Hinton 2021.
| Study characteristics | |
| Methods |
Study design: cluster‐RCT Duration of study: the study was conducted in 2018. Country: Vietnam Income classification: low‐middle‐income country in 2018 Geographical scope: semirural area outside of Hanoi, Vietnam Healthcare setting: home or other place of choice |
| Participants | 1. Age: control 58.7 years (13.9); intervention 59.0 years (10.4) 2. Gender: both 3. Socioeconomic background: not specified 4. Educational background: control 7.2 years (2.6); intervention 8.3 years (3.4) of education Inclusion criteria: a. age 18 or older; b. family member most involved in the dementia patient’s day‐to‐day care; c. score on the Zarit Burden Interview (ZBI) (4‐item) of ≥ 6; d. caring for an older adult with a dementia diagnosis and a Clinical Dementia Rating (CDR) score of 1 or above. Exclusion criteria: caregivers identified as having difficulties in the consent process due to cognitive impairment or severe sensory impairment. Note: at baseline, the intervention and control group scores for Patient Health Questionnaire 4 (PHQ‐4) were, respectively, 4.1 (3.0) and 4.6 (2.8). Stated purpose: to assess the efficacy and feasibility of a family caregiving intervention in northern Vietnam |
| Interventions |
Name: REACH VN Title/name of PW and number: community workers/interventionist (number not specified) 1. Selection: not specified 2. Educational background: not specified 3. Training: training of interventionists in Vietnam consisted of didactic sessions based on the REACH VA training materials as well as “hands‐on” field experience in a case series prior to the study onset in. The training was carried out by certified by a senior member of the research team (HN) who is bilingual and was herself certified by the REACH VA intervention by the Memphis Caregiver Center affiliated with the University of Tennessee. 4. Supervision: after each session, an observer will complete the Treatment Delivery Form to document the delivery of key components of the intervention. 5. Incentives/remuneration: not specified Prevention type: indicated – participants, caregivers of people with dementia, presented with some level of distress as indicated by the PHQ‐4 scores at baseline. Intervention details: participants in the intervention group will receive a culturally adapted intervention based on the REACH VA intervention. The intervention itself consists of 4 “core” training sessions on problem‐solving, mood management/cognitive restructuring, stress management (e.g. signal breath, mindfulness medication, pleasant event scheduling), and communication, plus up to 2 additional sessions based on the caregiver’s needs and clinical judgement and will be delivered over the course of 2 to 3 months. Each session lasts approximately 1 hour and will be delivered by an interventionist certified to deliver the intervention. The interventionist will deliver face‐to‐face, but there will also be the option of conducting sessions by phone. At the first session, each participant will receive written materials on dementia as well as a caregiver notebook with detailed information on a variety of topics related to dementia caregiving and will serve as a reference during the intervention. Control: enhanced usual care – the enhanced control condition will consist of a single face‐to face session that will occur at the time of enrolment and be held in the caregiver’s home (or another place of their choosing). Caregivers will be educated about the nature of dementia and provided with written educational materials. |
| Outcomes |
Participants’outcomes of interest for this review
Note: data in the adult population, as only caregivers received the intervention (not patients with dementia) Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (< 1 month) |
| Notes |
Source of funding: National Institute on Aging and Fogarty International Center of the National Institutes of Health under award number R21AG054262 (Hinton and Nguyen MPI) Notes on validation of instruments (screening and outcomes): the selected measures are widely adopted and validated across contexts (PHQ, ZBI). Additional information: none Handling the data: not applicable Prospective trial registration number: NCT03587974 |