NCT04393896

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 9, 2021

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

January 27, 2020

Last Update Submit

April 8, 2021

Conditions

Schizophrenia

Keywords

SchizophreniaFamily interventionWeChatStepped wedgePsycho-educationPeer supportProfessional support

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Depression

    8 months

  • Anxiety

    8 months

Study Arms (2)

intervention group

EXPERIMENTAL

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)

control group

NO INTERVENTION

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.

Interventions

WeChat-based integrative family intervention (WIFI)BEHAVIORAL

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

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

Location

Related Publications (6)

  • 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.

    PMID: 28628657BACKGROUND

  • 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.

    PMID: 30618960BACKGROUND

  • 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.

    PMID: 29684660BACKGROUND

  • 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.

    PMID: 30332924BACKGROUND

  • 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.

    PMID: 30588138BACKGROUND

  • 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.

    PMID: 32687478DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Yu Yu, PhD

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Yu, PhD

CONTACT

+8618774897811403616846@qq.com

Tongxin Li, Master

CONTACT

+15274984256tongxin@csu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

May 19, 2020

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 9, 2021

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Since the official start of the trial to the end of the trial
Access Criteria
Describe clearly about the reason of review

Locations

CN(1)