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A Nurse Led Programme to Improve Adherence in Difficult Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064869
First Posted: February 9, 2010
Last Update Posted: March 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Liam Heaney, Belfast Health and Social Care Trust
  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 (Participant)
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

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

Primary Outcome Measures:
  • Adherence to Inhaled combination therapy [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Asthma control score [ Time Frame: 6 months ]
  • Asthma Quality of Life Questionnaire [ Time Frame: 6 months ]
  • Hospital anxiety and depression scale [ Time Frame: 6 months ]
  • Lung function [ Time Frame: 6 months ]
  • Reduction in rescue courses of Steroids [ Time Frame: 6 months ]

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Liam Heaney, MD Belfast Health and Social Care Trust
  More Information

Responsible Party: Liam Heaney, Doctor, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01064869     History of Changes
Other Study ID Numbers: 05/NIR/03/32
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: March 15, 2016
Last Verified: March 2016

Keywords provided by Liam Heaney, 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