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A Nurse Led Programme to Improve Adherence in Difficult Asthma

This study has been completed.
Sponsor:
Collaborator:
Northern Ireland Research and Development Office
Information provided by:
Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01064869
First received: February 8, 2010
Last updated: June 29, 2010
Last verified: February 2005
History of Changes
  Purpose

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


Condition Intervention
Asthma
 Behavioral: Pyscho-behavioural

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Benefits of an Individualised Menu Driven Nurse Led Programme to Improve Adherence in Difficult Asthma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Belfast Health and Social Care Trust:

Primary Outcome Measures:
  • Adherence to Inhaled combination therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma control score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Asthma Quality of Life Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hospital anxiety and depression scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lung function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduction in rescue courses of Steroids [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psycho-educational intervention

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
 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
No Intervention: usual care
Standard asthma management
 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Filling <50% of prescription refills for inhaled combination therapy

  • Persisting asthma symptoms (ACS >3) despite detailed assessment and management
  • Minimal maintenance therapy of long acting beta2-agonist and inhaled steroids (800mg BDP or equivalent)
  • At least 1 course of systemic steroids in the preceding 12 months.

Exclusion Criteria:

Medication adherence

  • A condition other than asthma contributing to persisting symptoms
  • Current smoker
  • Ex-smoker > 10 pack years -Significant co-morbidity due to condition other than asthma.-
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064869

Locations
United Kingdom
Regional Respiratory Centre, Belfast City Hospital
Belfast, Co Down, United Kingdom, BT 9 7AB
Sponsors and Collaborators
Belfast Health and Social Care Trust
Northern Ireland Research and Development Office
Investigators
Principal Investigator: Liam Heaney, MD Belfast Health and Social Care Trust
  More Information

No publications provided

Responsible Party: Dr. Liam Heaney, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01064869     History of Changes
Other Study ID Numbers: 05/NIR/03/32
Study First Received: February 8, 2010
Last Updated: June 29, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Belfast Health and Social Care Trust:
Adherence
Asthma
medication

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 17, 2012