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NCT04863495 · ClinicalTrials.gov registry record
Couples Lived Experience
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 544
- Enrollment target
NCT04863495: Completed study, sponsored by NYU Langone Health.
NCT04863495 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 544 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04863495 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 544 participants
- Enrollment target
Study 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.
Primary Outcome
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 comprehens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2026-01-16 |
What the finished NCT04863495 record still lists
NCT04863495 is an observational study that tracks outcomes without assigning an intervention. The registered 544 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04863495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04863495 about?
NCT04863495 is a clinical study titled "Couples Lived Experience". 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 willin...
What is the current status of trial NCT04863495?
This trial is currently completed. The enrollment target is 544 participants. The study started on 2021-04-19. Estimated completion is 2026-01-16.
Who is sponsoring clinical trial NCT04863495?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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