AsthmaPhase 3NCT01132430
Motivational Interviewing for Medication Adherence in Asthma
A Phase 3 study testing Motivational interviewing in people with Asthma, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
The high burden of asthma appears to be related to poor asthma control, which is associated with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and worse pulmonary function. Despite the availability of effective treatments, more than 58% of asthmatics are poorly controlled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Mar 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older
- Primary diagnosis of moderate-severe persistent asthma (as per GINA)
- Prescribed inhaled corticosteroid medication (min dose of 250 µg fluticasone equivalent per day) for at least 12 consecutive months
- Uncontrolled asthma (≤ 19 on the Asthma Control Test)
- Covered by a drug insurance plan (e.g., RAMQ)
- Non-adherent to ICS medication (based on having filled less than 30% of their prescriptions over the last year)
- Able to speak English or French.
Who cannot join
- Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
- Severe psychopathology (e.g., schizophrenia)
- Apparent cognitive or language deficit
- Are or plan to become pregnant or move outside of Quebec over the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Motivational Interviewing Intervention on Medication Adherence in Patients With Asthma
The high burden of asthma appears to be related to poor asthma control, which is associated with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and worse pulmonary function. Despite the availability of effective treatments, more than 58% of asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is considered by experts to be one of the most important behavioral factors linked to achieving optimal asthma control. However, there is a paucity of research on interventions specifically designed to improve ICS adherence among adult asthmatics. The vast majority of intervention studies to date used atheoretical interventions to target behavior change, relying mainly upon educational approaches which have been criticised for "failing to translate knowledge into action." This may be due to the fact that most education-based approaches do not specifically address or help patients overcome ambivalence about behavior change, which is necessary for ensuring daily adherence. Motivational interviewing (MI) is a client-centred intervention that focuses on enhancing intrinsic motivation to change a particular behavior, and exploring and resolving ambivalence about behavior change. Brief MI sessions (e.g., 1-5 x 15-30 minute sessions) have been shown to improve a variety of health behaviors (e.g., reduce alcohol consumption, improve dietary habits, increase exercise behaviour, and improve medication adherence) and health outcomes (reduce blood pressure, body mass index, and cholesterol levels). However, no studies to date have assessed the efficacy of using MI to improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MI to improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent asthmatics. It is hypothesized that patients randomized to the MI condition will exhibit significantly improved ICS adherence at 6 and 12-months post-intervention, independent of baseline levels and covariates, relative to patients randomized to the usual care control condition.
- Conditions
- Asthma
- Being tested
- Motivational interviewing, Usual care
- Keywords
- ADHERENCE, ASTHMA CONTROL, ASTHMA QUALITY OF LIFE, MOTIVATIONAL INTERVIEWING
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Brief MI 3x30 minute sessions within 4-6 week period
Usual careBehavioural
Standard medical care within 4-6 week period
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Standard medical care within 4-6 week period Receives: Behavioral: Usual care |
| Motivational interviewing | Experimental | Brief MI sessions within 4-6 week period Receives: Behavioral: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaled corticosteroid adherence
measured according to the following validated equation: # of treatment days (based on the # of canisters filled at the pharmacy x the duration of each prescription) divided by the # of prescription days (# of days the patient is expected to be taking his/her medication)
Measured: 12 months post-intervention
Secondary outcomes (5)
Inhaled corticosteroid adherence
measured according to the following validated equation: # of treatment days (based on the # of canisters filled at the pharmacy x the duration of each prescription) divided by the # of prescription days (# of days the patient is expected to be taking his/her medication)
Measured: 6 months post-intervention
Asthma Control Questionnaire (Juniper)
Measured: 12 months post-intervention, with preliminary data collected at 6 months
Asthma Control Test
Measured: 12 months post-intervention, with preliminary data collected at 6 months
Asthma Self-Efficacy Scale (Tobin)
Measured: 12 months post-intervention, with preliminary data collected at 6 months
Asthma Quality of Life Questionnaire (Juniper)
Measured: 12 months post-intervention, with preliminary data collected at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJun 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Bacon, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Kim L Lavoie, PhD, Principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132430
- Sponsor's protocol ID
- MBMC001
- Status last verified
- Jul 2015
- First submitted
- 27 May 2010
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Motivational Interviewing Intervention on Medication Adherence in Patients With Asthma
- ClinicalTrials.gov ID
- NCT01132430
- Acronym / sponsor ID
- MBMC001
- Conditions
- Asthma
- Keywords
- ADHERENCE, ASTHMA CONTROL, ASTHMA QUALITY OF LIFE, MOTIVATIONAL INTERVIEWING
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 May 2010 (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 high burden of asthma appears to be related to poor asthma control, which is associated with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and worse pulmonary function. Despite the availability of effective treatments, more than 58% of asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is considered by experts to be one of the most important behavioral factors linked to achieving optimal asthma control. However, there is a paucity of research on interventions specifically designed to improve ICS adherence among adult asthmatics. The vast majority of intervention studies to date used atheoretical interventions to target behavior change, relying mainly upon educational approaches which have been criticised for "failing to translate knowledge into action." This may be due to the fact that most education-based approaches do not specifically address or help patients overcome ambivalence about behavior change, which is necessary for ensuring daily adherence. Motivational interviewing (MI) is a client-centred intervention that focuses on enhancing intrinsic motivation to change a particular behavior, and exploring and resolving ambivalence about behavior change. Brief MI sessions (e.g., 1-5 x 15-30 minute sessions) have been shown to improve a variety of health behaviors (e.g., reduce alcohol consumption, improve dietary habits, increase exercise behaviour, and improve medication adherence) and health outcomes (reduce blood pressure, body mass index, and cholesterol levels). However, no studies to date have assessed the efficacy of using MI to improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MI to improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent asthmatics. It is hypothesized that patients randomized to the MI condition will exhibit significantly improved ICS adherence at 6 and 12-months post-intervention, independent of baseline levels and covariates, relative to patients randomized to the usual care control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Behavioral: Usual careStandard medical care within 4-6 week period |
| Motivational interviewing | Experimental | Behavioral: Motivational interviewingBrief MI sessions within 4-6 week period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 years and older
- Primary diagnosis of moderate-severe persistent asthma (as per GINA)
- Prescribed inhaled corticosteroid medication (min dose of 250 µg fluticasone equivalent per day) for at least 12 consecutive months
- Uncontrolled asthma (≤ 19 on the Asthma Control Test)
- Covered by a drug insurance plan (e.g., RAMQ)
Key exclusion criteria (4 listed)
- Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
- Severe psychopathology (e.g., schizophrenia)
- Apparent cognitive or language deficit
- Are or plan to become pregnant or move outside of Quebec over the course of the study.
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 |
|---|---|---|
| Motivational interviewingBrief MI 3x30 minute sessions within 4-6 week period | Behavioural | Motivational interviewing |
| Usual careStandard medical care within 4-6 week period | Behavioural | Usual care |
Primary outcome
Inhaled corticosteroid adherence
Time frame: 12 months post-intervention
measured according to the following validated equation: # of treatment days (based on the # of canisters filled at the pharmacy x the duration of each prescription) divided by the # of prescription days (# of days the patient is expected to be taking his/her medication)
5 secondary outcomes
Inhaled corticosteroid adherence
Time frame: 6 months post-intervention
Asthma Control Questionnaire (Juniper)
Time frame: 12 months post-intervention, with preliminary data collected at 6 months
Asthma Control Test
Time frame: 12 months post-intervention, with preliminary data collected at 6 months
Asthma Self-Efficacy Scale (Tobin)
Time frame: 12 months post-intervention, with preliminary data collected at 6 months
Asthma Quality of Life Questionnaire (Juniper)
Time frame: 12 months post-intervention, with preliminary data collected at 6 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 13 Feb 2018.
Related trials for Asthma
RecruitingPhase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Severe Asthma
Active, not recruiting
Nasal Immune Challenge Study
Innate Inflammatory Response, Asthma
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Innate Immunity, Mucosal Immunity
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.
Kim L Lavoie, PhD principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational interviewing in people with Asthma, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal 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 7 inclusion and 4 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 13 Feb 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Inhaled corticosteroid adherence (time frame: 12 months post-intervention). 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 13 Feb 2018.