Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

NCT01117493 | Completed

• 1 other identifier: 06054JB-A
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Perception of illness

  8 months

• Health related quality of life

  8 months

• Self rated health

  8 months

• Lung function

  8 months

• Rate of exacerbation

  8 months

Study Arms (2)

Usual care

OTHER

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

Expert Patient Programme

EXPERIMENTAL

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

Interventions

Expert Patient Programme BEHAVIORAL

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.

Also known as: Self-management

Expert Patient Programme

Usual care BEHAVIORAL

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.

Also known as: Usual management

Usual care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• University of Ulster: collaborator

MeSH Terms

Conditions

Bronchiectasis

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Judy M Bradley, PhD

  Belfast Health and Social Care Trust & University of Ulster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: September 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 5, 2010

Record last verified: 2010-04