Cardiovascular DiseasePR1MaCNCT01319656
Integration of Chronic Disease Rehabilitation Services Into Primary Care
A study testing Support, management, educational, counselling, follow-up in people with Cardiovascular Disease and Heart Failure, run by Martin Fortin at 1 site in Canada.
Trial summary
The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently integrate rehabilitation services into primary care settings, which would be the reference point in the health care system for people with Chronic diseases (CD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Support, management, educational, counselling, follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- present at least one of the following conditions: type 2 diabetes, CVD, heart failure, risk factors (smoking, obesity, hyperlipidemia, glucose intolerance, and metabolic syndrome), COPD or asthma.
- have the potential for rehabilitation
Who cannot join
- serious cognitive problems
Trial locations and contacts
1 site in 1 country.
Canada1 site
CSSS de Chicoutimi, Unité de médecine de famille
Chicoutimi, Quebec, G7H 5H6
About this study
Official title: Adaptation, Implementation and Evaluation of an Intervention Involving the Integration of Chronic Disease Rehabilitation Services Into Primary Care
The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently integrate rehabilitation services into primary care settings, which would be the reference point in the health care system for people with Chronic diseases (CD). More specifically, the intervention will aim to: (1) clinically operationalize the mechanisms and tools necessary for delivery of integrated CD services, promoting continuity of care in response to the needs expressed by stakeholders; (2) implement and deploy rehabilitation services adapted to the realities of various clinical primary care settings and develop tools to ensure the sustainability of interventions beyond the rehabilitation period; and (3) support clinical primary care teams in the acquisition and maintenance of evidence-based practices for the targeted CDs.
Read the detailed description
Since 2001, professionals in the Saguenay-Lac-Saint-Jean (SLSJ) region in Quebec province, Canada, have been mobilized to deal with the challenges of CD management by the introduction of the SLSJ Trajectory of Integrated Rehabilitation Services for CD (Trajectoire des services de réadaptation intégrés pour MC du SLSJ), hereafter referred to as the "Trajectoire." This Trajectoire, deployed across the region, constitutes a solid network of rehabilitation services, due as much to the resources granted to it and its evidence-based approach as to the appreciation that patients and professionals within the regional health system have for it. The changes and new directions that have taken place in recent years suggest it is time to improve this Trajectoire by promoting greater integration with primary care services to improve accessibility, the complementarity of services and better post-rehabilitation continuity. The proposed intervention involves the adaptation and integration of rehabilitation services under the Trajectoire's leadership within primary care settings (FMG or medical clinics), so that collaborative work routines are developed and implemented directly at the main place of contact with health services for people with a CD. The intervention will be implemented at the CSSSs in Chicoutimi and Jonquière. This logic model was developed in collaboration with researchers, clinicians and decision-makers involved in this application and discussed at meetings for the preparation of this application. The model's first component (objective 1) will consist of a consultation with stakeholders (primary care professionals, Trajectoire professionals) by sharing information about the current range of services. In each area, the consultation will include a needs evaluation and a reflection on the Trajectoire's services that can be adapted for targeted clients. As each clinic where an intervention will be deployed has its own mode of operation and clientele characteristics, the clinical intervention will be specifically adapted to these considerations and prepared in collaboration with each clinical setting to ensure a range of services that meets the expressed needs.
The second component (objective 2) will be to implement and deploy a range of concerted interdisciplinary services adapted to the client services and professional resources already in place. Services that do not require specialized equipment or adapted premises (a gym, for example) can be integrated, including educational/teaching services (self-care, support to stop smoking, nutrition, etc.). In medical clinics currently not offering these services, the addition will be net, while in those that already rely on the services of nurse practitioners (FMG), the addition of these services will complement existing services. During this period, various mechanisms and clinical information sharing tools will be implemented jointly by professionals. The third component will be to implement a support mechanism and ongoing evaluation within the clinical setting to ensure harmonious integration. If necessary, training workshops will be provided to implement or maintain evidence-based practices and to plan longer-term follow-up of clientele and continuity of interventions.
The intervention: (a) will be educational in nature, patient-centred and based on the Trajectoire; (b) will last at least three months and involve at least three meetings; (c) may include meetings with small patient groups or the involvement of a close relative of the patient (spouse or primary caregiver); (d) will be carried out based on a referral from the primary care team according to defined criteria; (e) will allow an exchange with the primary care team and will be integrated into the primary care medical records; (f) will provide for a transfer of responsibility to the primary care team to ensure ongoing long-term follow-up.
- Conditions
- Cardiovascular Disease, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Diabetes
- Being tested
- Support, management, educational, counselling, follow-up
- Keywords
- Chronic diseases, Primary care, Rehabilitation, Chronic Care Model, Patient centered medical home
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Pulmonary Disease, Chronic Obstructive, Asthma, Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support, management, educational, counselling, follow-upBehavioural
Also called dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance
The project offers a range of activities (educational, counselling, follow-up) by several professionals. The varied range of services is spread out over six months and may include individual or group meetings with professionals. Informational documents and follow-up tools are provided to patients based on their condition, to facilitate the acquisition and maintenance of knowledge, self-management, and changes in risk behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Intervention group(n = 163) Receives: Behavioral: Support, management, educational, counselling, follow-up |
| Group B | Active comparator | Delayed intervention (n = 163) Receives: Behavioral: Support, management, educational, counselling, follow-up |
| Group C | No intervention | No intervention group (n = 163) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of effects
Short term:
- Self-Efficacy Managing Chronic Disease scale: SEMCD
- Health Education Impact questionnaire: heiQ
Medium term:
- Risk factors
- Functional health status/quality of life: SF12
- Psychological well being: K6
Other:
- Socio-demographic: SD
- comorbidity
- co-intervention (CI)
Visites:
- 1:(week:- 2) : Group A and B: DBMA; SD; SF12; K6; SEMCD, heiQ
- 2a:(week:0) : Group A, (week:12) for Group B: SEMCD, heiQ; CI
- 2b, 2c: (weeks:4, 8) : Group A: CI
- 3:(weeks:12) : Group A: SEMCD, heiQ; CI
- 4:(weeks:52) : Group A: SF12, K6; SEMCD, heiQ; CI
Measured: T1: Initial evaluation; T2: after three months; T3: one year after T1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Fortin
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Fonds de la Recherche en Santé du Québec, Ministere de la Sante et des Services Sociaux, Centre de santé et de services sociaux de Chicoutimi, Centre de santé et de services sociaux de Jonquière
- Responsible party
- Sponsor-investigator, Martin Fortin, Université de Sherbrooke
- Investigators
- Martin Fortin, MD, M.Sc., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319656
- Sponsor's protocol ID
- FRSQ-24423
- Acronym
- PR1MaC
- Status last verified
- Sep 2021
- First submitted
- 21 Mar 2011
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
PubMed 11816692Tsai AC, Morton SC, Mangione CM, Keeler EB. A meta-analysis of interventions to improve care for chronic illnesses. Am J Manag Care. 2005 Aug;11(8):478-88.
PubMed 16095434Dennis SM, Zwar N, Griffiths R, Roland M, Hasan I, Powell Davies G, Harris M. Chronic disease management in primary care: from evidence to policy. Med J Aust. 2008 Apr 21;188(S8):S53-6. doi: 10.5694/j.1326-5377.2008.tb01745.x.
PubMed 18429737Rothman AA, Wagner EH. Chronic illness management: what is the role of primary care? Ann Intern Med. 2003 Feb 4;138(3):256-61. doi: 10.7326/0003-4819-138-3-200302040-00034.
PubMed 12558376Chreim S, Williams BE, Janz L, Dastmalchian A. Change agency in a primary health care context: the case of distributed leadership. Health Care Manage Rev. 2010 Apr-Jun;35(2):187-99. doi: 10.1097/HMR.0b013e3181c8b1f8.
PubMed 20234224Hogg W, Lemelin J, Moroz I, Soto E, Russell G. Improving prevention in primary care: Evaluating the sustainability of outreach facilitation. Can Fam Physician. 2008 May;54(5):712-20.
PubMed 18474705Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
PubMed 16263889Peytremann-Bridevaux I, Staeger P, Bridevaux PO, Ghali WA, Burnand B. Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. Am J Med. 2008 May;121(5):433-443.e4. doi: 10.1016/j.amjmed.2008.02.009.
PubMed 18456040Gibson PG, Powell H, Coughlan J, Wilson AJ, Abramson M, Haywood P, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2003;(1):CD001117. doi: 10.1002/14651858.CD001117.
PubMed 12535399Ellis SE, Speroff T, Dittus RS, Brown A, Pichert JW, Elasy TA. Diabetes patient education: a meta-analysis and meta-regression. Patient Educ Couns. 2004 Jan;52(1):97-105. doi: 10.1016/s0738-3991(03)00016-8.
PubMed 14729296Gary TL, Genkinger JM, Guallar E, Peyrot M, Brancati FL. Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes. Diabetes Educ. 2003 May-Jun;29(3):488-501. doi: 10.1177/014572170302900313.
PubMed 12854339Smith SM, Allwright S, O'Dowd T. Effectiveness of shared care across the interface between primary and specialty care in chronic disease management. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004910. doi: 10.1002/14651858.CD004910.pub2.
PubMed 17636778Oelke ND, Cunning L, Andrews K, Martin D, MacKay A, Kuschminder K, Congdon V. Organizing care across the continuum: primary care, specialty services, acute and long-term care. Healthc Q. 2009;13 Spec No:75-9. doi: 10.12927/hcq.2009.21102.
PubMed 20057254Delon S, Mackinnon B; Alberta Health CDM Advisory Committee. Alberta's systems approach to chronic disease management and prevention utilizing the expanded chronic care model. Healthc Q. 2009;13 Spec No:98-104. doi: 10.12927/hcq.2009.21106.
PubMed 20057258Walsh K, Duke J, Foureur M, Macdonald L. Designing an effective evaluation plan: a tool for understanding and planning evaluations for complex nursing contexts. Contemp Nurse. 2007 May-Jun;25(1-2):136-45. doi: 10.5172/conu.2007.25.1-2.136.
PubMed 17622997
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation, Implementation and Evaluation of an Intervention Involving the Integration of Chronic Disease Rehabilitation Services Into Primary Care
- ClinicalTrials.gov ID
- NCT01319656
- Acronym / sponsor ID
- PR1MaC / FRSQ-24423
- Conditions
- Cardiovascular Disease, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Diabetes
- Keywords
- Chronic diseases, Primary care, Rehabilitation, Chronic Care Model, Patient centered medical home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Martin FortinUniversity, hospital or other
- Collaborators
- Pfizer, Fonds de la Recherche en Santé du Québec, Ministere de la Sante et des Services Sociaux, Centre de santé et de services sociaux de Chicoutimi, Centre de santé et de services sociaux de Jonquière
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Mar 2011 (estimated)
- 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.
The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently integrate rehabilitation services into primary care settings, which would be the reference point in the health care system for people with Chronic diseases (CD). More specifically, the intervention will aim to: (1) clinically operationalize the mechanisms and tools necessary for delivery of integrated CD services, promoting continuity of care in response to the needs expressed by stakeholders; (2) implement and deploy rehabilitation services adapted to the realities of various clinical primary care settings and develop tools to ensure the sustainability of interventions beyond the rehabilitation period; and (3) support clinical primary care teams in the acquisition and maintenance of evidence-based practices for the targeted CDs.
Detailed description
Since 2001, professionals in the Saguenay-Lac-Saint-Jean (SLSJ) region in Quebec province, Canada, have been mobilized to deal with the challenges of CD management by the introduction of the SLSJ Trajectory of Integrated Rehabilitation Services for CD (Trajectoire des services de réadaptation intégrés pour MC du SLSJ), hereafter referred to as the "Trajectoire." This Trajectoire, deployed across the region, constitutes a solid network of rehabilitation services, due as much to the resources granted to it and its evidence-based approach as to the appreciation that patients and professionals within the regional health system have for it. The changes and new directions that have taken place in recent years suggest it is time to improve this Trajectoire by promoting greater integration with primary care services to improve accessibility, the complementarity of services and better post-rehabilitation continuity. The proposed intervention involves the adaptation and integration of rehabilitation services under the Trajectoire's leadership within primary care settings (FMG or medical clinics), so that collaborative work routines are developed and implemented directly at the main place of contact with health services for people with a CD. The intervention will be implemented at the CSSSs in Chicoutimi and Jonquière. This logic model was developed in collaboration with researchers, clinicians and decision-makers involved in this application and discussed at meetings for the preparation of this application. The model's first component (objective 1) will consist of a consultation with stakeholders (primary care professionals, Trajectoire professionals) by sharing information about the current range of services. In each area, the consultation will include a needs evaluation and a reflection on the Trajectoire's services that can be adapted for targeted clients. As each clinic where an intervention will be deployed has its own mode of operation and clientele characteristics, the clinical intervention will be specifically adapted to these considerations and prepared in collaboration with each clinical setting to ensure a range of services that meets the expressed needs.
The second component (objective 2) will be to implement and deploy a range of concerted interdisciplinary services adapted to the client services and professional resources already in place. Services that do not require specialized equipment or adapted premises (a gym, for example) can be integrated, including educational/teaching services (self-care, support to stop smoking, nutrition, etc.). In medical clinics currently not offering these services, the addition will be net, while in those that already rely on the services of nurse practitioners (FMG), the addition of these services will complement existing services. During this period, various mechanisms and clinical information sharing tools will be implemented jointly by professionals. The third component will be to implement a support mechanism and ongoing evaluation within the clinical setting to ensure harmonious integration. If necessary, training workshops will be provided to implement or maintain evidence-based practices and to plan longer-term follow-up of clientele and continuity of interventions.
The intervention: (a) will be educational in nature, patient-centred and based on the Trajectoire; (b) will last at least three months and involve at least three meetings; (c) may include meetings with small patient groups or the involvement of a close relative of the patient (spouse or primary caregiver); (d) will be carried out based on a referral from the primary care team according to defined criteria; (e) will allow an exchange with the primary care team and will be integrated into the primary care medical records; (f) will provide for a transfer of responsibility to the primary care team to ensure ongoing long-term follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Support, management, educational, counselling, follow-upIntervention group(n = 163) |
| Group B | Active comparator | Behavioral: Support, management, educational, counselling, follow-upDelayed intervention (n = 163) |
| Group C | No intervention | –No intervention group (n = 163) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- present at least one of the following conditions: type 2 diabetes, CVD, heart failure, risk factors (smoking, obesity, hyperlipidemia, glucose intolerance, and metabolic syndrome), COPD or asthma.
- have the potential for rehabilitation
Key exclusion criteria (1 listed)
- serious cognitive problems
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 |
|---|---|---|
| Support, management, educational, counselling, follow-upAlso: dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug complianceThe project offers a range of activities (educational, counselling, follow-up) by several professionals. The varied range of services is spread out over six months and may include individual or group meetings with professionals. Informational documents and follow-up tools are provided to patients based on their condition, to facilitate the acquisition and maintenance of knowledge, self-management, and changes in risk behaviour. | Behavioural | Group A, Group B |
Primary outcome
Evaluation of effects
Time frame: T1: Initial evaluation; T2: after three months; T3: one year after T1
Short term: * Self-Efficacy Managing Chronic Disease scale: SEMCD * Health Education Impact questionnaire: heiQ Medium term: * Risk factors * Functional health status/quality of life: SF12 * Psychological well being: K6 Other: * Socio-demographic: SD * comorbidity * co-intervention (CI) Visites: * 1:(week:- 2) : Group A and B: DBMA; SD; SF12; K6; SEMCD, heiQ * 2a:(week:0) : Group A, (week:12) for Group B: SEMCD, heiQ; CI * 2b, 2c: (weeks:4, 8) : Group A: CI * 3:(weeks:12) : Group A: SEMCD, heiQ; CI * 4:(weeks:52) : Group A: SF12, K6; SEMCD, heiQ; CI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 11816692Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
- Background: PubMed 16095434Tsai AC, Morton SC, Mangione CM, Keeler EB. A meta-analysis of interventions to improve care for chronic illnesses. Am J Manag Care. 2005 Aug;11(8):478-88.
- Background: PubMed 18429737Dennis SM, Zwar N, Griffiths R, Roland M, Hasan I, Powell Davies G, Harris M. Chronic disease management in primary care: from evidence to policy. Med J Aust. 2008 Apr 21;188(S8):S53-6. doi: 10.5694/j.1326-5377.2008.tb01745.x.
- Background: PubMed 12558376Rothman AA, Wagner EH. Chronic illness management: what is the role of primary care? Ann Intern Med. 2003 Feb 4;138(3):256-61. doi: 10.7326/0003-4819-138-3-200302040-00034.
- Background: PubMed 20234224Chreim S, Williams BE, Janz L, Dastmalchian A. Change agency in a primary health care context: the case of distributed leadership. Health Care Manage Rev. 2010 Apr-Jun;35(2):187-99. doi: 10.1097/HMR.0b013e3181c8b1f8.
- Background: PubMed 18474705Hogg W, Lemelin J, Moroz I, Soto E, Russell G. Improving prevention in primary care: Evaluating the sustainability of outreach facilitation. Can Fam Physician. 2008 May;54(5):712-20.
- Background: PubMed 16263889Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
- Background: PubMed 18456040Peytremann-Bridevaux I, Staeger P, Bridevaux PO, Ghali WA, Burnand B. Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. Am J Med. 2008 May;121(5):433-443.e4. doi: 10.1016/j.amjmed.2008.02.009.
- Background: PubMed 12535399Gibson PG, Powell H, Coughlan J, Wilson AJ, Abramson M, Haywood P, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2003;(1):CD001117. doi: 10.1002/14651858.CD001117.
- Background: PubMed 14729296Ellis SE, Speroff T, Dittus RS, Brown A, Pichert JW, Elasy TA. Diabetes patient education: a meta-analysis and meta-regression. Patient Educ Couns. 2004 Jan;52(1):97-105. doi: 10.1016/s0738-3991(03)00016-8.
- Background: PubMed 12854339Gary TL, Genkinger JM, Guallar E, Peyrot M, Brancati FL. Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes. Diabetes Educ. 2003 May-Jun;29(3):488-501. doi: 10.1177/014572170302900313.
- Background: PubMed 17636778Smith SM, Allwright S, O'Dowd T. Effectiveness of shared care across the interface between primary and specialty care in chronic disease management. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004910. doi: 10.1002/14651858.CD004910.pub2.
- CIHR Applied Research Chair - Health Services and Policy Research on Chronic Diseases in Primary CareLink provided by the sponsor.
- Agence de la santé et des services sociaux du Saguenay-Lac-Saint-JeanLink provided by the sponsor.
- Université de SherbrookeLink provided by the sponsor.
- Université du Québec à ChicoutimiLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Martin Fortin, MD, M.Sc. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support, management, educational, counselling, follow-up in people with Cardiovascular Disease and Heart Failure, run by Martin Fortin at 1 site in Canada.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2021. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of effects (time frame: T1: Initial evaluation; T2: after three months; T3: one year after T1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319656, which also lists 20 linked publications.
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 29 Sep 2021.