Clinical trial NCT04393896: Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia
Official title: Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia: a Stepped-wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Family intervention
WeChat
Stepped wedge
Psycho-education
Peer support
Professional support
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: caregiver burden at baseline
timeFrame: baseline
measure: caregiver burden at month 2
timeFrame: 2 months
measure: caregiver burden at month 4
timeFrame: 4 months
measure: caregiver burden at month 6
timeFrame: 6 months
measure: caregiver burden at month 8
timeFrame: 8 months
Secondary outcomes:
measure: Depression
timeFrame: 8 months
measure: Anxiety
timeFrame: 8 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yu Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu Y, Liu ZW, Tang BW, Zhao M, Liu XG, Xiao SY. Reported family burden of schizophrenia patients in rural China. PLoS One. 2017 Jun 19;12(6):e0179425. doi: 10.1371/journal.pone.0179425. eCollection 2017.
citation: Yu Y, Liu ZW, Zhou W, Chen XC, Zhang XY, Hu M, Xiao SY. Assessment of Burden Among Family Caregivers of Schizophrenia: Psychometric Testing for Short-Form Zarit Burden Interviews. Front Psychol. 2018 Dec 19;9:2539. doi: 10.3389/fpsyg.2018.02539. eCollection 2018.
citation: Yu Y, Tang BW, Liu ZW, Chen YM, Zhang XY, Xiao S. Who cares for the schizophrenia individuals in rural China - A profile of primary family caregivers. Compr Psychiatry. 2018 Jul;84:47-53. doi: 10.1016/j.comppsych.2018.04.002. Epub 2018 Apr 11.
citation: Yu Y, Zhou W, Xiao S. China's Reward Policy for Family Care of Persons With Serious Mental Illness. Psychiatr Serv. 2018 Dec 1;69(12):1210-1211. doi: 10.1176/appi.ps.201800114. Epub 2018 Oct 18.
citation: Yu Y, Zhou W, Liu ZW, Hu M, Tan ZH, Xiao SY. Gender differences in caregiving among a schizophrenia population. Psychol Res Behav Manag. 2018 Dec 20;12:7-13. doi: 10.2147/PRBM.S187975. eCollection 2019.
citation: Yu Y, Li T, Xi S, Li Y, Xiao X, Yang M, Ge X, Xiao S, Tebes J. Assessing a WeChat-Based Integrative Family Intervention (WIFI) for Schizophrenia: Protocol for a Stepped-Wedge Cluster Randomized Trial. JMIR Res Protoc. 2020 Aug 25;9(8):e18538. doi: 10.2196/18538.