NCT02001922

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:

  1. 1.Processes of care
  2. 2.Patients' assessment of how care is congruent with the Chronic Care Model (PACIC instrument)
  3. 3.Measure of self-efficacy (intermediary outcome)
  4. 4.6-minutes walking test, nb of COPD exacerbations, % of current smokers
  5. 5.Healthcare utilization: unscheduled ambulatory care visits
  6. 6.Care satisfaction
  7. 7.Measures of the process of implementation of the intervention

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

November 8, 2013

Last Update Submit

May 18, 2016

Conditions

Keywords

COPDPulmonary disease, chronic obstructiveIntegrated careOutcome and process assessmentQuality indicators, Health careSelf-management,Patient empowermentQuantitative and qualitative methods

Outcome Measures

Primary Outcomes (2)

  • Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT))

    12 months

  • All-cause hospitalizations (past 12 months)

    12 months

Secondary Outcomes (4)

  • Processes of care, patient assessment of chronic illness care (PACIC)

    12 months

  • 6-minutes walking test

    12 months

  • COPD exacerbations

    12 months

  • % smokers

    12 months

Other Outcomes (4)

  • Self-efficacy

    12 months

  • Healthcare utilization

    12 months

  • Care satisfaction

    12 months

  • +1 more other outcomes

Study Arms (2)

COPD integrated care

EXPERIMENTAL

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.

Other: COPD integrated care

Usual care

NO INTERVENTION

Usual COPD care

Interventions

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.

COPD integrated care

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Valaisan de Pneumologie, Centre Hospitalier du Centre du Valais

Crans-Montana, Valais, 3963, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePatient Participation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Isabelle Peytremann-Bridevaux, MD, MPH, DSc

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR
  • Bernard Burnand, MD, MPH

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR
  • Jean-Marie Tschopp, MD

    Centre Hospitalier du Centre du Valais

    PRINCIPAL INVESTIGATOR
  • Pierre-Olivier Bridevaux, MD, MSc

    Centre Hospitalier du Centre du Valais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2013

First Posted

December 5, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations