Clinical trial NCT05615233: TACAD Program for Asian American Family Caregivers of Persons Living With Alzheimer's Disease
Official title: To Reduce the Burden of Caregiving on Health Outcomes of Midlife Women: Asian American Family Caregivers of Persons Living With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Caregiver
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the proposed study is to preliminarily evaluate Technology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of patients living with Alzheimer's disease (TACAD) in improving health outcomes of Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA) and their care recipients.

Detailed description: The purpose of the proposed study is to preliminarily evaluate a technology-based program in improving health outcomes of Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA) and their care recipients.

The participants of this randomized clinical trial will be 60 self-reported AACA aged 40 to 65 years old who identify as Chinese or Korean; are family caregivers of People Living with Alzheimer Disease (PLAD); can read and write English, Mandarin Chinese or Korean; who reside in the U.S.; and have access to the Internet through computers or mobile devices. Participants will be recruited through both online and offline communities/groups for Asian Americans. The recruitment settings are identified through both Internet searches and recommendations by research team members. When potential participants of Phase 2 visit the project Web site (after receiving/reviewing a study announcement), they will be asked to review the informed consent. When participants click I agree to participate, they will have given their consent. No identity information, including IP addresses, will be attached to any of the individual or group data. Therefore, research participants will not be identifiable directly or through the identifying information linked to subjects. Only research staff will have access to the data. Phase 2 study consists of two groups of research participants: (a) a control group who does not use the technology-based program, but uses the information on Alzheimer's Disease and caregiving by the Alzheimer's Association website; (b) an intervention group who uses the technology-based program and the information by the Alzheimer's Association website. Both groups will participate in the study for 3 months. During the research process, both groups are asked to fill out the Internet survey questionnaire (through the REDCap system) at three times (pre-test, post-1 moth, and post 3-months); if requested, paper-and-pencil questionnaires will be provided/used, or research staff will assist in administering the Internet surveys over the phone. Data will be collected only through the Internet survey, and each survey takes about 20 to 30 minutes to complete. Only for the intervention group, weekly group and individual coaching/support (max 1hr/week) by culturally matched bilingual interventionists will be provided through the online forum and chatting functions on the project website, phone calls, or text messages through ethnic-specific communication apps, and the participants are asked to use the educational modules, virtual reality app, and online resources that are available on the project website. The data collected through the Internet surveys will be stored on the HIPAA compliant clouds maintained by The University of Texas at Austin. All documentation related to the study will be also stored on the HIPAA compliant clouds maintained by The University of Texas at Austin.

Eligibility criteria: Inclusion Criteria:

* self reported Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA).
* Participants will be included if, by self-report, they are Asian American women aged 40 to 65 years old who identify as Chinese or Korean;
* are family caregivers of PLAD;
* can read and write English, Mandarin Chinese or Korean;
* who reside in the U.S.;
* have access to the Internet through computers or mobile devices.
* Participants must be providing at least 4 hours per day unpaid assistance, on average, for a community-dwelling person in the early-middle stage of illness (Clinical Dementia Rating of 1) for whom there is no plan for institutionalization in six months.
* Caregivers may or may not reside with their care recipient.

Exclusion Criteria:

* Those who used the AA website previously and/or participated in other studies related to AD will be excluded.

Primary outcomes:
measure: Change in Multidimensional Caregiver Strain Index from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Perceived Stress Scale score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Acculturation Stress Scale (ASS) score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Social Readjustment Rating Scale (SRRS) score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Midlife Women's Symptom Index from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in EQ-5D-5L scale score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Lawton ADL/IADL Scale score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Revised Memory and Behavior Problem Checklist score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Neuropsychological Inventory Questionnaire score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Quality of Life Scale in Alzheimer's Disease score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
Secondary outcomes:
measure: Change in Caregiver Activity Survey score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Ways of Coping Scale score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Pearlin Mastery, Loss, and Competence Scale score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
measure: Change in Caregiver Assessment of Behavioral Skill Scale score from baseline
timeFrame: Baseline, 1 months post intervention, 3 months post intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Eun-Ok Im, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: