Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The study aims to test both the effectiveness and implementation strategy of a WeChat-based integrative family intervention (WIFI) to support family caregiving of schizophrenia in China.

Detailed Description
-----------------
The investigators will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of and the implementation process of a WeChat-based integrative family intervention (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. 20 families of schizophrenia will be selected from each community. 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 program 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 re-hospitalization. Cost data such as costs of the intervention, health care utilization, and costs associated with lost productivity will also be collected. In addition, the investigators 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.

Official Title
-----------------
Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia: a Stepped-wedge Cluster Randomized Trial

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: WeChat-based integrative family intervention (WIFI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For people living with schizophrenia: being registered in the 686 Program fulfilling the Chinese Classification of Mental Disorders-3 (CCMD-3) or the International Classification of Diseases-10 (ICD-10) criteria for schizophrenia living with at least one family member able to use a smartphone and WeChat to read and communicate For family members: joining the Reward Policy and receiving a subsidy for family care living with schizophrenia individuals for at least the past two years involved with caregiving activities of schizophrenia individuals able to use a smartphone and WeChat to read and communicate at least one family member having a smartphone with WeChat app installed. Exclusion Criteria: For people living with schizophrenia: diagnosed with mental illness other than schizophrenia living alone with no family members not able to use smartphones or WeChat For family members: not involved with caregiving activities for the schizophrenia individuals not able to use smartphones or WeChat

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a stepped-wedge cluster randomized trial. The WeChat-based integrative family intervention (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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Participants in the intervention group will receive the usual financial benefits of the Reward Policy as well as the WIFI program which will include three key components: psycho-education through WOA publications, peer-support through a WeChat chat group, and professional support through WeChat private chat and video call. | Behavioral: WeChat-based integrative family intervention (WIFI)<br>* The WIFI program will include three key components: psycho-education through WeChat Official Account publications, peer-support through a WeChat chat group, and professional support through WeChat private chat and video call<br>|
| No Intervention: control group<br>Participants in the control group will receive the usual financial benefits of the Reward Policy and receive payment from the Changsha psychiatric hospital. However, they will not have access to the WIFI program since they cannot scan the WeChat barcode for the research. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caregiver burden at baseline | caregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) at baseline. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden. | baseline | 
| caregiver burden at month 2 | caregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 2 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden. | 2 months | 
| caregiver burden at month 4 | caregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 4 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden. | 4 months | 
| caregiver burden at month 6 | caregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 6 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden. | 6 months | 
| caregiver burden at month 8 | caregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 8 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Depression will be measured using the internationally standard depression scale---Patient Health Questionnaire-9 (PHQ-9) at baseline, 2 months, 4 months, 6 months, 8 months. The total score ranges from 0 to 27, with higher score indicating more depressive symptoms. | 8 months | 
| Anxiety | Anxiety will be measured using the internationally standard anxiety scale---Generalized Anxiety Disorder Scale-7 (GAD-7) at baseline, 2 months, 4 months, 6 months, 8 months. The total score ranges from 0 to 27, with higher score indicating more anxiety symptoms. | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family intervention, Peer support, Professional support, Schizophrenia, WeChat, Stepped wedge, Psycho-education