Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Schizophrenia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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 (Outcomes Assessor)Masking Description: people living with schizophrenia, family caregivers, psychiatrists and researchers cannot be blinded for the allocated treatment. The program team conducting the intervention will not be involved in assessing any of the outcomes. The analyses of the data by the researcher will be blinded.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 Ac...

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.

Tracking Information

NCT #
NCT04393896
Collaborators
Not Provided
Investigators
Principal Investigator: Yu Yu, PhD Xiangya Hospital of Central South University