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Soins intégrés BPCO (Broncho-pneumopathie Chronique Obstructive) en Valais - Mieux Vivre Avec ma BPCO (COPD Integrated Care Program Valais - Living Well With COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
COPD integrated care
Sponsored by
Centre Hospitalier du Centre du Valais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Pulmonary disease, chronic obstructive, Integrated care, Outcome and process assessment, Quality indicators, Health care, Self-management,, Patient empowerment, Quantitative and qualitative methods

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of COPD (GOLD stage 1-symptomatic to 4)
  • Age >= 35 years
  • Residing in the canton of Valais Switzerland, non-institutionalized
  • Informed consent

Exclusion Criteria:

  • Hospitalization during previous 4 weeks
  • Pulmonary rehabilitation during past 18 months
  • Estimated life expectancy < 12 months
  • Obvious cognitive impairment
  • Not speaking or understanding French well enough

Sites / Locations

  • Centre Valaisan de Pneumologie, Centre Hospitalier du Centre du Valais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

COPD integrated care

Usual care

Arm Description

The intervention will target COPD integrated care, and include a combination of patient-related, professional and organizational elements. It will be centered on patients' needs and focus on self-management education, proactive follow-up (scheduled visits and/or phone contacts), team work, healthcare professionals' training, promotion of pulmonary rehabilitation, physical activity and smoking cessation.

Usual COPD care

Outcomes

Primary Outcome Measures

Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT))
All-cause hospitalizations (past 12 months)

Secondary Outcome Measures

Processes of care, patient assessment of chronic illness care (PACIC)
6-minutes walking test
COPD exacerbations
% smokers

Full Information

First Posted
November 8, 2013
Last Updated
May 18, 2016
Sponsor
Centre Hospitalier du Centre du Valais
Collaborators
University of Lausanne Hospitals, Promotion santé Valais, Ligue pulmonaire valaisanne, Association des médecins de famille du Valais, Fondation Bangarter, Swiss National Science Foundation, Swiss School of Public Health (personal grant to Isabelle Peytremann-Bridevaux)
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1. Study Identification

Unique Protocol Identification Number
NCT02001922
Brief Title
Soins intégrés BPCO (Broncho-pneumopathie Chronique Obstructive) en Valais - Mieux Vivre Avec ma BPCO (COPD Integrated Care Program Valais - Living Well With COPD)
Official Title
COPD Integrated Care Program Valais - Living Well With COPD, a Pilot Study Assessing Feasibility, Acceptability and Effectiveness in the Canton of Valais, Switzerland
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier du Centre du Valais
Collaborators
University of Lausanne Hospitals, Promotion santé Valais, Ligue pulmonaire valaisanne, Association des médecins de famille du Valais, Fondation Bangarter, Swiss National Science Foundation, Swiss School of Public Health (personal grant to Isabelle Peytremann-Bridevaux)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by acute exacerbations that contribute to physical impairment and increased healthcare use and costs. Given the increasing burden of this disease in terms of morbidity, disability, mortality and costs, innovative care models centered on patients and aiming at improving quality and comprehensiveness of care are needed. Effective implementation and evaluation of chronic disease management - integrated care(CDM-IC) programs, in the real world context is of great importance. Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of Valais. Design: The evaluation plan of this study will combine both quantitative (controlled before-after study design) and qualitative methods (focus groups with COPD patients and practicing healthcare professionals). Setting: French-speaking part of the canton of Valais. Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease, non-institutionalized and residing in the canton of Valais. The control group of patients will be constituted of age and gender-matched COPD patients from the Swiss COPD cohort study. Measures: Quantitative part: Primary outcomes: Generic and disease-specific health-related quality-of-life and all-cause hospitalizations (past 12 months) Other outcomes: Processes of care Patients' assessment of how care is congruent with the Chronic Care Model (PACIC instrument) Measure of self-efficacy (intermediary outcome) 6-minutes walking test, nb of COPD exacerbations, % of current smokers Healthcare utilization: unscheduled ambulatory care visits Care satisfaction Measures of the process of implementation of the intervention Qualitative part: At 12 months: conduct of two focus groups of participating COPD patients, and of two focus groups of participating healthcare professionals.
Detailed Description
Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by acute exacerbations that contribute to physical impairment and increased healthcare use and costs. Given the increasing burden of this disease in terms of morbidity, disability, mortality and costs, innovative care models centered on patients and aiming at improving quality and comprehensiveness of care are needed. Effective implementation and evaluation of chronic disease management - integrated care(CDM-IC) programs, in the real world context is of great importance. Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of Valais. Design: The evaluation plan of this study will combine both quantitative and qualitative methods. A controlled before-after study design will be considered for the quantitative part of the project, and the qualitative part will include the conduct of focus groups with COPD patients and practicing healthcare professionals. Setting: French-speaking part of the canton of Valais. Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease, aged > 35 years, non-institutionalized and residing in the canton of Valais. Patients will be recruited by primary care and pulmonary care physicians practicing in the French-speaking part of the canton of Valais. The control group of patients will be constituted of age and gender-matched COPD patients already included in the Swiss COPD cohort study. Measures: Quantitative part: Primary outcomes: Generic and disease-specific health-related quality-of-life(Chronic Respiratory Questionnaire (CRQ), SF-36 and COPD Assessment Test (CAT)) and all-cause hospitalizations (past 12 months) Other outcomes: Processes of care (% patients having participated to self-management education sessions, % patients having received/used the action plan, % patients having received smoking cessation recommendations, % patients having received advices/participated to participate to pulmonary rehabilitation, % patients having received influenza immunization during the past 12 months, % patients receiving appropriate treatment, nb of consultations with primary care physician/pulmonary care physician/other, nb of contacts with the hotline) Patients' assessment of how care is congruent with the Chronic Care Model (PACIC instrument) Measure of self-efficacy (intermediary outcome) Health behaviors, symptoms and physical activity measures: 6-minutes walking test, nb of COPD exacerbations during past (past 12 months), % of current smokers Healthcare utilization: unscheduled ambulatory care visits Care satisfaction Measures of the process of implementation of the intervention (nb of recruiting practices and physicians, nb of participating practices and physicians, nb of and patients, of drop-outs, satisfaction of healthcare professionals towards COPD program) Qualitative part: conduct of two focus groups of participating COPD patients, and of two focus groups of participating healthcare professionals, 12 months after the start of the recruitment. Development and implementation of the intervention: The development of the current COPD program in Valais is being implemented in collaboration with physicians working in private practices (family physicians and specialists), physiotherapists, pharmacists and nurse specialists. It will involve academic and public institutions, as well as practitioners. The program has been launched in March 2013, after a preliminary phase involving the conduct of focus groups. Their aims were to explore the needs and barriers to better care, as well as the shape of the targeted CDM elements for better implementation in real life, from the point of view of COPD patients and healthcare professionals. The CDM intervention considered in the "Soins intégrés BPCO en Valais - Mieux vivre avec ma BPCO" program is based on the " Living well with COPD programme " developed by Prof. Bourbeau & al at McGill University, Montreal, Canada. The "Soins intégrés BPCO en Valais - Mieux vivre avec ma BPCO" program will include a combination of patient-related, professional and organizational elements. It will be centered on patients' needs and focus on self-management education, proactive follow-up (scheduled visits and/or phone contacts), team work, healthcare professionals' training, and promotion of pulmonary rehabilitation, physical activity as well as smoking cessation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Pulmonary disease, chronic obstructive, Integrated care, Outcome and process assessment, Quality indicators, Health care, Self-management,, Patient empowerment, Quantitative and qualitative methods

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD integrated care
Arm Type
Experimental
Arm Description
The intervention will target COPD integrated care, and include a combination of patient-related, professional and organizational elements. It will be centered on patients' needs and focus on self-management education, proactive follow-up (scheduled visits and/or phone contacts), team work, healthcare professionals' training, promotion of pulmonary rehabilitation, physical activity and smoking cessation.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual COPD care
Intervention Type
Other
Intervention Name(s)
COPD integrated care
Intervention Description
The intervention will target COPD integrated care, and include a combination of patient-related, professional and organizational elements. It will be centered on patients' needs and focus on self-management education, proactive follow-up (scheduled visits and/or phone contacts), team work, healthcare professionals' training, promotion of pulmonary rehabilitation, physical activity and smoking cessation.
Primary Outcome Measure Information:
Title
Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT))
Time Frame
12 months
Title
All-cause hospitalizations (past 12 months)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Processes of care, patient assessment of chronic illness care (PACIC)
Time Frame
12 months
Title
6-minutes walking test
Time Frame
12 months
Title
COPD exacerbations
Time Frame
12 months
Title
% smokers
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Self-efficacy
Time Frame
12 months
Title
Healthcare utilization
Time Frame
12 months
Title
Care satisfaction
Time Frame
12 months
Title
Process of implementation of the intervention
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD (GOLD stage 1-symptomatic to 4) Age >= 35 years Residing in the canton of Valais Switzerland, non-institutionalized Informed consent Exclusion Criteria: Hospitalization during previous 4 weeks Pulmonary rehabilitation during past 18 months Estimated life expectancy < 12 months Obvious cognitive impairment Not speaking or understanding French well enough
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Peytremann-Bridevaux, MD, MPH, DSc
Organizational Affiliation
Lausanne University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard Burnand, MD, MPH
Organizational Affiliation
Lausanne University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Marie Tschopp, MD
Organizational Affiliation
Centre Hospitalier du Centre du Valais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Olivier Bridevaux, MD, MSc
Organizational Affiliation
Centre Hospitalier du Centre du Valais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Valaisan de Pneumologie, Centre Hospitalier du Centre du Valais
City
Crans Montana
State/Province
Valais
ZIP/Postal Code
3963
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Soins intégrés BPCO (Broncho-pneumopathie Chronique Obstructive) en Valais - Mieux Vivre Avec ma BPCO (COPD Integrated Care Program Valais - Living Well With COPD)

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