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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Gap、フランス
- Gap +/- 20 km
-
-
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:
- 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.
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：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：No intervention but questionnaries
Refuse the intervention and answers questionnaries about why |
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 |
|---|---|---|
|
Acceptance rate of intervention
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessing the impact of the intervention
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。