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Open Access 01-12-2022 | Alzheimer's Disease | Study protocol

Resources for Enhancing Alzheimer’s Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam

Authors: Duyen Tran, Huong Nguyen, Thang Pham, Anh T. Nguyen, Hung T. Nguyen, Ngoc B. Nguyen, Bien H. Nguyen, Danielle Harvey, Laura Gitlin, Ladson Hinton

Published in: Trials | Issue 1/2022

Abstract

Background

Alzheimer’s disease and related dementias (AD/ADRD) are a public health challenge for Vietnam because of its rapidly aging population. However, very few community-based programs exist to support people living with AD/ADRD and their family caregivers. Resources for Enhancing Alzheimer’s Caregiver Health in Vietnam (REACH VN) is a culturally adapted family caregiver intervention shown in a pilot study to be feasible and promising in terms of preliminary efficacy. We describe the protocol for a larger cluster randomized controlled trial (RCT) to test the efficacy of REACH VN among family caregivers of people living with dementia in a semi-rural area outside of Hanoi, Vietnam.

Methods

Thirty-two clusters with approximately 350 caregivers will be randomized to either REACH VN intervention or enhanced usual care. REACH VN is a multicomponent intervention delivered in-home or by phone over the course of 2 to 3 months. To be eligible, family caregivers need to be ≥18 years old, be the person who provides the most day-to-day care for people living with dementia, and have a score ≥ 6 on the Zarit Burden Interview-4. The primary outcomes are caregiver burden (Zarit Burden Interview-12) and psychological distress (Patient Health Questionnaire-4). Secondary outcomes include caregiver somatic symptoms (Patient Health Questionnaire-15) and perceived stress (Perceived Stress Scale-10). These outcomes will be assessed at baseline, 3 months, and 6 months. Exploratory analyses to examine potential mediators of primary outcomes are also planned.

Discussion

To our knowledge, this is the first large-scale study to test the efficacy of a community-based family dementia caregiver intervention in Vietnam. Results from this study will help inform efforts to widely deliver the REACH VN intervention or similar community-based family dementia caregiver support programs in Vietnam and other low- and middle-income countries (LMIC).

Trial registration

ClinicalTrials.govNCT04542317. Registered on 9 September 2020

Prince M, Wimo A, Guerchet M, Ali G, Wu Y, Prina M, et al. World Alzheimer Report 2015 - The global impact of dementia: an analysis of prevalence, incidence, cost and trends. London: Alzheimer's Disease International; 2015.

Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013;9(1):63–75.e2. https://doi.org/10.1016/j.jalz.2012.11.007.CrossRefPubMed

Fam J, Mahendran R, Kua EH. Dementia care in low and middle-income countries. Curr Opin Psychiatry. 2019;32(5):461–4. https://doi.org/10.1097/YCO.0000000000000523.CrossRefPubMed

Nguyen NB, Do HTK, Kim G, Hoang MV, Nguyen DTT, Nguyen LH, et al. Assessing caregiver burden in Alzheimer’s disease. Vietnam J Prev Med. 2013;5(141):88–94.

Nguyen H, Nguyen T, Tran D, Hinton L. “It’s extremely hard but it's not a burden”: a qualitative study of family caregiving for people living with dementia in Vietnam. PLoS One. 2021;16(11):e0259788. https://doi.org/10.1371/journal.pone.0259788.CrossRefPubMedPubMedCentral

The Law on the Elderly. Vietnam: The Vietnam National Congress; 2010.

HelpAge Asia. Ageing population in Vietnam; 2019. Available from: https://ageingasia.org/ageing-population-vietnam/

Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217–28. https://doi.org/10.31887/DCNS.2009.11.2/hbrodaty.CrossRefPubMedPubMedCentral

Nguyen TB, Nguyen H, Nguyen TH, Nguyen T, Nguyen PA, Nguyen QP, et al. Introducing the American REACH-VA intervention for family caregivers of people with dementia and implications for family caregiver interventions in Vietnam. Vietnam Med J. 2018;468(1):98–101.

10.

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;6(3):263–72. https://doi.org/10.1037/aap0000024.CrossRefPubMedPubMedCentral

11.

Gitlin L, Marx K, Stanley IH, Hodgson N. Translating evidence-based dementia caregiving interventions into practice: State-of-the-science and next steps. Gerontologist. 2015;55(2):210–26. https://doi.org/10.1093/geront/gnu123.CrossRefPubMedPubMedCentral

12.

Walter E, Pinquart M. How effective are dementia caregiver interventions? An updated comprehensive meta-analysis. Gerontologist. 2020;60(8):609–19. https://doi.org/10.1093/geront/gnz118.CrossRefPubMed

13.

Ta Park VM, Ton V, Tiet QQ, Vuong Q, Yeo G, Gallagher-Thompson D. Promising results from a pilot study to reduce distress in Vietnamese American dementia and memory loss caregivers. Alzheimers Dement (N Y). 2019;5(1):319–27. https://doi.org/10.1016/j.trci.2019.05.006.CrossRef

14.

Ta Park VM, Ton V, Yeo G, Tiet QQ, Vuong Q, Gallagher-Thompson D. Vietnamese American dementia caregivers’ perceptions and experiences of a culturally tailored, evidence-based program to reduce stress and depression. J Gerontol Nurs. 2019;45(9):39–50. https://doi.org/10.3928/00989134-20190813-05.CrossRefPubMed

15.

Meyer OL, Sun M, Do T, Ho JN, Dinh BT, Nguyen S, et al. Community-engaged research with Vietnamese Americans to pilot-test a dementia caregiver intervention. J Cross Cult Gerontol. 2020;35(4):479–92. https://doi.org/10.1007/s10823-020-09410-y.CrossRefPubMedPubMedCentral

16.

Hinton L, Tran D, Nguyen TN, Ho J, Gitlin L. Interventions to support family caregivers of people living with dementia in high, middle and low-income countries in Asia: a scoping review. BMJ Glob Health. 2019;4(6):e001830. https://doi.org/10.1136/bmjgh-2019-001830.CrossRefPubMedPubMedCentral

17.

Nichols LO, Martindale-Adams J, Burns R, Zuber J, Graney MJ. REACH VA: Moving from translation to system implementation. Gerontologist. 2016;56(1):135–44. https://doi.org/10.1093/geront/gnu112.CrossRefPubMed

18.

Martindale-Adams J, Tah T, Finke B, LaCounte C, Higgins BJ, Nichols LO. Implementation of the REACH model of dementia caregiver support in American Indian and Alaska Native communities. Transl Behav Med. 2017;7(3):427–34. https://doi.org/10.1007/s13142-017-0505-1.CrossRefPubMedPubMedCentral

19.

Czaja SJ, Lee CC, Perdomo D, Loewenstein D, Bravo M, Moxley P, et al. Community REACH: an implementation of an evidence-based caregiver program. The Gerontologist. 2018;58(2):e130–e7. https://doi.org/10.1093/geront/gny001.CrossRefPubMed

20.

Cheung KSL, Lau BHP, Wong PWC, Leung AYM, Lou VW, Chan GMY, et al. Multicomponent intervention on enhancing dementia caregiver well-being and reducing behavioral problems among Hong Kong Chinese: a translational study based on REACH II. Int J Geriatr Psychiatry. 2015;30(5):460–9. https://doi.org/10.1002/gps.4160.CrossRefPubMed

21.

Nichols LO, Martindale-Adams J, Burns R, Graney MJ, Zuber J. Translation of a dementia caregiver support program in a health care system--REACH VA. Arch Intern Med. 2011;171(4):353–9. https://doi.org/10.1001/archinternmed.2010.548.CrossRefPubMed

22.

Nguyen TA, Nguyen H, Pham T, Nguyen TH, Hinton L. A cluster randomized controlled trial to test the feasibility and preliminary effectiveness of a family dementia caregiver intervention in Vietnam: The REACH VN study protocol. Medicine. 2018;97(42):12553. https://doi.org/10.1097/MD.0000000000012553.CrossRef

23.

Hinton L, Nguyen H, Nguyen HT, Harvey DJ, Nichols L, Martindale-Adams J, et al. Advancing family dementia caregiver interventions in low- and middle-income countries: a pilot cluster randomized controlled trial of Resources for Advancing Alzheimer’s Caregiver Health in Vietnam (REACH VN). Alzheimers Dement (N Y). 2021;6(1):e12063. https://doi.org/10.1002/trc2.12063.CrossRef

24.

Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning clinical science: unifying the discipline to improve the public health. Clin Psychol Sci. 2014;2(1):22–34. https://doi.org/10.1177/2167702613497932.CrossRefPubMedPubMedCentral

25.

Bédard 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;41(5):652–7. https://doi.org/10.1093/geront/41.5.652.CrossRefPubMed

26.

Yu J, Yap P, Liew TM. The optimal short version of the Zarit Burden Interview for dementia caregivers: diagnostic utility and externally validated cutoffs. Aging Ment Health. 2019;23(6):706–10. https://doi.org/10.1080/13607863.2018.1450841.CrossRefPubMed

27.

Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, et al. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006;145(10):727–38. https://doi.org/10.7326/0003-4819-145-10-200611210-00005.CrossRefPubMedPubMedCentral

28.

Kroenke K, Spitzer RL, Williams JB, Löwe B. An ultra-brief screening scale for anxiety and depression: The PHQ-4. Psychosomatics. 2009;50(6):613–21. https://doi.org/10.1176/appi.psy.50.6.613.CrossRefPubMed

29.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385–96. https://doi.org/10.2307/2136404.CrossRefPubMed

30.

Kroenke K, Spitzer RL, Williams JB. The PHQ-15: Validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002;64(2):258–66. https://doi.org/10.1097/00006842-200203000-00008.CrossRefPubMed

31.

Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002;6(2):153–60. https://doi.org/10.1080/13607860220126763.CrossRefPubMed

32.

Nguyen PT, Nguyen N, Vo K, Ho S, Nguyen J, Woo BK. Knowledge of dementia among Vietnamese American immigrants. Asian J Psychiatr. 2016;20:39–40. https://doi.org/10.1016/j.ajp.2015.11.005.CrossRefPubMed

33.

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. https://doi.org/10.1016/j.jbi.2008.08.010.CrossRefPubMed

34.

Glasgow RE, Lichtenstein E, Marcus AC. Why don’t we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. Am J Public Health. 2003;93(8):1261–7. https://doi.org/10.2105/ajph.93.8.1261.CrossRefPubMedPubMedCentral

35.

Nguyen TA, Pham T, Dang TH, Hinton WL, Nguyen AT, Pham TL, et al. Towards the development of Vietnam's national dementia plan-the first step of action. Australas J Ageing. 2020;39(2):137–41. https://doi.org/10.1111/ajag.12755.CrossRefPubMed

Title: Resources for Enhancing Alzheimer’s Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam
Authors: Duyen Tran
Huong Nguyen
Thang Pham
Anh T. Nguyen
Hung T. Nguyen
Ngoc B. Nguyen
Bien H. Nguyen
Danielle Harvey
Laura Gitlin
Ladson Hinton
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Alzheimer's Disease
Dementia
Alzheimer's Disease
Dementia
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06228-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Resources for Enhancing Alzheimer’s Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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