Congenital Heart DefectsReACHNCT01785498
Healthy Lifestyles for Children With Complex Heart Problems
A study testing Supplementary resources in people with Congenital Heart Defects and Inherited Cardiac Arrhythmias, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource development project. The goal of the project is to develop an implementation plan that would enable children with complex heart problems to lead healthy, active lives within their own community. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Congenital Heart Defects, Inherited Cardiac Arrhythmias, Cardiomyopathy
- What is being tested?
- Supplementary resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Oct 2013
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child with a heart condition requiring on-going follow up between 4 and 17 years of age or parent or healthcare provider of such a child
- able to verbally answer questions and express opinions in English or French
- able to provide informed consent or assent to participate
Who cannot join
- disability other than heart condition which significantly impacts physical activity participation or healthy lifestyle habits
Trial locations and contacts
1 site in 1 country.
About this study
Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource development project. The goal of the project is to develop an implementation plan that would enable children with complex heart problems to lead healthy, active lives within their own community. The primary goal of the project is to promote physical activity, because the physical and mental health benefits of activity are very important for these children. Children with complex heart problems have a higher risk for obesity, diabetes, acquired heart disease and mental health problems than their healthy peers. The physical health benefits of physical activity are well known, but physical activity is also key for children's mental health. Physical activity enables children to socialize with peers and create bonds and friendships. Physical activity participation also directly elevates mood through the release of brain chemicals. Children with complex heart problems are also known to experience fear and anxiety related to physical activity. This project will also develop strategies to promote healthy eating and the prevention of physical activity-related injuries to these children and their families. Children with complex heart problems are at higher risk of overweight and obesity and face unique injury risks related to pacemakers or their medications.
Extensive consultations with families and caregivers have identified needed supports for physical activity lifestyles, mental health, healthy eating and injury prevention for these children. The goal of the interviews was to understand the positive and negative influences on physical activity and healthy lifestyles for these children. Analyses of the interview content was used to develop a detailed, step-by-step implementation plan to provide the supports necessary for children with complex heart problems to lead active, healthy lives in their own community, with their family and friends. The implementation plan specifies changes to family education and counselling resources, clinical care routines, and communication among professionals and families.
The clinical trial will evaluate the impact of implementing the family supports and changes to practice previously developed. Surveys will be completed by families attending the cardiac clinic before and after the changes to practice and additional resources are made available. Interviews will be utilized to gather additional feedback from professionals and families that receive counselling utilizing the supplementary materials.
- Being tested
- Supplementary resources
- Keywords
- children, quality of life, physical activity, healthy lifestyle
- Medical subject headings
- Heart Defects, Congenital, Cardiomyopathies, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementary resourcesBehavioural
Clinical and educational resources for patients, their families and the professionals who care for them.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Receive standard clinical care and supports. |
| Supplementary resources | Experimental | Receive standard care and supports plus supplementary resources developed for the intervention. Receives: Behavioral: Supplementary resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family perception of clinical service
Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.
Measured: Within 2 weeks of clinic visit
Pediatric Quality of Life Inventory (PedsQL)
Measured: Within 2 weeks of clinic visit
Secondary outcomes (1)
Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity
Measured: 1 month after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Variety Village, Heart and Stroke Foundation of Ontario, City of Toronto Parks, Forestry and Recreation
- Responsible party
- Principal investigator, Dr. Pat Longmuir, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785498
- Sponsor's protocol ID
- REB12/04X
- Other IDs
- 2012-06-1-4460033
- Acronym
- ReACH
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2013
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifestyles for Children With Complex Heart Problems
- ClinicalTrials.gov ID
- NCT01785498
- Acronym / sponsor ID
- ReACH / REB12/04X
- Keywords
- children, quality of life, physical activity, healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Variety Village, Heart and Stroke Foundation of Ontario, City of Toronto Parks, Forestry and Recreation
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Feb 2013 (estimated)
- 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.
Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource development project. The goal of the project is to develop an implementation plan that would enable children with complex heart problems to lead healthy, active lives within their own community. The primary goal of the project is to promote physical activity, because the physical and mental health benefits of activity are very important for these children. Children with complex heart problems have a higher risk for obesity, diabetes, acquired heart disease and mental health problems than their healthy peers. The physical health benefits of physical activity are well known, but physical activity is also key for children's mental health. Physical activity enables children to socialize with peers and create bonds and friendships. Physical activity participation also directly elevates mood through the release of brain chemicals. Children with complex heart problems are also known to experience fear and anxiety related to physical activity. This project will also develop strategies to promote healthy eating and the prevention of physical activity-related injuries to these children and their families. Children with complex heart problems are at higher risk of overweight and obesity and face unique injury risks related to pacemakers or their medications.
Extensive consultations with families and caregivers have identified needed supports for physical activity lifestyles, mental health, healthy eating and injury prevention for these children. The goal of the interviews was to understand the positive and negative influences on physical activity and healthy lifestyles for these children. Analyses of the interview content was used to develop a detailed, step-by-step implementation plan to provide the supports necessary for children with complex heart problems to lead active, healthy lives in their own community, with their family and friends. The implementation plan specifies changes to family education and counselling resources, clinical care routines, and communication among professionals and families.
The clinical trial will evaluate the impact of implementing the family supports and changes to practice previously developed. Surveys will be completed by families attending the cardiac clinic before and after the changes to practice and additional resources are made available. Interviews will be utilized to gather additional feedback from professionals and families that receive counselling utilizing the supplementary materials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Receive standard clinical care and supports. |
| Supplementary resources | Experimental | Behavioral: Supplementary resourcesReceive standard care and supports plus supplementary resources developed for the intervention. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child with a heart condition requiring on-going follow up between 4 and 17 years of age or parent or healthcare provider of such a child
- able to verbally answer questions and express opinions in English or French
- able to provide informed consent or assent to participate
Key exclusion criteria (1 listed)
- disability other than heart condition which significantly impacts physical activity participation or healthy lifestyle habits
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 |
|---|---|---|
| Supplementary resourcesClinical and educational resources for patients, their families and the professionals who care for them. | Behavioural | Supplementary resources |
Primary outcome
Family perception of clinical service
Time frame: Within 2 weeks of clinic visit
Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Within 2 weeks of clinic visit
1 secondary outcome
Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity
Time frame: 1 month after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementary resources in people with Congenital Heart Defects and Inherited Cardiac Arrhythmias, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2015. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family perception of clinical service (time frame: Within 2 weeks of clinic visit). The study lists 2 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 12 Feb 2015.