NCT04863495

Couples Lived Experience

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 544 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease
• Dementia of Alzheimer Type

Timeline

• Start date: 2021-04-19
• Primary completion: 2026-01-16
• Completion: 2026-01-16
• First posted: 2021-04-28
• Last updated: 2026-02-27

Locations

2 sites across 1 country: United States