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A Nurse Led Programme to Improve Adherence in Difficult Asthma

NCT01064869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-03-15

No results posted yet for this study

Summary

Approximately 5% of adults with asthma have difficult to control disease but these account for up to 80% of total cost of asthma due to recurrent healthcare contact including hospital admission. The reasons for "difficult asthma" are multi-factorial, but an important element in many patients is non-adherence to steroid therapy. Recent qualitative analysis by the investigators group has identified a number of both individual and group themes, related to non-adherence with steroid treatment. Many of these themes such as steroid phobia, inaccurate / lack of knowledge, negative attitudes and inability to deal with side-effects, are potentially modifiable and the investigators believe, unless these issues are addressed, at an individual patient level, adherence is unlikely to improve. This randomised parallel group study will examine a nursing intervention to try and improve adherence and as a consequence, asthma control, in a group of difficult asthmatics where non-adherence has been identified as a significant factor. The study will use a needs-led menu driven individualised intervention and will compare this to current best asthma care. The primary outcome measure will be adherence to therapy, however asthma control, lung function and asthma related quality of life, patients' attitudes to asthma and treatment and their levels of anxiety and depression will also be examined. Addressing the issue of non-adherence is fundamental to improving asthma management in this difficult group with concomitant reduction on health care costs and improvements in patients' quality of life

Conditions

Interventions

BEHAVIORAL

Pyscho-behavioural

A nurse-led programme of intervention will be devised. Patients will attend weekly for a period of 12 weeks. It will have two stages incorporating: 1\. Structured interview to identify demographic information and individual reasons for non-adherence and assessment of readiness to change behaviour This will be followed by an individualised package incorporating: 1. A structured asthma education programme, to address any gaps in asthma knowledge or requests for information 2. Motivational interviewing based on stages of change model to encourage change and adherence 3. Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients

Sponsors & Collaborators

  • Belfast Health and Social Care Trust

    lead OTHER

Principal Investigators

  • Liam Heaney, MD · Belfast Health and Social Care Trust

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064869 on ClinicalTrials.gov