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临床试验/NCT03218982
NCT03218982已完成不适用

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

University of California, Davis2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Caregiver Intervention Adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Caregiver Intervention Adherence

时间窗: 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

Administration of Study Measures

时间窗: 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

Acceptability

时间窗: 2 years

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

Treatment Fidelity

时间窗: 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

Randomization

时间窗: assessed once all 3-month follow-ups are complete

% of eligible dyads who agree to randomization

Retention

时间窗: 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

次要结局

  • Zarit Burden Inventory (ZBI)(Baseline, 6-weeks (Post-intervention), 3 months post-intervention)
  • Quality of Life - Alzheimer's Disease (QoL-AD)(Baseline, 6-weeks (Post-intervention), 3 months post-intervention)
  • Center for Epidemiological Studies Depression (CES-D) scale(Baseline, 6-weeks (Post-intervention), 3 months post-intervention)
  • Perceived Stress Scale(Baseline, 6-weeks (Post-intervention), 3 months post-intervention)
  • Caregiver Self-Efficacy(Baseline, 6-weeks (Post-intervention), 3 months post-intervention)
  • Alzheimer's Disease Knowledge Scale (ADKS)(Baseline, 6-weeks (Post-intervention), 3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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