NCT04863495Completed
Couples Lived Experience
A Multi-Center Observational Study of Couples Across the Trajectory of Dementia
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 544 (actual)
- First submitted
- 26 Apr 2021
- Start date
- 19 Apr 2021
- Primary completion date
- 16 Jan 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Alzheimer disease
- NCT number
- NCT04863495
What you commit to
- Study type: Observational
- Participants enrolled: 544
- From 19 Apr 2021 to the primary completion date, 16 Jan 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any individual with a prior diagnosis of schizophrenia or other psychotic disorder.
- 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.
Other
- Individual is unable to complete the informed consent process
Who the study is looking for
- Community dwelling older adult aged 65 years or older
- Must speak English as the study measures are not validated in other languages.
- Must express intent to commit to ongoing participation in longitudinal study with assessments every 6 months for 3 years,
- 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
- Both members of the couple must cohabitate at the time of enrollment.
- Must have stable internet connection and capability to stream video with audio.
- 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.
Criteria the registry did not label
- Longitudinal Portion
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston University Coordinator of this site? Confirm its status | Bedford | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.