Assessing a WeChat-based integrative family intervention (WIFI) for schizophrenia: protocol for a stepped-wedge cluster randomized trial (Preprint)

BACKGROUND Schizophrenia is a persistent and debilitating mental illness, whose prognosis depends largely on supportive care and systematic treatment. In developing countries like China, family constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills and resources. How to support family caregiving in an accessible, affordable, feasible and cost-effective way remains unresolved. The widely spread use of WeChat provides a promising and cost-effective medium for support. OBJECTIVE The current study aims to assess a WeChat WeChat-based integrative family intervention (WIFI) to support family caregiving of schizophrenia. METHODS A WIFI program will be developed that include three core components: 1) psycho-education through WeChat Official Account (WOA), 2) peer support through WeChat chat group, and 3) professional support through WeChat video chat. A rigorous stepped wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with the Changsha psychiatric hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every two months during an 8-month intervention period in four clusters of 3 communities each. Outcomes will be assessed for both family caregivers and the family member with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support and coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. Schizophrenia individuals will be assessed for their symptoms and functioning, quality of life, recovery and rehospitalization. Cost data such as costs of the intervention, health care utilization, and costs associated with lost productivity will also be collected. In addition, we will collect process data including fidelity and quality of program implementation as well as users' attitudes will also be collected. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling (GLMM) with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost effectiveness ratios (ICERs). Qualitative analysis will use the grounded theory approach and immersion-crystallization process. RESULTS The study was funded in August 2018, approved by IRB on Jan 15th 2019. Preliminary baseline data collection was conducted in May 2019 and completed in Sep 2019. The WIFI intervention is expected to start in May 2020. CONCLUSIONS This is the first study to test a WeChat-based mHealth intervention to support family caregiving of schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for schizophrenia individuals, and potentially be integrated into national policy and adapted for use with other populations. CLINICALTRIAL Nct04393896.