- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01785498
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1H 8L1
- Children's Hospital of Eastern Ontario
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: Control Group
Receive standard clinical care and supports.
|
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실험적: Supplementary resources
Receive standard care and supports plus supplementary resources developed for the intervention.
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Clinical and educational resources for patients, their families and the professionals who care for them.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Family perception of clinical service
기간: Within 2 weeks of clinic visit
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Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.
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Within 2 weeks of clinic visit
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Pediatric Quality of Life Inventory (PedsQL)
기간: Within 2 weeks of clinic visit
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Within 2 weeks of clinic visit
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity
기간: 1 month after intervention completion
|
1 month after intervention completion
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기타 결과 측정
결과 측정 |
기간 |
---|---|
Change from Baseline in Multi-dimension anxiety scale for children
기간: 1 month after intervention completion
|
1 month after intervention completion
|
Change from Baseline in Pediatric Symptom Checklist
기간: 1 month after intervention completion
|
1 month after intervention completion
|
Change from Baseline in PedsQL Family Impact Module
기간: 1 month after intervention completion
|
1 month after intervention completion
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .