Families Coping Together With Alzheimer's Disease

Dementia Clinical Trial

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Official title:

Families Coping Together With Alzheimer's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04642885
• Other study ID #: 2000024219
• Secondary ID: R01AG058565
• Status: Active, not recruiting
• Start date: June 30, 2019
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: November 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Family Research

Locations

Country	Name	City	State
United States	Yale school of Public Health	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	Department of Health and Human Services, National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; a= .86). Higher numbers indicate higher demands. Administration is 2.5 minutes	Baseline and one year
Primary	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; a= .86). Higher numbers indicate higher stress. Administration is 2.5 minutes.	Baseline and one year later
Primary	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" (a=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	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; a=.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
Secondary	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