- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06646601
A Preventive, Multidisciplinary Primary Care Intervention Organized Around a Therapeutic Garden: Acceptability to Patients Suffering From Cardio-neurovascular Pathology and to Those Involved in the Action. (ArTERRE)
A preventive, multidisciplinary primary care intervention organized around a therapeutic garden: Acceptability to patients suffering from cardio-neurovascular pathology and to those involved in the action.
연구 개요
상태
개입 / 치료
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Gap, 프랑스
- Gap +/- 20 km
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age > 18 years old;
- living in the vicinity (+-20 km) of Gap, Laragne-Montéglin, Veynes and Clermont-Ferrand;
- having been invited to take part in the intervention by the caregivers of the medical structures
- suffering from an ALD based on CNAM medical criteria (stroke, AOMI, rhythm disorders, valvular heart disease, congenital heart disease, stage I and II heart failure), severe hypertension, chronic coronary disease)
Exclusion Criteria:
- heart failure based on CNAM medical criteria (ALD n°5) stage III and IV according to NYHA classification ;
- with a contraindication to physical activity ;
- living in an institution;
- unable to walk more than 100 m independently;
- Alzheimer's disease or other dementias based on CNAM medical criteria ;
- with an unlabelled cognitive impairment limiting comprehension.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Multidisciplinary preventive action and questionnaries
A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops and questionnaries |
A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops. |
|
간섭 없음: No intervention but questionnaries
Refuse the intervention and answers questionnaries about why |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acceptance rate of intervention
기간: From enrollment to the end of treatment at 6 months
|
Assessing the acceptability of a multidisciplinary intervention combining gardening activities, APA and nutrition workshops, organized around a therapeutic garden, by patients suffering from cardio-neurovascular pathologies and the interveners of the action. |
From enrollment to the end of treatment at 6 months
|
|
Identification of the obstacles and facilitators for intervention
기간: From enrollment to the end of treatment at 6 months
|
Identify the obstacles and factors facilitating patients' initial adhesion to and commitment to the scheme, and those influencing the implementation of the action by those involved, i.e. the facilitators and caregivers involved. |
From enrollment to the end of treatment at 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assessing the impact of the intervention
기간: From enrollment to the end of treatment at 6 months
|
Assess the impact of the intervention on quality of life, adoption of new lifestyle habits (PA and Mediterranean diet), depressive symptoms and physical performance, taking into account any adverse effects. |
From enrollment to the end of treatment at 6 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .