A Nurse Led Programme to Improve Adherence in Difficult Asthma

NCT01064869 | Completed

• 1 other identifier: 05/NIR/03/32
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Asthma

Keywords

Adherence; Asthma; medication

Outcome Measures

Primary Outcomes (1)

• Adherence to Inhaled combination therapy

  6 months

Secondary Outcomes (5)

• Asthma control score

  6 months

• Asthma Quality of Life Questionnaire

  6 months

• Hospital anxiety and depression scale

  6 months

• Lung function

  6 months

• Reduction in rescue courses of Steroids

  6 months

Study Arms (2)

Psycho-educational intervention

EXPERIMENTAL

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

usual care

NO INTERVENTION

Standard asthma management

Interventions

Pyscho-behavioural BEHAVIORAL

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

Psycho-educational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (1)

Regional Respiratory Centre, Belfast City Hospital

Belfast, Co Down, BT 9 7AB, United Kingdom

Location

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

• Liam Heaney, MD

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: January 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

GB (1)