Congenital Heart DiseaseCHD-HomeCareNCT07385209
Design and Application of a Home Care WeChat Mini-Program for Children After Congenital Heart Disease Surgery
A study testing Home Care WeChat Mini-Program and Routine Care with Telephone Follow-up in people with Congenital Heart Disease, run by ruijie YangLan at 1 site in China.
Trial summary
This is a single-blind, randomized controlled trial aimed at evaluating the effectiveness of a family-centered, WeChat-based home care mini-program for children after congenital heart disease (CHD) surgery. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Home Care WeChat Mini-Program and Routine Care with Telephone Follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - The child is ≤12 years old.
- The child has been diagnosed with congenital heart disease (CHD) and is scheduled for or has undergone corrective surgery.
- The child is in a stable medical condition (non-acute phase).
- At least one primary caregiver (parent or sibling >12 years old) of the child agrees to participate.
- The caregiver provides written informed consent to participate in the study.
Who cannot join
- - The child has severe developmental defects.
- The child has other major diseases that significantly affect quality of life.
- The caregiver has visual, hearing, or cognitive impairments that hinder communication.
- The caregiver has a diagnosed psychiatric disorder.
- The caregiver is unconscious or otherwise unable to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Fang Ma, professor of nursing, +86 18887278258, 1052076436@qq.com
ruijie YangLan, postgraduate student, +86 18887278258, 1052076436@qq.com
About this study
Official title: Design and Application of a Home Care Mini-Program for Children With Congenital Heart Disease After Discharge: A Randomized Controlled Trial
This is a single-blind, randomized controlled trial aimed at evaluating the effectiveness of a family-centered, WeChat-based home care mini-program for children after congenital heart disease (CHD) surgery. Given the chronic nature of post-operative CHD management and the significant stress placed on families, this study shifts from a deficit-based to a strengths-based perspective, guided by the Double ABC-X model. Children (≤12 years old) who have undergone CHD surgery and their primary caregivers will be recruited. Participants will be randomly assigned to either the intervention group, which uses the mini-program for health education, peer support, and physiological monitoring, or the control group, which receives routine telephone follow-up. The primary outcomes are family health (measured by the Family Health Scale), family stress, and the quality of life for both the child and caregivers. Secondary outcomes include physiological parameters such as the 6-minute walk test distance. The study aims to provide evidence for a scalable digital health intervention to support long-term family adaptation and child recovery.
Read the detailed description
- Background and Rationale Congenital heart disease (CHD) is the most common birth defect globally, with a high prevalence in China. While surgical advances have significantly improved survival rates, CHD has transitioned into a chronic condition requiring long-term management. The post-discharge period places immense stress on families, affecting caregiver well-being, family functioning, and the child's recovery. Existing home care models often focus on the child's deficits or rely on resource-intensive methods (e.g., home visits). Guided by the Double ABC-X model of family adaptation, this study adopts a family strengths-based perspective. It aims to develop and test a digital, interactive home care mini-program designed to support family resources, promote positive adaptation, and improve health outcomes after CHD surgery.
- Study Objectives Primary Objective: To evaluate the effectiveness of a family-centered, WeChat-based home care mini-program on improving family health in households with children after CHD surgery. Secondary Objectives: To assess the program's impact on: 1) reducing family stress, 2) enhancing the quality of life of both the child and primary caregivers, and 3) improving the child's physiological recovery indicators.
- Study Design This is a prospective, two-arm, parallel-group, assessor-blinded, randomized controlled trial (RCT). Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
- Participants, Setting, and Timeline Participants: Families (the child who underwent surgery and their primary caregiver/parent) of children (≤12 years old) with CHD after surgical intervention. Setting: Recruitment and baseline assessment will be conducted at a tertiary hospital in Yunnan Province, China. The intervention and follow-up will be home-based. Sample Size: 210 families (105 per group), calculated with 80% power, a significance level of 0.05, an effect size (δ/σ) of 0.5, and accounting for 20% attrition. Timeline: Study Start Date (first enrollment): December 2025. Primary Completion Date (last participant's final data collection for primary outcome): December 2026. Study Completion Date: January 2027.
- Interventions Intervention Group: Will receive access to the "CHD Postoperative Home Care" WeChat mini-program in addition to routine care. The mini-program includes three core modules: Education Module: Provides multimedia (text, images, video) health information on post-operative care, nutrition, medication, activity guidance, and complication monitoring. Interactive Support Module: Features a secure peer-support community for sharing experiences (digital narrative therapy) and a direct communication channel for families to consult the healthcare team. Monitoring \& Alert Module: Allows families to log and submit key health data (e.g., weight, symptoms). The system includes automated alerts for concerning values and prompts for scheduled follow-up assessments. The research team will remotely monitor this data and initiate follow-up calls if alerts are triggered. Control Group: Will receive routine postoperative care, which includes standard discharge instructions and scheduled telephone follow-ups by hospital staff at 1, 3, and 6 months post-discharge.
- Outcome Measures and Assessment Timepoints Assessments will occur at baseline (T0, pre-discharge) and at 1 (T1), 3 (T2), and 6 (T3) months post-discharge. Primary Outcomes: Family Health: Measured by the Chinese version of the Family Health Scale (FHS). Family Stress: Measured by the Congenital Heart Disease Family Stressor Scale. Quality of Life of Caregivers: Measured by the 36-Item Short Form Health Survey (SF-36). Quality of Life of the Child: Measured by the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cardiac Module. Secondary Outcomes (Child Physiological Measures): Functional Capacity: 6-Minute Walk Test distance. Growth: Body weight. Cardiac Function: Heart rate and Left Ventricular Ejection Fraction (via echocardiogram).
- Randomization, Blinding, and Data Analysis Randomization: After baseline assessment, eligible families will be randomly assigned using computer-generated random numbers sealed in opaque envelopes. Blinding: Outcome assessors and data analysts will be blinded to group allocation. Due to the nature of the intervention, participants and intervention facilitators cannot be blinded. Statistical Analysis: Data will be analyzed using SPSS software. Baseline characteristics will be compared using t-tests, chi-square, or Mann-Whitney U tests. Primary and secondary outcomes will be analyzed using Linear Mixed Models (LMM) for repeated measures to examine group, time, and interaction effects.
- Ethical Considerations The study protocol has been submitted for approval to the Institutional Review Board of Kunming Medical University. Written informed consent will be obtained from all participating caregivers. The study will adhere to principles of confidentiality, beneficence, and the right to withdraw without penalty.
- Conditions
- Congenital Heart Disease
- Being tested
- Home Care WeChat Mini-Program, Routine Care with Telephone Follow-up
- Keywords
- home care, mobile health, postoperative rehabilitation, caregiver support
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Care WeChat Mini-ProgramDevice
A family-centered WeChat mini-program providing health education, peer support, and remote monitoring for post-operative care.
Routine Care with Telephone Follow-upOther
Participants in this group will receive standard post-discharge care as per hospital protocol, which includes initial discharge education and scheduled telephone follow-ups by hospital staff at 1, 3, and 6 months post-discharge to assess the child's status and answer questions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receiving the WeChat mini-program intervention. Receives: Other: Routine Care with Telephone Follow-up |
| Control Group | Active comparator | Participants receiving routine care with telephone follow-up. Receives: Device: Home Care WeChat Mini-Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Health Score
Score on the Chinese version of the Family Health Scale (FHS).
Measured: Change from Baseline at 6 months post-discharge
Family Stress Score
Score on the Congenital Heart Disease Family Stressor Scale.
Measured: Change from Baseline at 6 months post-discharge
Child's Quality of Life Score
Score on the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cardiac Module.
Measured: Change from Baseline at 6 months post-discharge
Caregiver's Quality of Life Score
Score on the 36-Item Short Form Health Survey (SF-36).
Measured: Change from Baseline at 6 months post-discharge
Secondary outcomes (2)
Body Weight
Body weight measured in kilograms.
Measured: Measured at 1, 3, and 6 months post-discharge
Left Ventricular Ejection Fraction
Percentage measured by echocardiogram.
Measured: Measured at 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ruijie YangLan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ruijie YangLan, First Affiliated Hospital of Kunming Medical University
- Investigators
- Fang Ma,, professor of nursing, Principal investigator, First Affiliated Hospital of Kunming Medical UniversityFang Ma, professor of nursing, Principal investigator, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385209
- Sponsor's protocol ID
- 2025L393
- Other IDs
- 72364022
- Acronym
- CHD-HomeCare
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of pediatric and family health data, individual participant data will not be shared publicly to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Application of a Home Care Mini-Program for Children With Congenital Heart Disease After Discharge: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07385209
- Acronym / sponsor ID
- CHD-HomeCare / 2025L393
- Conditions
- Congenital Heart Disease
- Keywords
- home care, mobile health, postoperative rehabilitation, caregiver support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- ruijie YangLanUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
This is a single-blind, randomized controlled trial aimed at evaluating the effectiveness of a family-centered, WeChat-based home care mini-program for children after congenital heart disease (CHD) surgery. Given the chronic nature of post-operative CHD management and the significant stress placed on families, this study shifts from a deficit-based to a strengths-based perspective, guided by the Double ABC-X model. Children (≤12 years old) who have undergone CHD surgery and their primary caregivers will be recruited. Participants will be randomly assigned to either the intervention group, which uses the mini-program for health education, peer support, and physiological monitoring, or the control group, which receives routine telephone follow-up. The primary outcomes are family health (measured by the Family Health Scale), family stress, and the quality of life for both the child and caregivers. Secondary outcomes include physiological parameters such as the 6-minute walk test distance. The study aims to provide evidence for a scalable digital health intervention to support long-term family adaptation and child recovery.
Detailed description
- Background and Rationale Congenital heart disease (CHD) is the most common birth defect globally, with a high prevalence in China. While surgical advances have significantly improved survival rates, CHD has transitioned into a chronic condition requiring long-term management. The post-discharge period places immense stress on families, affecting caregiver well-being, family functioning, and the child's recovery. Existing home care models often focus on the child's deficits or rely on resource-intensive methods (e.g., home visits). Guided by the Double ABC-X model of family adaptation, this study adopts a family strengths-based perspective. It aims to develop and test a digital, interactive home care mini-program designed to support family resources, promote positive adaptation, and improve health outcomes after CHD surgery.
- Study Objectives Primary Objective: To evaluate the effectiveness of a family-centered, WeChat-based home care mini-program on improving family health in households with children after CHD surgery. Secondary Objectives: To assess the program's impact on: 1) reducing family stress, 2) enhancing the quality of life of both the child and primary caregivers, and 3) improving the child's physiological recovery indicators.
- Study Design This is a prospective, two-arm, parallel-group, assessor-blinded, randomized controlled trial (RCT). Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
- Participants, Setting, and Timeline Participants: Families (the child who underwent surgery and their primary caregiver/parent) of children (≤12 years old) with CHD after surgical intervention. Setting: Recruitment and baseline assessment will be conducted at a tertiary hospital in Yunnan Province, China. The intervention and follow-up will be home-based. Sample Size: 210 families (105 per group), calculated with 80% power, a significance level of 0.05, an effect size (δ/σ) of 0.5, and accounting for 20% attrition. Timeline: Study Start Date (first enrollment): December 2025. Primary Completion Date (last participant's final data collection for primary outcome): December 2026. Study Completion Date: January 2027.
- Interventions Intervention Group: Will receive access to the "CHD Postoperative Home Care" WeChat mini-program in addition to routine care. The mini-program includes three core modules: Education Module: Provides multimedia (text, images, video) health information on post-operative care, nutrition, medication, activity guidance, and complication monitoring. Interactive Support Module: Features a secure peer-support community for sharing experiences (digital narrative therapy) and a direct communication channel for families to consult the healthcare team. Monitoring \& Alert Module: Allows families to log and submit key health data (e.g., weight, symptoms). The system includes automated alerts for concerning values and prompts for scheduled follow-up assessments. The research team will remotely monitor this data and initiate follow-up calls if alerts are triggered. Control Group: Will receive routine postoperative care, which includes standard discharge instructions and scheduled telephone follow-ups by hospital staff at 1, 3, and 6 months post-discharge.
- Outcome Measures and Assessment Timepoints Assessments will occur at baseline (T0, pre-discharge) and at 1 (T1), 3 (T2), and 6 (T3) months post-discharge. Primary Outcomes: Family Health: Measured by the Chinese version of the Family Health Scale (FHS). Family Stress: Measured by the Congenital Heart Disease Family Stressor Scale. Quality of Life of Caregivers: Measured by the 36-Item Short Form Health Survey (SF-36). Quality of Life of the Child: Measured by the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cardiac Module. Secondary Outcomes (Child Physiological Measures): Functional Capacity: 6-Minute Walk Test distance. Growth: Body weight. Cardiac Function: Heart rate and Left Ventricular Ejection Fraction (via echocardiogram).
- Randomization, Blinding, and Data Analysis Randomization: After baseline assessment, eligible families will be randomly assigned using computer-generated random numbers sealed in opaque envelopes. Blinding: Outcome assessors and data analysts will be blinded to group allocation. Due to the nature of the intervention, participants and intervention facilitators cannot be blinded. Statistical Analysis: Data will be analyzed using SPSS software. Baseline characteristics will be compared using t-tests, chi-square, or Mann-Whitney U tests. Primary and secondary outcomes will be analyzed using Linear Mixed Models (LMM) for repeated measures to examine group, time, and interaction effects.
- Ethical Considerations The study protocol has been submitted for approval to the Institutional Review Board of Kunming Medical University. Written informed consent will be obtained from all participating caregivers. The study will adhere to principles of confidentiality, beneficence, and the right to withdraw without penalty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Routine Care with Telephone Follow-upParticipants receiving the WeChat mini-program intervention. |
| Control Group | Active comparator | Device: Home Care WeChat Mini-ProgramParticipants receiving routine care with telephone follow-up. |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- - The child is ≤12 years old.
- The child has been diagnosed with congenital heart disease (CHD) and is scheduled for or has undergone corrective surgery.
- The child is in a stable medical condition (non-acute phase).
- At least one primary caregiver (parent or sibling >12 years old) of the child agrees to participate.
- The caregiver provides written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- - The child has severe developmental defects.
- The child has other major diseases that significantly affect quality of life.
- The caregiver has visual, hearing, or cognitive impairments that hinder communication.
- The caregiver has a diagnosed psychiatric disorder.
- The caregiver is unconscious or otherwise unable to provide consent.
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 |
|---|---|---|
| Home Care WeChat Mini-ProgramA family-centered WeChat mini-program providing health education, peer support, and remote monitoring for post-operative care. | Device | Control Group |
| Routine Care with Telephone Follow-upParticipants in this group will receive standard post-discharge care as per hospital protocol, which includes initial discharge education and scheduled telephone follow-ups by hospital staff at 1, 3, and 6 months post-discharge to assess the child's status and answer questions. | Other | Intervention Group |
Primary outcome
Family Health Score
Time frame: Change from Baseline at 6 months post-discharge
Score on the Chinese version of the Family Health Scale (FHS).
Family Stress Score
Time frame: Change from Baseline at 6 months post-discharge
Score on the Congenital Heart Disease Family Stressor Scale.
Child's Quality of Life Score
Time frame: Change from Baseline at 6 months post-discharge
Score on the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cardiac Module.
Caregiver's Quality of Life Score
Time frame: Change from Baseline at 6 months post-discharge
Score on the 36-Item Short Form Health Survey (SF-36).
2 secondary outcomes
Body Weight
Time frame: Measured at 1, 3, and 6 months post-discharge
Left Ventricular Ejection Fraction
Time frame: Measured at 6 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. Due to the sensitive nature of pediatric and family health data, individual participant data will not be shared publicly to protect participant confidentiality.
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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.
Fang Ma,, professor of nursing principal investigator
First Affiliated Hospital of Kunming Medical University
Fang Ma, professor of nursing principal investigator
First Affiliated Hospital of Kunming Medical 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 Home Care WeChat Mini-Program and Routine Care with Telephone Follow-up in people with Congenital Heart Disease, run by ruijie YangLan 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruijie YangLan, Graduate Student (+86-18887278258, 1052076436@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Health Score (time frame: Change from Baseline at 6 months post-discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.