Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT01319656
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2011-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integration of Chronic Disease Rehabilitation Services Into Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of effects', 'timeFrame': 'T1: Initial evaluation; T2: after three months; T3: one year after T1', 'description': 'Short term:\n\n* Self-Efficacy Managing Chronic Disease scale: SEMCD\n* Health Education Impact questionnaire: heiQ\n\nMedium term:\n\n* Risk factors\n* Functional health status/quality of life: SF12\n* Psychological well being: K6\n\nOther:\n\n* Socio-demographic: SD\n* comorbidity\n* co-intervention (CI)\n\nVisites:\n\n* 1:(week:- 2) : Group A and B: DBMA; SD; SF12; K6; SEMCD, heiQ\n* 2a:(week:0) : Group A, (week:12) for Group B: SEMCD, heiQ; CI\n* 2b, 2c: (weeks:4, 8) : Group A: CI\n* 3:(weeks:12) : Group A: SEMCD, heiQ; CI\n* 4:(weeks:52) : Group A: SF12, K6; SEMCD, heiQ; CI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic diseases', 'Primary care', 'Rehabilitation', 'Chronic Care Model', 'Patient centered medical home'], 'conditions': ['Cardiovascular Disease', 'Heart Failure', 'Chronic Obstructive Pulmonary Disease', 'Asthma', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '11816692', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16095434', 'type': 'BACKGROUND', 'citation': 'Tsai 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.'}, {'pmid': '18429737', 'type': 'BACKGROUND', 'citation': 'Dennis 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.'}, {'pmid': '12558376', 'type': 'BACKGROUND', 'citation': 'Rothman 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.'}, {'pmid': '20234224', 'type': 'BACKGROUND', 'citation': 'Chreim 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.'}, {'pmid': '18474705', 'type': 'BACKGROUND', 'citation': 'Hogg 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.'}, {'pmid': '16263889', 'type': 'BACKGROUND', 'citation': 'Clark 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.'}, {'pmid': '18456040', 'type': 'BACKGROUND', 'citation': 'Peytremann-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.'}, {'pmid': '12535399', 'type': 'BACKGROUND', 'citation': 'Gibson 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.'}, {'pmid': '14729296', 'type': 'BACKGROUND', 'citation': 'Ellis 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.'}, {'pmid': '12854339', 'type': 'BACKGROUND', 'citation': 'Gary 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.'}, {'pmid': '17636778', 'type': 'BACKGROUND', 'citation': "Smith 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."}, {'pmid': '20057254', 'type': 'BACKGROUND', 'citation': 'Oelke 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.'}, {'pmid': '20057258', 'type': 'BACKGROUND', 'citation': "Delon 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."}, {'pmid': '17622997', 'type': 'BACKGROUND', 'citation': 'Walsh 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.'}, {'pmid': '17027221', 'type': 'BACKGROUND', 'citation': 'Nolte S, Elsworth GR, Sinclair AJ, Osborne RH. The extent and breadth of benefits from participating in chronic disease self-management courses: a national patient-reported outcomes survey. Patient Educ Couns. 2007 Mar;65(3):351-60. doi: 10.1016/j.pec.2006.08.016. Epub 2006 Oct 5.'}, {'pmid': '31010425', 'type': 'DERIVED', 'citation': 'Contant E, Loignon C, Bouhali T, Almirall J, Fortin M. A multidisciplinary self-management intervention among patients with multimorbidity and the impact of socioeconomic factors on results. BMC Fam Pract. 2019 Apr 22;20(1):53. doi: 10.1186/s12875-019-0943-6.'}, {'pmid': '30626313', 'type': 'DERIVED', 'citation': 'Fortin M, Chouinard MC, Diallo BB, Bouhali T. Integration of chronic disease prevention and management services into primary care (PR1MaC): findings from an embedded qualitative study. BMC Fam Pract. 2019 Jan 9;20(1):7. doi: 10.1186/s12875-018-0898-z.'}, {'pmid': '28018871', 'type': 'DERIVED', 'citation': 'Fortin M, Chouinard MC, Dubois MF, Belanger M, Almirall J, Bouhali T, Sasseville M. Integration of chronic disease prevention and management services into primary care: a pragmatic randomized controlled trial (PR1MaC). CMAJ Open. 2016 Oct 12;4(4):E588-E598. doi: 10.9778/cmajo.20160031. eCollection 2016 Oct-Dec.'}, {'pmid': '23565674', 'type': 'DERIVED', 'citation': 'Fortin M, Chouinard MC, Bouhali T, Dubois MF, Gagnon C, Belanger M. Evaluating the integration of chronic disease prevention and management services into primary health care. BMC Health Serv Res. 2013 Apr 8;13:132. doi: 10.1186/1472-6963-13-132.'}], 'seeAlsoLinks': [{'url': 'http://www.usherbrooke.ca/crmcspl/en/', 'label': 'CIHR Applied Research Chair - Health Services and Policy Research on Chronic Diseases in Primary Care'}, {'url': 'http://www.santesaglac.gouv.qc.ca/', 'label': 'Agence de la santé et des services sociaux du Saguenay-Lac-Saint-Jean'}, {'url': 'http://www.usherbrooke.ca', 'label': 'Université de Sherbrooke'}, {'url': 'http://www.uqac.ca', 'label': 'Université du Québec à Chicoutimi'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* have the potential for rehabilitation\n\nExclusion Criteria:\n\n* serious cognitive problems'}, 'identificationModule': {'nctId': 'NCT01319656', 'acronym': 'PR1MaC', 'briefTitle': 'Integration of Chronic Disease Rehabilitation Services Into Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Adaptation, Implementation and Evaluation of an Intervention Involving the Integration of Chronic Disease Rehabilitation Services Into Primary Care', 'orgStudyIdInfo': {'id': 'FRSQ-24423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Intervention group(n = 163)', 'interventionNames': ['Behavioral: Support, management, educational, counselling, follow-up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Delayed intervention (n = 163)', 'interventionNames': ['Behavioral: Support, management, educational, counselling, follow-up']}, {'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'No intervention group (n = 163)'}], 'interventions': [{'name': 'Support, management, educational, counselling, follow-up', 'type': 'BEHAVIORAL', 'otherNames': ['dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance'], 'description': '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.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G7H 5H6', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CSSS de Chicoutimi, Unité de médecine de famille', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}], 'overallOfficials': [{'name': 'Martin Fortin, MD, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin Fortin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'Ministere de la Sante et des Services Sociaux', 'class': 'OTHER'}, {'name': 'Centre de santé et de services sociaux de Chicoutimi', 'class': 'OTHER'}, {'name': 'Centre de santé et de services sociaux de Jonquière', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Martin Fortin', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}