AsthmaRESPIRENCT02093013
Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence
A study testing Integrated care program in people with Asthma, run by Laval University at 1 site in Canada.
Trial summary
The investigators propose to implement and evaluate an integrated care program for enhancing the care of patients with asthma in a region of Quebec province, Canada. The investigators will implement our intervention in a family medicine group practice setting and plan to deliver it to 150 experimental group subjects. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- Integrated care program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteCanada
- Study dates
- May 2004to Jul 2007
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals aged 12 to 45 years, for whom the pharmacists had dispensed at least one anti-asthma drug in the previous six months were screened and randomly contacted by phone. Those who reported an asthma diagnosis and who were using a short-acting beta-2-agonist (SABA) >3 times a week (except before exercise) or a corticosteroid (inhaled or oral), irrespective of frequency were included.
Who cannot join
- Pregnancy, no prior asthma diagnosis, participation in an ongoing respiratory study, or another respiratory illness.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier affilié universitaire de Québec
Québec, Quebec, G1S 4L8
About this study
Official title: Impact of an Integrated Care Intervention Program on Asthmatic Patients.
The investigators propose to implement and evaluate an integrated care program for enhancing the care of patients with asthma in a region of Quebec province, Canada. The investigators will implement our intervention in a family medicine group practice setting and plan to deliver it to 150 experimental group subjects. The investigators will simultaneously study 300 control subjects who are receiving usual care in other regions of the province of Quebec. Our hypothesis is that the program will improve the quality of life of patients with asthma exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of asthma, and a number of variables that relate to the conceptual model selected as a framework for this study (the PRECEDE-PROCEED model of Green and Kreuter).
- Conditions
- Asthma
- Being tested
- Integrated care program
- Keywords
- asthma, intervention, medication adherence, inhaled corticosteroids, asthma control, integrated care
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated care programOther
Integrated care program meant in effect, calling on the family medicine group (FMG) nurses to evaluate and support asthmatic patients. The FMG and asthma education centre (AEC) nurses received special training and followed a protocol based on the theoretical model and the Canadian asthma management recommendations then in force. The protocol had five main aspects: 1) asthma assessment, 2) self-management, 3) environment and lifestyle, 4) collaborative care plan, and 5) information sharing and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Integrated care program | Experimental | Not described Receives: Other: Integrated care program |
| Control group | No intervention | This group kept receiving usual care from their health care professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
The primary outcome was asthma control, measured with the validated Asthma Control Questionnaire.
Measured: One year
Secondary outcomes (1)
Adherence to ICS
Adherence to medication for each participant reporting an inhaled corticosteroids (ICS) prescription was assessed using two measures; the validated Morisky medication adherence scale (MMAS-4) composed of 4 questions (yes/no) about past medication use patterns, and the medication possession ratio (MPR), a validated objective measure based on pharmacy records.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMay 2004
- Primary completionJan 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Line Guénette, Laval University
- Investigators
- Jocelyne Moisan, Ph.D., Principal investigator, URESP, Centre hospitalier affilié universitaire de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093013
- Sponsor's protocol ID
- DR-002-1077
- Acronym
- RESPIRE
- Status last verified
- Mar 2017
- First submitted
- 18 Mar 2014
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jobin MS, Moisan J, Bolduc Y, Dorval E, Boulet LP, Gregoire JP. Factors associated with the appropriate use of asthma drugs. Can Respir J. 2011 Mar-Apr;18(2):97-104. doi: 10.1155/2011/426528.
PubMed 21499595Guenette L, Breton MC, Gregoire JP, Jobin MS, Bolduc Y, Boulet LP, Dorval E, Moisan J. Effectiveness of an asthma integrated care program on asthma control and adherence to inhaled corticosteroids. J Asthma. 2015;52(6):638-45. doi: 10.3109/02770903.2014.999084.
PubMed 25539138Adouni Lawani M, Zongo F, Breton MC, Moisan J, Gregoire JP, Dorval E, Boulet LP, Jobin MS, Guenette L. Factors associated with adherence to asthma treatment with inhaled corticosteroids: A cross-sectional exploratory study. J Asthma. 2018 Mar;55(3):318-329. doi: 10.1080/02770903.2017.1326131. Epub 2017 May 26.
PubMed 28471286
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Integrated Care Intervention Program on Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT02093013
- Acronym / sponsor ID
- RESPIRE / DR-002-1077
- Conditions
- Asthma
- Keywords
- asthma, intervention, medication adherence, inhaled corticosteroids, asthma control, integrated care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- May 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Mar 2014 (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.
The investigators propose to implement and evaluate an integrated care program for enhancing the care of patients with asthma in a region of Quebec province, Canada. The investigators will implement our intervention in a family medicine group practice setting and plan to deliver it to 150 experimental group subjects. The investigators will simultaneously study 300 control subjects who are receiving usual care in other regions of the province of Quebec. Our hypothesis is that the program will improve the quality of life of patients with asthma exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of asthma, and a number of variables that relate to the conceptual model selected as a framework for this study (the PRECEDE-PROCEED model of Green and Kreuter).
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 |
|---|---|---|
| Integrated care program | Experimental | Other: Integrated care program |
| Control group | No intervention | –This group kept receiving usual care from their health care professionals. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Individuals aged 12 to 45 years, for whom the pharmacists had dispensed at least one anti-asthma drug in the previous six months were screened and randomly contacted by phone. Those who reported an asthma diagnosis and who were using a short-acting beta-2-agonist (SABA) >3 times a week (except before exercise) or a corticosteroid (inhaled or oral), irrespective of frequency were included.
Key exclusion criteria (1 listed)
- Pregnancy, no prior asthma diagnosis, participation in an ongoing respiratory study, or another respiratory illness.
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 |
|---|---|---|
| Integrated care programIntegrated care program meant in effect, calling on the family medicine group (FMG) nurses to evaluate and support asthmatic patients. The FMG and asthma education centre (AEC) nurses received special training and followed a protocol based on the theoretical model and the Canadian asthma management recommendations then in force. The protocol had five main aspects: 1) asthma assessment, 2) self-management, 3) environment and lifestyle, 4) collaborative care plan, and 5) information sharing and follow-up. | Other | Integrated care program |
Primary outcome
Asthma control
Time frame: One year
The primary outcome was asthma control, measured with the validated Asthma Control Questionnaire.
1 secondary outcome
Adherence to ICS
Time frame: One year
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 30 Mar 2017.
- Results publication: PubMed 21499595Jobin MS, Moisan J, Bolduc Y, Dorval E, Boulet LP, Gregoire JP. Factors associated with the appropriate use of asthma drugs. Can Respir J. 2011 Mar-Apr;18(2):97-104. doi: 10.1155/2011/426528.
- Results publication: PubMed 25539138Guenette L, Breton MC, Gregoire JP, Jobin MS, Bolduc Y, Boulet LP, Dorval E, Moisan J. Effectiveness of an asthma integrated care program on asthma control and adherence to inhaled corticosteroids. J Asthma. 2015;52(6):638-45. doi: 10.3109/02770903.2014.999084.
- Derived from this study: PubMed 28471286Adouni Lawani M, Zongo F, Breton MC, Moisan J, Gregoire JP, Dorval E, Boulet LP, Jobin MS, Guenette L. Factors associated with adherence to asthma treatment with inhaled corticosteroids: A cross-sectional exploratory study. J Asthma. 2018 Mar;55(3):318-329. doi: 10.1080/02770903.2017.1326131. Epub 2017 May 26.
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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.
Jocelyne Moisan, Ph.D. principal investigator
URESP, Centre hospitalier affilié universitaire de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care program in people with Asthma, run by Laval University at 1 site in Canada.
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 1 inclusion and 1 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 30 Mar 2017. 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 Canada. 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?
Asthma control (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02093013, which also lists 3 linked publications.
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 30 Mar 2017.