Vietnamese Caregiver Intervention Study

NCT03218982 | Completed

• 2 other identifiers: 823071K01AG052646
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease (Incl Subtypes); Cognitive Impairment

Keywords

Caregiver; Vietnamese; Alzheimer's Disease

Outcome Measures

Primary Outcomes (6)

• Randomization

  % of eligible dyads who agree to randomization

  assessed once all 3-month follow-ups are complete

• 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

  assessed once all 3-month follow-ups are complete

• Caregiver Intervention Adherence

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

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

• 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

  assessed once all 3-month follow-ups are complete

• Administration of Study Measures

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

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

• Acceptability

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

  2 years

Secondary Outcomes (6)

• Alzheimer's Disease Knowledge Scale (ADKS)

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

• Caregiver Self-Efficacy

  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

• 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

Study Arms (2)

Active Intervention

EXPERIMENTAL

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.

Behavioral: Enhanced psycho-education about dementia and caregiving

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: management of problem behaviors, facilitation of support-seeking, mindful Tai Chi

Active Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute on Aging (NIA): collaborator
• Alzheimer's Association: collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (13)

• 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.

  PMID: 26617956 BACKGROUND

• 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.

  PMID: 18483443 BACKGROUND

• 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.

  PMID: 12218768 BACKGROUND

• 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.

  PMID: 2594878 BACKGROUND

• 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.

  PMID: 19363018 BACKGROUND

• 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.

  PMID: 12028884 BACKGROUND

• 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.

  PMID: 16250744 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 11574710 BACKGROUND

• 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.

  PMID: 12937330 BACKGROUND

• 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.

  PMID: 12021425 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 15446721 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Oanh Meyer, PhD, MAS

  University of California, Davis

  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: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: July 17, 2017
• Study Start: May 22, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 31, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)