Assessing a WeChat-based integrative family intervention (WIFI) for schizophrenia: protocol for a type 2 hybrid effectiveness-implementation stepped-wedge cluster randomized trial
Authors: YU YU , Li Tong-xin , Xi Shi-jun , Li Yi-lu , Li Qi-rui , Xiao Xi , Yang Min , Ge Xiaoping , Tebes Jacob Kraemer , Xiao Shui yuan 
Published: February 2020

Abstract
Background Schizophrenia is a persistent and debilitating mental illness, whose prognosis depends largely on supportive care and systematic treatment. In 2016, the Chinese government instituted a Reward Policy to financially support family caregiving of serious mental illness, including schizophrenia. However, family caregivers are still faced with many other challenges, such as lack of knowledge about serious mental illness, skills specific to family caregiving, social support, and other resources to assist with caring for a family member with schizophrenia. How to support family caregiving in an accessible, affordable, feasible and cost-effective way remains unresolved. The wide spread use of WeChat provides a promising and cost-effective medium for health intervention delivery. The current study aims to assess a WeChat WeChat-based integrative family intervention (WIFI) embedded in the Reward Policy to support family caregiving of schizophrenia. Methods We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of and the implementation process of the WIFI program. The program will 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. All clusters will receive the usual financial benefit of the Reward Policy as the control condition, and then successively and in random order, will cross over to the WIFI intervention at 2-month intervals until the study ends. 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. All statistical analyses will be conducted according to the intention-to-treat principle. Discussion This is the first hybrid effectiveness-implementation 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. If found to be effective, the intervention could potentially be integrated into current national policy to support family caregiving. The intervention could also be adapted for use with other populations with a persistent and disabling condition.