Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

This study has been completed.
Sponsor:
Collaborator:
University of Ulster
Information provided by:
Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01117493
First received: May 4, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

The aim of this exploratory randomized controlled trial was to investigate the efficacy of a disease specific Expert Patient Programme compared to usual care in patients with bronchiectasis. Hypothesis: Disease specific EPP will increase self efficacy compared to usual care.


Condition Intervention
Bronchiectasis
Behavioral: Expert Patient Programme
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

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

Primary Outcome Measures:
  • Self-efficacy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Self efficacy is measured using the Chronic Disease Self Efficacy Scale. Confidence is measured on a 1-10 point Likert scale for 10 subscales. There are no specific units for this measurement.


Secondary Outcome Measures:
  • Perception of illness [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Perception of illness is measured using the Illness Perception Questionnaire - revised IPQ-R. This questionnaire has 8 domains. Minimum score 52 and maximum 204. There are no specific units for this measurement.

  • Health related quality of life [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Health related quality of life is measured using the St Georges Respiratory Questionnaire. This questionnaire has 3 domains. Min-max scores 0-100%

  • Self rated health [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    An expert patient programme questionnaire is used to record self rated health, management of condition, days lost to work and social activities, satisfaction and benefits. There are no specific units for this measurement.

  • Lung function [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Spirometric measurement of FEV1 expressed as a percentage predicted is used to assess lung function

  • Rate of exacerbation [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Frequency of antibiotics is recorded to assess rate of exacerbation. These will be expressed as the number of antibiotics prescribed per group during the study.


Enrollment: 64
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual care
Usual care included reviews at a specialist respiratory clinic on a three monthly basis to monitor spirometry, inflammatory blood markers and sputum microbiology. The patients were prescribed inhaled therapy and antibiotics if required, and treatment adjusted to the needs of the patient as necessary, including hospital admission.
Behavioral: Usual care
Usual care included reviews at a specialist respiratory clinic on a three monthly basis to monitor spirometry, inflammatory blood markers and sputum microbiology. The patients were prescribed inhaled therapy and antibiotics if required, and treatment adjusted to the needs of the patient as necessary, including hospital admission.
Other Name: Usual management
Experimental: Expert Patient Programme
Receives a disease specific Expert Patient Programme in addition to usual care. The disease specific Expert Patient Programme was delivered one session per week (lasting 2½ hours) for eight weeks and included 2 weeks disease specific education followed by 6 weeks standardised Expert Patient Programme.
Behavioral: Expert Patient Programme
Intervention was a disease specific Expert Patient Programme in addition to usual care. The disease specific Expert Patient Programme was delivered one session per week (lasting 2½ hours) for eight weeks and included 2 weeks disease specific education followed by 6 weeks standardised Expert Patient Programme.
Other Name: Self-management

  Eligibility

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

Inclusion Criteria:

  • Adult patients (>18 years) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomography scan were included in the study

Exclusion Criteria:

  • Primary diagnosis of cystic fibrosis
  • Patients with methicillin-resistant Staphylococcus aureus infection
  • Patients with any condition that would have an impact on the assessment procedures (e.g. sensory impairment, pregnancy, language barriers)
  • Any factor that would prevent adherence to the self-management programme.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01117493

Sponsors and Collaborators
Belfast Health and Social Care Trust
University of Ulster
Investigators
Principal Investigator: Judy M Bradley, PhD Belfast Health and Social Care Trust & University of Ulster
  More Information

No publications provided

Responsible Party: Dr Judy Bradley, Belfast Health and Social Care TRust
ClinicalTrials.gov Identifier: NCT01117493     History of Changes
Other Study ID Numbers: 06054JB-A
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014