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.

Study Overview

• Status: Recruiting
• Conditions: Cardiomyopathies; Stroke, Ischemic; Heart Failure NYHA Class II; Vascular Disease; Atrial Fibrillation (AF); Cardiovascular; Hypertension Resistant to Conventional Therapy
• Intervention / Treatment: Other: Intervention of prevention

• Study Type: Interventional
• Enrollment (Estimated): 157
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Gardette, Dr; Phone Number: +33491381245; Email: promotion.interne@ap-hm.fr

Study Locations

• France
  • Gap, France
    • Recruiting
    • Gap +/- 20 km
    • Contact: Julie Gardette, Dr; Phone Number: +33491381245; Email: promotion.interne@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multidisciplinary preventive action and questionnaries; A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops and questionnaries	Other: Intervention of prevention; A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops.
No Intervention: No intervention but questionnaries; Refuse the intervention and answers questionnaries about why

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate of intervention	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the impact of the intervention	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Vascular Diseases; Ischemic Stroke; Atrial Fibrillation; Cardiomyopathies
• Other Study ID Numbers: RCAPHM23_0482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No