Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117493
• Other study ID #: 06054JB-A
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: May 4, 2010
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2010
• Source: Belfast Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust	University of Ulster

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Lung function	Spirometric measurement of FEV1 expressed as a percentage predicted is used to assess lung function	8 months	No
Secondary	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	No