- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03218982
Vietnamese Caregiver Intervention Study
A Culturally-Relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- University of California, Davis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Intervention
Six weekly intervention sessions (2 hours, each) that include enhanced psycho-education and discussion of AD and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitation of support seeking, and mindful Tai Chi.
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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:
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No Intervention: Control
Participants 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Randomization
Time Frame: assessed once all 3-month follow-ups are complete
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% of eligible dyads who agree to randomization
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assessed once all 3-month follow-ups are complete
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Retention
Time Frame: assessed once all 3-month follow-ups are complete
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Retention in both arms of the study; Note: no formal assessment tool will be used - this will be assessed via number of participants retained
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assessed once all 3-month follow-ups are complete
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Caregiver Intervention Adherence
Time Frame: assessed at end of study, once all 3-month follow-ups are complete
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% of dyads engaging in the initial session, % completing at least 3 sessions, and % completing all sessions
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assessed at end of study, once all 3-month follow-ups are complete
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Treatment Fidelity
Time Frame: assessed once all 3-month follow-ups are complete
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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
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assessed once all 3-month follow-ups are complete
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Administration of Study Measures
Time Frame: assessed at end of study, once all 3-month follow-ups are complete
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% of baseline, post-, and 3-month assessments completed (considering length of assessments and completeness of collected data
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assessed at end of study, once all 3-month follow-ups are complete
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Acceptability
Time Frame: 2 years
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Assessed through a questionnaire and interview assessing the perceptions of the intervention by primary and secondary caregivers, CBO staff/administrators, and interventionists.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Knowledge Scale (ADKS)
Time Frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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This scale assesses knowledge about AD.
The scale has 30 statements.
Subjects are asked to rate each statement as True or False.
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Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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Caregiver Self-Efficacy
Time Frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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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.
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Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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Center for Epidemiological Studies Depression (CES-D) scale
Time Frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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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.
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Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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Zarit Burden Inventory (ZBI)
Time Frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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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).
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Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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Quality of Life - Alzheimer's Disease (QoL-AD)
Time Frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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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.
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Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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Perceived Stress Scale
Time Frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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This scale asks subjects about how often they have felt or thought about 10 items during the past month.
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Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oanh Meyer, PhD, MAS, University of California, Davis
Publications and helpful links
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
- Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.
- Carpenter BD, Balsis S, Otilingam PG, Hanson PK, Gatz M. The Alzheimer's Disease Knowledge Scale: development and psychometric properties. Gerontologist. 2009 Apr;49(2):236-47. doi: 10.1093/geront/gnp023. Epub 2009 Mar 25.
- Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.
- Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
- Meyer OL, Nguyen KH, Dao TN, Vu P, Arean P, Hinton L. The Sociocultural Context of Caregiving Experiences for Vietnamese Dementia Family Caregivers. Asian Am J Psychol. 2015 Sep;6(3):263-272. doi: 10.1037/aap0000024. Epub 2015 Jun 15.
- Resnick B, Ory MG, Hora K, Rogers ME, Page P, Bolin JN, Lyle RM, Sipe C, Chodzko-Zajko W, Bazzarre TL. A proposal for a new screening paradigm and tool called Exercise Assessment and Screening for You (EASY). J Aging Phys Act. 2008 Apr;16(2):215-33. doi: 10.1123/japa.16.2.215.
- Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.
- Schulz R, Burgio L, Burns R, Eisdorfer C, Gallagher-Thompson D, Gitlin LN, Mahoney DF. Resources for Enhancing Alzheimer's Caregiver Health (REACH): overview, site-specific outcomes, and future directions. Gerontologist. 2003 Aug;43(4):514-20. doi: 10.1093/geront/43.4.514. No abstract available.
- Phan T, Steel Z, Silove D. An ethnographically derived measure of anxiety, depression and somatization: the Phan Vietnamese Psychiatric Scale. Transcult Psychiatry. 2004 Jun;41(2):200-32. doi: 10.1177/1363461504043565.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 823071
- K01AG052646 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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