Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Behavioral: Usual care; Behavioral: Expert Patient Programme

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: 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 Names: Self-management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	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.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of illness	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.	8 months
Health related quality of life	Health related quality of life is measured using the St Georges Respiratory Questionnaire. This questionnaire has 3 domains. Min-max scores 0-100%	8 months
Self rated health	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.	8 months
Lung function	Spirometric measurement of FEV1 expressed as a percentage predicted is used to assess lung function	8 months
Rate of exacerbation	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.	8 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Estimate): May 5, 2010
• Last Update Submitted That Met QC Criteria: May 4, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 06054JB-A