TACAD Program for Asian American Family Caregivers of Persons Living With Alzheimer's Disease

NCT05615233 | Completed

• 1 other identifier: STUDY00004376
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Caregiver

Outcome Measures

Primary Outcomes (11)

• Change in Multidimensional Caregiver Strain Index from baseline

  Is a questionnaire that evaluates caregiver's health outcome. Total possible score range is 0-26. Higher score correlates with worse outcome.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Perceived Stress Scale score from baseline

  Measure of individual stress. Possible score range is 0-40 with higher scores indicating higher perceived stress.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Acculturation Stress Scale (ASS) score from baseline

  Score range is 0-36. Higher score correlates with worse outcome (higher stress)

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Social Readjustment Rating Scale (SRRS) score from baseline

  This questionnaire asks about number the of events in the last 12 months. Total score range 0-41 and higher score correlates with higher stress.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Midlife Women's Symptom Index from baseline

  This questionnaire measures physical and psychological symptoms during the last 6 months. It includes 73 questions that can be rated from 0-4. Possible score ranges from 0-292. Higher score correlates with worse outcome.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in EQ-5D-5L scale score from baseline

  This is a generic health status measure by the EuroQol Group to measure quality of daily life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/ depression) with five responses for each dimension (no problem to extreme problems); each digit in the five-digit codes refers to the status of each dimension, ranging from 1 (no problem) to 5 (severe problem). Possible score ranges from 0 to 100. A higher score in the EQ-5D-5L indicated better health-related Quality of Life.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score from baseline

  This questionnaire measures the cognitive status of care recipients. Total possible score ranges from 8-40. Higher score correlates with worse outcome.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Lawton ADL/IADL Scale score from baseline

  This questionnaires measures instrumental activities of daily living. The Lawton IADL scale contains eight items, with a summary score from 0 (low function) to 8 (high function). Possible total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. The higher the score, the greater the person's abilities.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Revised Memory and Behavior Problem Checklist score from baseline

  This outcome measures behavioral and psychological symptoms of care recipients. Total possible score ranges between 0-96 with higher score correlating with worse outcome.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Neuropsychological Inventory Questionnaire score from baseline

  This questionnaire measures care recipients' mood status. This is a 12-item inventory assessing severity of mood states or behaviors reflecting mood. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). Total possible score ranges 0 to 144.

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Quality of Life Scale in Alzheimer's Disease score from baseline

  This questionnaire assesses quality of life (QOL) in 13 domains on a one 4-point Likert scale. It is used as a self-report and surrogate-report instrument. It uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks. Total possible score ranges 13 to 52.

  Baseline, 1 months post intervention, 3 months post intervention

Secondary Outcomes (4)

• Change in Caregiver Activity Survey score from baseline

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Ways of Coping Scale score from baseline

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Pearlin Mastery, Loss, and Competence Scale score from baseline

  Baseline, 1 months post intervention, 3 months post intervention

• Change in Caregiver Assessment of Behavioral Skill Scale score from baseline

  Baseline, 1 months post intervention, 3 months post intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patient will use TACAD and the Alzheimer's Association Website

Behavioral: TACAD; Behavioral: Alzheimer's Association website

Active Control Group

ACTIVE COMPARATOR

Patient will use only the Alzheimer's Association Website

Behavioral: Alzheimer's Association website

Interventions

TACAD BEHAVIORAL

Technology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of PLAD (TACAD). It includes four components in three languages (English, MandarinChinese, and Korean): 1. 2 sub-ethnic specific social media sites; 2. interactive online educational modules; 3. online resources; and 4. a VR component based on "A Walk Through Dementia (WTD)"

Intervention Group

Alzheimer's Association website BEHAVIORAL

The webpage on caregiving includes information on caregiving, care option, financial/legal planning, caregiver health, daily care, stages and behaviors, and safety. The content will be available in the three languages at the project website.

Also known as: AA website

Active Control Group; Intervention Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Eun-Ok Im, PhD, MPH

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: April 5, 2024
• Primary Completion: May 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: The availability of the data will be announced on the project website of the proposed study.
• Access Criteria: Applicants must request permission to conduct secondary analyses of the data from the PIs of the proposed study by e-mail or regular mail and provide the PIs with a 1-page long abstract of the proposed analysis and her/his CV. The researcher will be requested to: (a) agree that she/he will provide the findings from her/his analyses to the PIs at the completion of the analyses, (b) acknowledge the original study and the NIH in her/his future publications, and (c) not use the findings from the data for any commercial purposes. This agreement will be made in a written form. The data will be provided to the researcher as a password-protected zipped file that needs to be downloaded through The University of Texas at Austin One Drive cloud service. The password for One Drive link and the password for the zipped file will be sent in separate e-mails.

Locations

US (1)