Motivational Interviewing for Medication Adherence in Asthma

NCT01132430 | Completed Phase 3

• 1 other identifier: MBMC001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

ADHERENCE; ASTHMA CONTROL; ASTHMA QUALITY OF LIFE; MOTIVATIONAL INTERVIEWING

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months post-intervention

Secondary Outcomes (5)

• Inhaled corticosteroid adherence

  6 months post-intervention

• Asthma Control Questionnaire (Juniper)

  12 months post-intervention, with preliminary data collected at 6 months

• Asthma Control Test

  12 months post-intervention, with preliminary data collected at 6 months

• Asthma Self-Efficacy Scale (Tobin)

  12 months post-intervention, with preliminary data collected at 6 months

• Asthma Quality of Life Questionnaire (Juniper)

  12 months post-intervention, with preliminary data collected at 6 months

Study Arms (2)

Usual care

PLACEBO COMPARATOR

Standard medical care within 4-6 week period

Behavioral: Usual care

Motivational interviewing

EXPERIMENTAL

Brief MI sessions within 4-6 week period

Behavioral: Motivational interviewing

Interventions

Motivational interviewing BEHAVIORAL

Brief MI 3x30 minute sessions within 4-6 week period

Motivational interviewing

Usual care BEHAVIORAL

Standard medical care within 4-6 week period

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kim L Lavoie, PhD

  Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-PI, PI is Dr. Kim Lavoie

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: June 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 13, 2018

Record last verified: 2015-07

Locations

CA (1)