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.

NCT06646601 | Recruiting

• 1 other identifier: RCAPHM23_0482
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Disease; Cardiovascular; Atrial Fibrillation (AF); Heart Failure NYHA Class II; Cardiomyopathies; Stroke, Ischemic; Hypertension Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessing the impact of the intervention

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Multidisciplinary preventive action and questionnaries

EXPERIMENTAL

A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops and questionnaries

Other: Intervention of prevention

No intervention but questionnaries

NO INTERVENTION

Refuse the intervention and answers questionnaries about why

Interventions

Intervention of prevention OTHER

A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops.

Multidisciplinary preventive action and questionnaries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Gap +/- 20 km

Gap, France

RECRUITING

MeSH Terms

Conditions

Vascular Diseases; Atrial Fibrillation; Cardiomyopathies; Ischemic Stroke; Hypertension Resistant to Conventional Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Julie Gardette, Dr

CONTACT

+33491381245; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 17, 2024
• Study Start: April 9, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

FR (1)