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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01117493
Other study ID # 06054JB-A
Secondary ID
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


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
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