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Vietnamese Caregiver Intervention Study

Primary Purpose

Alzheimer's Disease (Incl Subtypes), Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced psycho-education about dementia and caregiving
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease (Incl Subtypes) focused on measuring Caregiver, Vietnamese, Alzheimer's Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Randomization
% of eligible dyads who agree to randomization
Retention
Retention in both arms of the study; Note: no formal assessment tool will be used - this will be assessed via number of participants retained
Caregiver Intervention Adherence
% of dyads engaging in the initial session, % completing at least 3 sessions, and % completing all sessions
Treatment Fidelity
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
Administration of Study Measures
% of baseline, post-, and 3-month assessments completed (considering length of assessments and completeness of collected data
Acceptability
Assessed through a questionnaire and interview assessing the perceptions of the intervention by primary and secondary caregivers, CBO staff/administrators, and interventionists.

Secondary Outcome Measures

Alzheimer's Disease Knowledge Scale (ADKS)
This scale assesses knowledge about AD. The scale has 30 statements. Subjects are asked to rate each statement as True or False.
Caregiver Self-Efficacy
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.
Center for Epidemiological Studies Depression (CES-D) scale
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.
Zarit Burden Inventory (ZBI)
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).
Quality of Life - Alzheimer's Disease (QoL-AD)
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.
Perceived Stress Scale
This scale asks subjects about how often they have felt or thought about 10 items during the past month.

Full Information

First Posted
June 12, 2017
Last Updated
October 6, 2021
Sponsor
University of California, Davis
Collaborators
National Institute on Aging (NIA), Alzheimer's Association
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1. Study Identification

Unique Protocol Identification Number
NCT03218982
Brief Title
Vietnamese Caregiver Intervention Study
Official Title
A Culturally-Relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institute on Aging (NIA), Alzheimer's Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (Incl Subtypes), Cognitive Impairment
Keywords
Caregiver, Vietnamese, Alzheimer's Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Families will then be randomized (as a team) to either the active intervention or the control condition. Caregivers in the active intervention will then be scheduled for six weekly intervention sessions, lasting about 2 hours each. Following the completion of the sessions, primary caregivers will complete assessment measures (that they completed at baseline) immediately after the intervention (post) and at three months. This is expected to take one hour for each assessment. Primary caregivers assigned to the control condition will also complete these assessment measures around the same those in the active intervention complete them. These caregivers will also have the option of participating in the active intervention after the three-month follow up.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced psycho-education about dementia and caregiving
Other Intervention Name(s)
management of problem behaviors, facilitation of support-seeking, mindful Tai Chi
Intervention Description
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.
Primary Outcome Measure Information:
Title
Randomization
Description
% of eligible dyads who agree to randomization
Time Frame
assessed once all 3-month follow-ups are complete
Title
Retention
Description
Retention in both arms of the study; Note: no formal assessment tool will be used - this will be assessed via number of participants retained
Time Frame
assessed once all 3-month follow-ups are complete
Title
Caregiver Intervention Adherence
Description
% of dyads engaging in the initial session, % completing at least 3 sessions, and % completing all sessions
Time Frame
assessed at end of study, once all 3-month follow-ups are complete
Title
Treatment Fidelity
Description
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
Time Frame
assessed once all 3-month follow-ups are complete
Title
Administration of Study Measures
Description
% of baseline, post-, and 3-month assessments completed (considering length of assessments and completeness of collected data
Time Frame
assessed at end of study, once all 3-month follow-ups are complete
Title
Acceptability
Description
Assessed through a questionnaire and interview assessing the perceptions of the intervention by primary and secondary caregivers, CBO staff/administrators, and interventionists.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Knowledge Scale (ADKS)
Description
This scale assesses knowledge about AD. The scale has 30 statements. Subjects are asked to rate each statement as True or False.
Time Frame
Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Title
Caregiver Self-Efficacy
Description
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.
Time Frame
Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Title
Center for Epidemiological Studies Depression (CES-D) scale
Description
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.
Time Frame
Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Title
Zarit Burden Inventory (ZBI)
Description
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).
Time Frame
Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Title
Quality of Life - Alzheimer's Disease (QoL-AD)
Description
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.
Time Frame
Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Title
Perceived Stress Scale
Description
This scale asks subjects about how often they have felt or thought about 10 items during the past month.
Time Frame
Baseline, 6-weeks (Post-intervention), 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oanh Meyer, PhD, MAS
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers.
Citations:
PubMed Identifier
26617956
Citation
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.
Results Reference
background
PubMed Identifier
18483443
Citation
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.
Results Reference
background
PubMed Identifier
12218768
Citation
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.
Results Reference
background
PubMed Identifier
2594878
Citation
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.
Results Reference
background
PubMed Identifier
19363018
Citation
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.
Results Reference
background
PubMed Identifier
12028884
Citation
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.
Results Reference
background
PubMed Identifier
16250744
Citation
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.
Results Reference
background
PubMed Identifier
8628042
Citation
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.
Results Reference
background
PubMed Identifier
11574710
Citation
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.
Results Reference
background
PubMed Identifier
12937330
Citation
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.
Results Reference
background
PubMed Identifier
12021425
Citation
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.
Results Reference
background
PubMed Identifier
6668417
Citation
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.
Results Reference
background
PubMed Identifier
15446721
Citation
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.
Results Reference
background

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Vietnamese Caregiver Intervention Study

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