Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01381159 |
| Other study ID # |
MBMC002 |
| Secondary ID |
MOP 111123 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2011 |
| Est. completion date |
August 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Hopital du Sacre-Coeur de Montreal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
Description:
Background: The high burden of asthma, which affects 300 million people worldwide, 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. The
availability of effective treatments suggests that asthma can be well controlled in most
patients. However, Canadian statistics reveal that over 58% of asthmatics are poorly
controlled. Achieving optimal asthma control relies upon several behavioral factors,
including minimizing exposure to known triggers (e.g., pets, dust, pollen) and improving
health behaviors (e.g,. quitting smoking and adhering to medication). Of these, 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. This is because
taking ICS medications as prescribed (i.e., good adherence) has been shown to be effective
for achieving good asthma control even in patients who fail to adequately manage/minimize
exposure to known triggers (e.g., indoor allergens, exercise). Despite the efficacy of ICS's,
recent trends in adherence behaviour suggest that asthmatics are not adherent to these
medications, with rates being as low as 32%, even in patients with severe asthma.
Explanations range from simply forgetting to having distorted/ erroneous illness and
medication beliefs. Currently, there is a paucity of research on interventions specifically
designed to improve ICS adherence among adult asthmatics. Most previous work has been
conducted in pediatric samples which have yielded inconsistent results that are difficult to
generalize to adult samples. Of the studies conducted among adults, most suffer from
important methodological limitations (e.g., small sample sizes, no intent to treat analyses,
failure to control for contact time, no objective measure of adherence) that make it
difficult to either generalize findings or interpret them with confidence. Most importantly,
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 (i.e., take medication as prescribed), 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). No studies to date have assessed the efficacy of using MC to improve ICS
adherence in asthmatics. Objective: The purpose of this study is to conduct a single site RCT
to assess the efficacy of using MC to improve daily medication (ICS) adherence in a sample of
poorly controlled, non-adherent asthmatics. A brief (3-5 x 15-30 minute sessions), manualized
MC intervention was developed by our laboratory using pilot funding. This intervention is
empirically-driven and uses established behavioural and motivational strategies to encourage
change. Methods: 182 poorly controlled, non-adherent adult asthmatics will be recruited from
the outpatient asthma clinic of Hôpital du Sacré-Coeur de Montreal (HSCM). Patients will be
screened on the day of their asthma clinic visit to verify eligibility. Eligible patients
consenting to have their medical and pharmacy records verified by the research team and who
are identified as both having poorly controlled asthma (Asthma Control Questionnaire score
≥1.25) and being non-adherent to ICS medication (filled < 50% of their ICS medication in the
last year) will be invited to participate in the study. Patients will undergo baseline
assessments (pulmonary function, asthma control, self-efficacy, and quality of life) and will
then be randomly assigned to a usual care + MC or usual care comparison group. This trial has
been designed to conform to the CONSORT guidelines. The primary outcome measure will be ICS
adherence at 12 months post-intervention, with preliminary analyses conducted at 6-months
post-intervention. Adherence will be 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). Data will be obtained by accessing the patient's pharmacy
records and drug insurance databases (i.e., RAMQ, reMed). Secondary outcomes include
self-reported medication adherence, adherence motivation, stage of change, pulmonary
function, asthma control, self-efficacy, and quality of life scores 6 & 12 months
post-intervention. Impact: This will be the first appropriately designed RCT to test the
impact of a brief, manualized MC intervention on asthma medication (ICS) adherence that may
be easily incorporated into existing education programs and/or clinical practice and may
significantly improve asthma outcomes.
