Families Coping Together With Alzheimer's Disease (FACT-AD)

Two remote phone/zoom calls are required to assess experiences as a family coping with dementia.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia; Family Research

Detailed Description

Using a combination of paper or online surveys in addition to interactive visits with blood pressure monitoring, participants are observed interacting with each other. Blood pressure devices are mailed to their homes and only worn for six minute intervals. The first visit generally lasts one hour and the second visit 90 minutes.

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In this study, adult children of a parent over 55 with early stage dementia who are responsible for helping parent with at least one task will be recruited

Description

Inclusion Criteria:

• Parent must be 55 plus with symptoms or a diagnosis of dementia
• Adult child must be over 18 and involved in some way with assisting parent.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
dyad; parent with dementia and an adult child who is a caregiver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver demand appraisals	(1a) Caregiver demand appraisals: 6 items from the 12-item Zarit Burden Interview (ZBI) will assess caregiver appraisals of demands (e.g., That because of the time you spend with your relative that you don't have enough time for yourself?". Caregivers self-report aspects of burden on a scale from 0 (never) to 4 (nearly always; α= .86). Higher numbers indicate higher demands. Administration is 2.5 minutes	Baseline and one year
Caregiver perceived stress	(1b) Caregiver perceived stress: 6 items from the 12-item Zarit Burden Interview (ZBI) will assess caregiver perceived stress (e.g., "Stressed between caring for your relative and trying to meet other responsibilities (work/family)?"). Caregivers self-report aspects of burden on a scale from 0 (never) to 4 (nearly always; α= .86). Higher numbers indicate higher stress. Administration is 2.5 minutes.	Baseline and one year later
Caregiver negative Coping	The Brief COPE Inventory is a shortened version (28 items) of the COPE inventory in which respondents indicate how often they use a particular coping strategy under stress as ranked on a 4-point scale with 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). Examples of items include "I've been using alcohol or drugs to help me get through it." and "I've been criticizing myself" (α=0.72, 0.84, 0.75 for emotion, problem, and dysfunction focused subscales). Higher scores indicate poorer coping. Administration is 10 minutes	Baseline and one year later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relational Functioning	The Relationships Inventory will measure the degree to which individuals perceive that they can rely on their parent or child for help and support when needed (e.g., "to what extent can you count on your parent/child for help with a problem?" "to what extent can you count on your parent/child to give you honest feedback, even when you might not want to hear it?"). Ratings will be made on a scale from 1 (not at all) to 5 (very much; α=.79). Four additional items will assess the degree to which individuals perceive that their parent/child is a good support-provider (e.g., "overall, my parent/child is a good support-provider" using a scale from 1 (strongly disagree) to 7 (strongly agree). Higher numbers indicate higher relationship functioning. Administration is 5 minutes.	Baseline and one year later
Health	Health-related quality of life will be assessed using the 12-item Short Form Survey (SF-12) version 1.0, documenting the extent of limitations in a number of domains. Higher scores indicate better physical and mental health-related quality of life. It has been used with both persons with ADRD and caregivers. Administration is 5 minutes. The minimum and maximum scores are 0 and 100.	Baseline and one year later

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA); Department of Health and Human Services
• Investigators: Principal Investigator: Joan Monin, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2000024219; R01AG058565 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No