Vascular DiseaseArTERRENCT06646601
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.
A study testing Intervention of prevention in people with Vascular Disease and Cardiovascular, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease, Cardiovascular, Atrial Fibrillation (AF)
- What is being tested?
- Intervention of prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gap +/- 20 km
Gap
Julie Gardette, Dr, +33491381245, promotion.interne@ap-hm.fr
About this study
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
- Being tested
- Intervention of prevention
- Medical subject headings
- Vascular Diseases, Atrial Fibrillation, Cardiomyopathies, Ischemic Stroke, Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention of preventionOther
A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary preventive action and questionnaries | Experimental | A 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops and questionnaries Receives: Other: Intervention of prevention |
| No intervention but questionnaries | No intervention | Refuse the intervention and answers questionnaries about why |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (1)
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.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start9 Apr 2024
- Primary completion31 Mar 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646601
- Sponsor's protocol ID
- RCAPHM23_0482
- Acronym
- ArTERRE
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06646601
- Acronym / sponsor ID
- ArTERRE / RCAPHM23_0482
- Conditions
- Vascular Disease, Cardiovascular, Atrial Fibrillation (AF), Heart Failure NYHA Class II, Cardiomyopathies, Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary preventive action and questionnaries | Experimental | Other: Intervention of preventionA 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops and questionnaries |
| No intervention but questionnaries | No intervention | –Refuse the intervention and answers questionnaries about why |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention of preventionA 6-month multidisciplinary preventive intervention for each patient: gardening, adapted physical activity, nutritional workshops. | Other | Multidisciplinary preventive action and questionnaries |
Primary outcome
Acceptance rate of intervention
Time frame: 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.
Identification of the obstacles and facilitators for intervention
Time frame: 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.
1 secondary outcome
Assessing the impact of the intervention
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention of prevention in people with Vascular Disease and Cardiovascular, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Gardette, Dr (+33491381245, promotion.interne@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance rate of intervention (time frame: From enrollment to the end of treatment at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.