Heart Defects, CongenitalNCT06719323
Long-term Effects of Family WISH Program for Adolescents With Congenital Heart Disease
A study testing Family Walking Instruction with Support by Heart (Family WISH) program and Comparison group in people with Heart Defects, Congenital, run by Chi-Wen Chen at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Family Walking Instruction with Support by Heart (Family WISH) program and Comparison group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2026to 31 Jul 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- being between 12 and 18 years old;
- having received a diagnosis of CHD by a physician before age 2;
- having received a diagnosis of CHD with New York Heart Association (NYHA) functional class I, II, or III;
- having parents or guardians who were able to communicate in Mandarin, and being able to communicate in Mandarin themselves;
- not having cognitive impairments, and;
- voluntarily signing informed consent forms.
Who cannot join
- undergoing heart transplant surgery within the past year;
- receiving cardiac catheterization intervention or open-heart surgery within the past 6 months;
- having CHD with NYHA functional class IV; and
- having other congenital diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
College of Nursing, National Yang Ming Chiao Tung University
Taipei, 112304
Ch-Wen Chen, PhD, 011-886-228267348, chiwenchen@nycu.edu.tw
About this study
The goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD).
Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.
Read more
Participants will:
- Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week.
- Keep a diary to record the frequency of their walks and any symptoms experienced.
- Complete questionnaires at baseline, and at 6, 12, and 24 weeks.
- Conditions
- Heart Defects, Congenital
- Being tested
- Family Walking Instruction with Support by Heart (Family WISH) program, Comparison group
- 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.
Family Walking Instruction with Support by Heart (Family WISH) programBehavioural
Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.
Comparison groupBehavioural
a family walking health education sheet received
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group: a 12-week Family WISH program |
| Comparison group | Sham comparator | Comparison group: a family walking health education sheet received Receives: Behavioral: Comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
frailty state
self-reported questionnaire completed
Measured: at baseline, and at 6, 12, and 24 weeks
Secondary outcomes (1)
quality of life and family functioning
self-reported questionnaires completed
Measured: at baseline, and at 6, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi-Wen Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chi-Wen Chen, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719323
- Sponsor's protocol ID
- 202401204RINC
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Family WISH Program for Adolescents With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06719323
- Acronym / sponsor ID
- 202401204RINC
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Chi-Wen ChenUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Dec 2024 (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 goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD).
Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.
Participants will:
- Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week.
- Keep a diary to record the frequency of their walks and any symptoms experienced.
- Complete questionnaires at baseline, and at 6, 12, and 24 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | –Experimental group: a 12-week Family WISH program |
| Comparison group | Sham comparator | Behavioral: Comparison groupComparison group: a family walking health education sheet received |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- being between 12 and 18 years old;
- having received a diagnosis of CHD by a physician before age 2;
- having received a diagnosis of CHD with New York Heart Association (NYHA) functional class I, II, or III;
- having parents or guardians who were able to communicate in Mandarin, and being able to communicate in Mandarin themselves;
- not having cognitive impairments, and;
Key exclusion criteria (4 listed)
- undergoing heart transplant surgery within the past year;
- receiving cardiac catheterization intervention or open-heart surgery within the past 6 months;
- having CHD with NYHA functional class IV; and
- having other congenital diseases
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 |
|---|---|---|
| Family Walking Instruction with Support by Heart (Family WISH) programResearchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program. | Behavioural | – |
| Comparison groupa family walking health education sheet received | Behavioural | Comparison group |
Primary outcome
frailty state
Time frame: at baseline, and at 6, 12, and 24 weeks
self-reported questionnaire completed
1 secondary outcome
quality of life and family functioning
Time frame: at baseline, and at 6, 12, and 24 weeks
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 12 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Walking Instruction with Support by Heart (Family WISH) program and Comparison group in people with Heart Defects, Congenital, run by Chi-Wen Chen at 1 site in Taiwan.
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 6 inclusion and 4 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 12 Jan 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 Chi-Wen Chen, PhD (011-886-228267348, chiwenchen@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frailty state (time frame: at baseline, and at 6, 12, and 24 weeks). 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 12 Jan 2026.