NCT01319656

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

March 21, 2011

Last Update Submit

September 27, 2021

Conditions

Keywords

Chronic diseasesPrimary careRehabilitationChronic Care ModelPatient centered medical home

Outcome Measures

Primary Outcomes (1)

  • 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

    T1: Initial evaluation; T2: after three months; T3: one year after T1

Study Arms (3)

Group A

ACTIVE COMPARATOR

Intervention group(n = 163)

Behavioral: Support, management, educational, counselling, follow-up

Group B

ACTIVE COMPARATOR

Delayed intervention (n = 163)

Behavioral: Support, management, educational, counselling, follow-up

Group C

NO INTERVENTION

No intervention group (n = 163)

Interventions

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.

Also known as: dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance
Group AGroup B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • serious cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSSS de Chicoutimi, Unité de médecine de famille

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Related Publications (20)

  • 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: 11816692BACKGROUND
  • 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: 16095434BACKGROUND
  • 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: 18429737BACKGROUND
  • 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: 12558376BACKGROUND
  • 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: 20234224BACKGROUND
  • 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: 18474705BACKGROUND
  • 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: 16263889BACKGROUND
  • 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: 18456040BACKGROUND
  • 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: 12535399BACKGROUND
  • 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: 14729296BACKGROUND
  • 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: 12854339BACKGROUND
  • 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: 17636778BACKGROUND
  • 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: 20057254BACKGROUND
  • 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: 20057258BACKGROUND
  • 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: 17622997BACKGROUND
  • 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: 17027221BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHeart FailurePulmonary Disease, Chronic ObstructiveAsthmaDiabetes MellitusChronic Disease

Interventions

Palliative CareTherapeuticsCounselingRespiratory TherapyExercisePsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient CareHealth ServicesHealth Care Facilities Workforce and ServicesMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRehabilitation

Study Officials

  • Martin Fortin, MD, M.Sc.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2012

Study Completion

November 1, 2013

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations