Chronic Obstructive Pulmonary Disease (COPD)NCT02001922
Soins intégrés BPCO (Broncho-pneumopathie Chronique Obstructive) en Valais - Mieux Vivre Avec ma BPCO (COPD Integrated Care Program Valais - Living Well With COPD)
A study testing COPD integrated care in people with Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier du Centre du Valais at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- COPD integrated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD (GOLD stage 1-symptomatic to 4)
- Age >= 35 years
- Residing in the canton of Valais Switzerland, non-institutionalized
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Valaisan de Pneumologie, Centre Hospitalier du Centre du Valais
Crans-Montana, Valais, 3963
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- COPD integrated care
- Keywords
- COPD, Pulmonary disease, chronic obstructive, Integrated care, Outcome and process assessment, Quality indicators, Health care, Self-management,, Patient empowerment, Quantitative and qualitative methods
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD integrated careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: COPD integrated care |
| Usual care | No intervention | Usual COPD care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT))
Measured: 12 months
All-cause hospitalizations (past 12 months)
Measured: 12 months
Secondary outcomes (4)
Processes of care, patient assessment of chronic illness care (PACIC)
Measured: 12 months
6-minutes walking test
Measured: 12 months
COPD exacerbations
Measured: 12 months
% smokers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Centre du Valais
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Pierre-Olivier Bridevaux, Centre Hospitalier du Centre du Valais
- Investigators
- Isabelle Peytremann-Bridevaux, MD, MPH, DSc, Principal investigator, University of Lausanne HospitalsBernard Burnand, MD, MPH, Principal investigator, University of Lausanne HospitalsJean-Marie Tschopp, MD, Principal investigator, Centre Hospitalier du Centre du ValaisPierre-Olivier Bridevaux, MD, MSc, Principal investigator, Centre Hospitalier du Centre du Valais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001922
- Sponsor's protocol ID
- COPD Integrated Care Valais
- Status last verified
- May 2016
- First submitted
- 8 Nov 2013
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02001922
- Acronym / sponsor ID
- COPD Integrated Care Valais
- Keywords
- COPD, Pulmonary disease, chronic obstructive, Integrated care, Outcome and process assessment, Quality indicators, Health care, Self-management,, Patient empowerment, Quantitative and qualitative methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Hospitalier du Centre du ValaisUniversity, hospital or other
- 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)
- Study start
- Mar 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD integrated care | Experimental | Other: COPD integrated careThe 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 care | No intervention | –Usual COPD care |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD (GOLD stage 1-symptomatic to 4)
- Age >= 35 years
- Residing in the canton of Valais Switzerland, non-institutionalized
- Informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD integrated careThe 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 |
Primary outcome
Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT))
Time frame: 12 months
All-cause hospitalizations (past 12 months)
Time frame: 12 months
4 secondary outcomes
Processes of care, patient assessment of chronic illness care (PACIC)
Time frame: 12 months
6-minutes walking test
Time frame: 12 months
COPD exacerbations
Time frame: 12 months
% smokers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Peytremann-Bridevaux, MD, MPH, DSc principal investigator
University of Lausanne Hospitals
Bernard Burnand, MD, MPH principal investigator
University of Lausanne Hospitals
Jean-Marie Tschopp, MD principal investigator
Centre Hospitalier du Centre du Valais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD integrated care in people with Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier du Centre du Valais at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT)) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.