SchizophreniaNCT04393896
Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia
A study testing WeChat-based integrative family intervention (WIFI) in people with Schizophrenia, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- WeChat-based integrative family intervention (WIFI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia: a Stepped-wedge Cluster Randomized Trial
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- WeChat-based integrative family intervention (WIFI)
- Keywords
- Schizophrenia, Family intervention, WeChat, Stepped wedge, Psycho-education, Peer support, Professional support
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeChat-based integrative family intervention (WIFI)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Sep 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Yu, PhD, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393896
- Sponsor's protocol ID
- 71804197
- Status last verified
- May 2020
- First submitted
- 27 Jan 2020
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28628657Yu 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.
PubMed 30618960Yu 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.
PubMed 29684660Yu 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.
PubMed 30332924Yu 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.
PubMed 30588138Yu 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.
PubMed 32687478
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia: a Stepped-wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT04393896
- Acronym / sponsor ID
- 71804197
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Family intervention, WeChat, Stepped wedge, Psycho-education, Peer support, Professional support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: WeChat-based integrative family intervention (WIFI)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- joining the Reward Policy and receiving a subsidy for family care
Key exclusion criteria (7 listed)
- diagnosed with mental illness other than schizophrenia
- living alone with no family members
- not able to use smartphones or WeChat
- not involved with caregiving activities for the schizophrenia individuals
- not able to use smartphones or WeChat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeChat-based integrative family intervention (WIFI)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 | Behavioural | intervention group |
Primary outcome
caregiver burden at baseline
Time frame: 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.
caregiver burden at month 2
Time frame: 2 months
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.
caregiver burden at month 4
Time frame: 4 months
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.
caregiver burden at month 6
Time frame: 6 months
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.
caregiver burden at month 8
Time frame: 8 months
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.
2 secondary outcomes
Depression
Time frame: 8 months
Anxiety
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Background: PubMed 28628657Yu 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.
- Background: PubMed 30618960Yu 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.
- Background: PubMed 29684660Yu 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.
- Background: PubMed 30332924Yu 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.
- Background: PubMed 30588138Yu 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.
- Derived from this study: PubMed 32687478Yu 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Yu, PhD principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeChat-based integrative family intervention (WIFI) in people with Schizophrenia, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Yu, PhD (+8618774897811, 403616846@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caregiver burden at baseline (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393896, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.