Clinical trial NCT04863495: Couples Lived Experience
Official title: A Multi-Center Observational Study of Couples Across the Trajectory of Dementia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Dementia of Alzheimer Type
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-28
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All genders, over the age of 65 that are community dwelling and in a committed relationship with an individual (also over the age of 65) that also agrees to participate in the study

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Score on Geriatric Depression Scale (GDS-15)
timeFrame: Day 0
measure: Score on Geriatric Depression Scale (GDS-15)
timeFrame: Month 6
measure: Score on Geriatric Depression Scale (GDS-15)
timeFrame: Month 12
measure: Score on Geriatric Depression Scale (GDS-15)
timeFrame: Month 18
measure: Score on Geriatric Depression Scale (GDS-15)
timeFrame: Month 24
measure: Score on Geriatric Depression Scale (GDS-15)
timeFrame: Month 30
measure: Score on Geriatric Depression Scale (GDS-15)
timeFrame: Month 36
measure: Score on Beck Anxiety Inventory (BAI) Report
timeFrame: Day 0
measure: Score on Beck Anxiety Inventory (BAI) Report
timeFrame: Month 6
measure: Score on Beck Anxiety Inventory (BAI) Report
timeFrame: Month 12
measure: Score on Beck Anxiety Inventory (BAI) Report
timeFrame: Month 18
measure: Score on Beck Anxiety Inventory (BAI) Report
timeFrame: Month 24
measure: Score on Beck Anxiety Inventory (BAI) Report
timeFrame: Month 30
measure: Score on Beck Anxiety Inventory (BAI) Report
timeFrame: Month 36
measure: Score on Physical Health Questionnaire
timeFrame: Day 0
measure: Score on Physical Health Questionnaire
timeFrame: Month 6
measure: Score on Physical Health Questionnaire
timeFrame: Month 12
measure: Score on Physical Health Questionnaire
timeFrame: Month 18
measure: Score on Physical Health Questionnaire
timeFrame: Month 24
measure: Score on Physical Health Questionnaire
timeFrame: Month 30
measure: Score on Physical Health Questionnaire
timeFrame: Month 36
measure: Score on EuroQol Questionnaire Global quality of life
timeFrame: Day 0
measure: Score on EuroQol Questionnaire Global quality of life
timeFrame: Month 6
measure: Score on EuroQol Questionnaire Global quality of life
timeFrame: Month 12
measure: Score on EuroQol Questionnaire Global quality of life
timeFrame: Month 18
measure: Score on EuroQol Questionnaire Global quality of life
timeFrame: Month 24
measure: Score on EuroQol Questionnaire Global quality of life
timeFrame: Month 30
measure: Score on EuroQol Questionnaire Global quality of life
timeFrame: Month 36
measure: Number of participants with status change
timeFrame: Month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Boston University
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mary Mittelman, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittelman MS, O'Connor MK, Donley T, Epstein-Smith C, Nguyen A, Nicholson R, Salant R, Shirk SD, Stevenson E. Longitudinal study: understanding the lived experience of couples across the trajectory of dementia. BMC Geriatr. 2021 Oct 15;21(1):558. doi: 10.1186/s12877-021-02503-4.