Heart Defects, CongenitalNCT07055334
Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation
An observational study of Heart Defects, Congenital and Rehabilitation, run by Wei XIA, PhD at 1 site in China.
Trial summary
This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital, Rehabilitation, Preschool Child
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 31 Dec 2026
- Phase
- Observational
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study includes three groups. For children with congenital heart disease after surgery, inclusion criteria are age 3 to 7, one-time corrective open-heart surgery in the research unit, and ability to communicate in Chinese. Exclusions are arrhythmia after surgery, other diseases unsuitable for exercise, heart function class IV, and perioperative disorders. For caregivers, must be main caregiver, volunteer, spend most time caring, and communicate in Chinese. Exclusions are those who give up treatment, are paid caregivers, have cognitive impairment or mental illness, cannot express feelings, have contradictions with child, or cannot use electronic devices. For medical professionals, must hold license and have at least 5 years of related practice. Exclusions are non-frontline staff or those absent in recent year.
Who may be able to join
- Age 3 to 7 years
- Clinical diagnosis of congenital heart disease
- Underwent a single open-heart surgical correction under direct vision at the study site
- Ability to communicate in Chinese
- Primary caregiver who voluntarily provides care
- Caregiver who spends the most time with the child
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- Ability to communicate in Chinese
- Licensed healthcare professionals, including physicians, nurses, dietitians, physical therapists, or psychological counselors
- At least 5 years of professional experience in congenital heart disease care, rehabilitation, or education
Who cannot join
- Postoperative arrhythmia
- Comorbid neurological, respiratory, or other systemic diseases
- Deemed unsuitable for exercise by a physician
- Cardiac function classified as NYHA Class IV
- Intellectual, language, or motor impairments resulting from perioperative complications or other causes
- Caregivers of Children With Congenital Heart Disease After Surgery
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- Caregivers of children who voluntarily discontinued treatment before completion
- Paid or professional caregivers
- Diagnosed cognitive impairment or mental illness
- Inability to communicate effectively through spoken language
- Presence of serious conflict or instability in the caregiver-child relationship
- Inability to independently operate or use smart electronic devices and the internet
- Medical Professionals Involved in Congenital Heart Disease Care
- Not currently engaged in frontline clinical work
- Not engaged in clinical work within the past year due to leave, study, or reassignment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.
- Conditions
- Heart Defects, Congenital, Rehabilitation, Preschool Child, Qualitative Research, Caregivers, Medical Staff, Hospital
- Keywords
- congenital heart disease, home-based cardiac rehabilitation, Primary caregiver, qualitative research, preschool child
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus
The home rehabilitation scheme will be developed using a two-round Delphi method with a multidisciplinary expert panel. Each proposed module will be rated by experts for its relevance, feasibility, and clarity. Components reaching ≥75% agreement (rated as "agree" or "strongly agree") will be considered finalized. The outcome will be reported as the number and percentage of components finalized out of all proposed components.
Measured: 12 months (from initiation to completion of scheme development)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Xia Wei, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055334
- Sponsor's protocol ID
- LSLL2024-801
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation
- ClinicalTrials.gov ID
- NCT07055334
- Acronym / sponsor ID
- LSLL2024-801
- Conditions
- Heart Defects, Congenital, Rehabilitation, Preschool Child, Qualitative Research, Caregivers, Medical Staff, Hospital
- Keywords
- congenital heart disease, home-based cardiac rehabilitation, Primary caregiver, qualitative research, preschool child
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jul 2025 (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 part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes three groups. For children with congenital heart disease after surgery, inclusion criteria are age 3 to 7, one-time corrective open-heart surgery in the research unit, and ability to communicate in Chinese. Exclusions are arrhythmia after surgery, other diseases unsuitable for exercise, heart function class IV, and perioperative disorders. For caregivers, must be main caregiver, volunteer, spend most time caring, and communicate in Chinese. Exclusions are those who give up treatment, are paid caregivers, have cognitive impairment or mental illness, cannot express feelings, have contradictions with child, or cannot use electronic devices. For medical professionals, must hold license and have at least 5 years of related practice. Exclusions are non-frontline staff or those absent in recent year.
Key inclusion criteria (9 listed)
- Age 3 to 7 years
- Clinical diagnosis of congenital heart disease
- Underwent a single open-heart surgical correction under direct vision at the study site
- Ability to communicate in Chinese
- Primary caregiver who voluntarily provides care
Key exclusion criteria (15 listed)
- Postoperative arrhythmia
- Comorbid neurological, respiratory, or other systemic diseases
- Deemed unsuitable for exercise by a physician
- Cardiac function classified as NYHA Class IV
- Intellectual, language, or motor impairments resulting from perioperative complications or other causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus
Time frame: 12 months (from initiation to completion of scheme development)
The home rehabilitation scheme will be developed using a two-round Delphi method with a multidisciplinary expert panel. Each proposed module will be rated by experts for its relevance, feasibility, and clarity. Components reaching ≥75% agreement (rated as "agree" or "strongly agree") will be considered finalized. The outcome will be reported as the number and percentage of components finalized out of all proposed components.
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 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Xia Wei, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital and Rehabilitation, run by Wei XIA, PhD 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 9 inclusion and 15 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 8 Jul 2025. 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 Xia Wei, PhD (+8618823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus (time frame: 12 months (from initiation to completion of scheme development)). 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 8 Jul 2025.