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Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expert Patient Programme
Usual care
Sponsored by
Belfast Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Usual care

    Expert Patient Programme

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 4, 2010
    Last Updated
    May 4, 2010
    Sponsor
    Belfast Health and Social Care Trust
    Collaborators
    University of Ulster
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01117493
    Brief Title
    Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis
    Official Title
    Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Belfast Health and Social Care Trust
    Collaborators
    University of Ulster

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiectasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Expert Patient Programme
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expert Patient Programme
    Other Intervention Name(s)
    Self-management
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual care
    Other Intervention Name(s)
    Usual management
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Self-efficacy
    Description
    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.
    Time Frame
    8 months
    Secondary Outcome Measure Information:
    Title
    Perception of illness
    Description
    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.
    Time Frame
    8 months
    Title
    Health related quality of life
    Description
    Health related quality of life is measured using the St Georges Respiratory Questionnaire. This questionnaire has 3 domains. Min-max scores 0-100%
    Time Frame
    8 months
    Title
    Self rated health
    Description
    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.
    Time Frame
    8 months
    Title
    Lung function
    Description
    Spirometric measurement of FEV1 expressed as a percentage predicted is used to assess lung function
    Time Frame
    8 months
    Title
    Rate of exacerbation
    Description
    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.
    Time Frame
    8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Judy M Bradley, PhD
    Organizational Affiliation
    Belfast Health and Social Care Trust & University of Ulster
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

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