Motivational Intervention for Asthma

NCT01381159 | Unknown

• 2 other identifiers: MBMC002MOP 111123
• Study Type: interventional
• Target: 58
• 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 behavioural 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 behaviour 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 behaviour change, which is necessary for ensuring daily adherence. Motivational communication (MC) is a client-centred intervention that focuses on enhancing intrinsic motivation to change a particular behaviour, and exploring and resolving ambivalence about behaviour change. Brief MC sessions (e.g., 1-5 x 15-30 minute sessions) have been shown to improve a variety of health behaviours (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 MC to improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MC to improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent asthmatics. It is hypothesized that patients randomized to the MC 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 Communication; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Inhaled corticosteroid adherence

  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

• Asthma Control Test

  12 months post-intervention

• Asthma Self-Efficacy Scale (Tobin)

  12 months post-intervention

• Mini Asthma Quality of Life Questionnaire (Juniper)

  12 months post-intervention

Study Arms (2)

Motivational Communication

EXPERIMENTAL

Up to 3 x 30 minute brief MC sessions within 4-6 week period

Behavioral: Motivational Communication

Control

PLACEBO COMPARATOR

Usual care

Behavioral: Control

Interventions

Motivational Communication BEHAVIORAL

Brief MC sessions focused on medication adherence within 4-6 week period

Motivational Communication

Control BEHAVIORAL

Standard medical care

Control

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 (≥ 1.25 on the Asthma Control Questionnaire)
• Covered by a drug insurance plan (e.g., RAMQ)
• Non-adherent to ICS medication (based on having filled less than 50% 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
• Jewish General Hospital: collaborator

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Links

• Website of the research lab

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Kim L Lavoie, PhD

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

  PRINCIPAL INVESTIGATOR

• Simon L Bacon, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

CA (1)