Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
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
Verified date | May 2016 |
Source | Centre Hospitalier du Centre du Valais |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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:
1. Processes of care
2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC
instrument)
3. Measure of self-efficacy (intermediary outcome)
4. 6-minutes walking test, nb of COPD exacerbations, % of current smokers
5. Healthcare utilization: unscheduled ambulatory care visits
6. Care satisfaction
7. 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.
Status | Completed |
Enrollment | 57 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Valaisan de Pneumologie, Centre Hospitalier du Centre du Valais | Crans Montana | Valais |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier du Centre du Valais | Association des médecins de famille du Valais, Fondation Bangarter, Ligue pulmonaire valaisanne, Promotion santé Valais, Swiss National Science Foundation, Swiss School of Public Health (personal grant to Isabelle Peytremann-Bridevaux), University of Lausanne Hospitals |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Self-efficacy | 12 months | No | |
Other | Healthcare utilization | 12 months | No | |
Other | Care satisfaction | 12 months | No | |
Other | Process of implementation of the intervention | 12 months | No | |
Primary | Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT)) | 12 months | No | |
Primary | All-cause hospitalizations (past 12 months) | 12 months | No | |
Secondary | Processes of care, patient assessment of chronic illness care (PACIC) | 12 months | No | |
Secondary | 6-minutes walking test | 12 months | No | |
Secondary | COPD exacerbations | 12 months | No | |
Secondary | % smokers | 12 months | No |
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