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Completed

NCT Number: NCT03218982

Vietnamese Caregiver Intervention Study

The purpose of this study is to develop and implement a culturally-appropriate intervention to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test the feasibility and acceptability of the intervention in a community setting. This will be done by randomly assigning a family triad (primary caregiver, secondary caregiver, and their care recipient) into an active intervention or a control condition and monitoring findings at baseline, post-intervention, and at three months.The intervention will consist of multiple components -enhanced psycho-education that includes discussion of Alzheimer's Disease (AD) and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitation of support seeking, and mindful Tai Chi. A secondary caregiver who the primary caregiver identifies as providing him/her with the most support will be invited to join all components, but the intervention will be flexible depending on caregivers' needs/preferences. The care recipient is not required to join the sessions but will be able to if he/she or the family wishes. During the intervention, community partners will provide respite care for the care recipient.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

About this study

Twenty-four (24) caregivers, the identified secondary caregiver, and a care recipient will be randomly assigned into the active intervention or a control condition: 16 triads in the intervention condition, 8 in the control.

For the primary caregivers: Primary caregivers will attend six weekly intervention sessions lasting 2 hours each. Based on previous Randomized Controlled Trials (RCTs) of a successful behavior change (i.e., smoking cessation) intervention in Vietnamese using only 2-3 sessions, six sessions were chosen as a middle ground. In the first 45 minutes, primary caregivers and a secondary caregiver (who the primary caregiver identifies) will participate in family psycho-education delivered by a Master's level trained, bilingual facilitator. Each group will consist of no more than four dyads (4 different groups totaling 16 dyads). The curriculum will be adapted based on what the Alzheimer's Association and REACH II have successfully used as well as what the University of California (UC) Davis Alzheimer's Disease Center (ADC) has implemented. The sessions will cover the following: a clinical model of dementia and helping family members come to a shared understanding of the nature and cause of dementia. The innovative component is a discussion of cultural values typical of individuals in Vietnamese and American cultures and how this can influence perceptions of dementia and caregiving strategies. This is important because it will help family members who disagree on the etiology of dementia and strategies for care to empathize with each other's perspective. Subsequent sessions will help caregivers learn skills and develop self-efficacy in dealing with patient symptoms, accessing resources (e.g., in-home support), and gaining family support in culturally-congruent ways. Facilitating the use of formal and informal support is a critical piece as Vietnamese caregivers may be looking for basic and concrete assistance rather than help in coping with caregiving.

The last part of the intervention is mindful Tai Chi that was chosen for several reasons. In a recent review and meta-analysis, Tai Chi showed beneficial effects on depression, anxiety, stress management, and self-efficacy. Second, Tai Chi is rooted in East Asian traditions and philosophies that promote balance and healing of the mind and body, thus addressing holistic beliefs Vietnamese have about wellness. An RCT of Tai Chi recently was successfully completed in Vietnam, demonstrating its growing acceptance in the Vietnamese population. The protocol will be adapted to meet caregivers' needs and highlight meditation that involves accepting stressful circumstances, thus capitalizing on emotion regulation strategies.

For the care recipients: Care recipients will receive the Montreal Cognitive Assessment (MoCA) measure to assess their mental status at baseline. The purpose of the Quality of Life - Alzheimer's Disease (QoL-AD) measure is to assess the caregiver intervention affects the care recipient's quality of life. The total time to complete these questionnaires is about 30 minutes per session.

Participants not randomized to the active intervention will receive educational materials/pamphlets on dementia and occasional phone-calls by research assistants to maintain contact, as is the standard of care in most caregiver intervention studies. Including a control condition will allow for mirroring of the actual larger trial as closely as possible, and also ascertain the feasibility of randomization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caregivers will be included if they (a) are Vietnamese; (b) are age 21+; (c) speak Vietnamese and/or English (d) provide day-to-day, hands on care to a family member with Alzheimer's disease (AD) or cognitive impairment related to AD (e) have at least one family member who will also participate in the intervention; (f) volunteer informed consent; (g) are physically able to participate; and (g) expect to stay in the Sacramento area for the duration of the study
  • Care recipients will be included if they are (a) Vietnamese; (b) are age 21+; (c) have reported Alzheimer's disease (AD) or cognitive impairment related to AD; (d) have at least one caregiver who is participating in the intervention (e) volunteer informed consent or surrogate consent, and (f) expect to stay in the Sacramento area for the duration of the study

Exclusion criteria

  • If the care recipient expresses dissent to participation or to the use of surrogate consent, then he/she will be excluded from the study.

Treatment and study plan

Enhanced psycho-education about dementia and caregiving

Behavioral

Enhanced psycho-education re dementia and caregiving helping family members come to shared understanding of the nature and cause of dementia. Discussion of cultural values in Vietnamese and American cultures and how this can influence perceptions of dementia and caregiving strategies will help family members who disagree on the etiology of dementia and strategies for care to empathize with each other's perspective. Other sessions will teach skills to develop self-efficacy in dealing with patient symptoms, to access resources (e.g., in-home support), and to gain family support in culturally-congruent ways. Mindful Tai Chi is rooted in East Asian traditions and philosophies that promote balance and healing of the mind and body, thus addressing holistic beliefs Vietnamese have about wellness.

Other names: management of problem behaviors, facilitation of support-seeking, mindful Tai Chi

Primary outcomes

  1. Randomization

    Time frame: assessed once all 3-month follow-ups are complete

    % of eligible dyads who agree to randomization

  2. Retention

    Time frame: assessed once all 3-month follow-ups are complete

    Retention in both arms of the study; Note: no formal assessment tool will be used - this will be assessed via number of participants retained

  3. Caregiver Intervention Adherence

    Time frame: assessed at end of study, once all 3-month follow-ups are complete

    % of dyads engaging in the initial session, % completing at least 3 sessions, and % completing all sessions

  4. Treatment Fidelity

    Time frame: assessed once all 3-month follow-ups are complete

    Extent to which the facilitator adheres to the intervention protocol, as measured by a self-report checklist, with a goal of 85% adherence to key elements

  5. Administration of Study Measures

    Time frame: assessed at end of study, once all 3-month follow-ups are complete

    % of baseline, post-, and 3-month assessments completed (considering length of assessments and completeness of collected data

  6. Acceptability

    Time frame: 2 years

    Assessed through a questionnaire and interview assessing the perceptions of the intervention by primary and secondary caregivers, CBO staff/administrators, and interventionists.

Secondary outcomes

  1. Alzheimer's Disease Knowledge Scale (ADKS)

    Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention

    This scale assesses knowledge about AD. The scale has 30 statements. Subjects are asked to rate each statement as True or False.

  2. Caregiver Self-Efficacy

    Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention

    Asks the caregiver about how confident in their ability to keep up their own activities and also respond to caregiving situations. The Scale includes 10 items, and asks caregivers to rate their confidence in handling situations on a scale from 1 to 10.

  3. Center for Epidemiological Studies Depression (CES-D) scale

    Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention

    This is a self-report depression scale that asks how many times during the past week a person has felt symptoms of depression. There are 20 items.

  4. Zarit Burden Inventory (ZBI)

    Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention

    This is a caregiver self-report measure that contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).

  5. Quality of Life - Alzheimer's Disease (QoL-AD)

    Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention

    The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. It was developed for individuals with dementia, based on patient, caregiver, and expert input, to maximize construct validity, and to ensure that the measure focuses on quality of life domains thought to be important in cognitively impaired older adults. It uses simple and straightforward language and responses & includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality.

  6. Perceived Stress Scale

    Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention

    This scale asks subjects about how often they have felt or thought about 10 items during the past month.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Alzheimer's Association
  • National Institute on Aging (NIA)

Registry information

Official study title

A Culturally-Relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2017
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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