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Completed

NCT Number: NCT01117493

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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Self-management

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.

Other names: Usual management

Primary outcomes

  1. Self-efficacy

    Time frame: 8 months

    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 outcomes

  1. Perception of illness

    Time frame: 8 months

    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.

  2. Health related quality of life

    Time frame: 8 months

    Health related quality of life is measured using the St Georges Respiratory Questionnaire. This questionnaire has 3 domains. Min-max scores 0-100%

  3. Self rated health

    Time frame: 8 months

    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.

  4. Lung function

    Time frame: 8 months

    Spirometric measurement of FEV1 expressed as a percentage predicted is used to assess lung function

  5. Rate of exacerbation

    Time frame: 8 months

    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.

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Collaborators

  • University of Ulster

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 5, 2010
Registry last updated
May 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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