Motivational Interviewing for Medication Adherence in Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Motivational interviewing
Usual care
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring ADHERENCE, ASTHMA CONTROL, ASTHMA QUALITY OF LIFE, MOTIVATIONAL INTERVIEWING
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hopital du Sacre-Coeur de Montreal
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Usual care
Motivational interviewing
Arm Description
Standard medical care within 4-6 week period
Brief MI sessions within 4-6 week period
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Asthma Control Questionnaire (Juniper)
Asthma Control Test
Asthma Self-Efficacy Scale (Tobin)
Asthma Quality of Life Questionnaire (Juniper)
Full Information
NCT ID
NCT01132430
First Posted
May 27, 2010
Last Updated
February 9, 2018
Sponsor
Hopital du Sacre-Coeur de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT01132430
Brief Title
Motivational Interviewing for Medication Adherence in Asthma
Official Title
Impact of a Motivational Interviewing Intervention on Medication Adherence in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital du Sacre-Coeur de Montreal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
ADHERENCE, ASTHMA CONTROL, ASTHMA QUALITY OF LIFE, MOTIVATIONAL INTERVIEWING
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
Standard medical care within 4-6 week period
Arm Title
Motivational interviewing
Arm Type
Experimental
Arm Description
Brief MI sessions within 4-6 week period
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
Brief MI 3x30 minute sessions within 4-6 week period
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Standard medical care within 4-6 week period
Primary Outcome Measure Information:
Title
Inhaled corticosteroid adherence
Description
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)
Time Frame
12 months post-intervention
Secondary Outcome Measure Information:
Title
Inhaled corticosteroid adherence
Description
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)
Time Frame
6 months post-intervention
Title
Asthma Control Questionnaire (Juniper)
Time Frame
12 months post-intervention, with preliminary data collected at 6 months
Title
Asthma Control Test
Time Frame
12 months post-intervention, with preliminary data collected at 6 months
Title
Asthma Self-Efficacy Scale (Tobin)
Time Frame
12 months post-intervention, with preliminary data collected at 6 months
Title
Asthma Quality of Life Questionnaire (Juniper)
Time Frame
12 months post-intervention, with preliminary data collected at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim L Lavoie, PhD
Organizational Affiliation
Hopital du Sacre-Coeur de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
12. IPD Sharing Statement
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Motivational Interviewing for Medication Adherence in Asthma
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