire Global quality of life	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"	Month 6
Primary	Score on EuroQol Questionnaire Global quality of life	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"	Month 12
Primary	Score on EuroQol Questionnaire Global quality of life	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"	Month 18
Primary	Score on EuroQol Questionnaire Global quality of life	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"	Month 24
Primary	Score on EuroQol Questionnaire Global quality of life	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"	Month 30
Primary	Score on EuroQol Questionnaire Global quality of life	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"	Month 36
Primary	Number of participants with status change	Status changes include but are not limited to residential care placement, move to live with another relative, death	Month 36