Healthy Lifestyles for Children With Complex Heart Problems (ReACH)
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Ottawa、Ontario、カナダ、K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- disability other than heart condition which significantly impacts physical activity participation or healthy lifestyle habits
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし:Control Group
Receive standard clinical care and supports.
|
|
|
実験的:Supplementary resources
Receive standard care and supports plus supplementary resources developed for the intervention.
|
Clinical and educational resources for patients, their families and the professionals who care for them.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Family perception of clinical service
時間枠:Within 2 weeks of clinic visit
|
Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.
|
Within 2 weeks of clinic visit
|
|
Pediatric Quality of Life Inventory (PedsQL)
時間枠:Within 2 weeks of clinic visit
|
Within 2 weeks of clinic visit
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity
時間枠:1 month after intervention completion
|
1 month after intervention completion
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline in Multi-dimension anxiety scale for children
時間枠:1 month after intervention completion
|
1 month after intervention completion
|
|
Change from Baseline in Pediatric Symptom Checklist
時間枠:1 month after intervention completion
|
1 month after intervention completion
|
|
Change from Baseline in PedsQL Family Impact Module
時間枠:1 month after intervention completion
|
1 month after intervention completion
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。