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CompletedNCT01117493Updated May 5, 2010

Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

An interventional study of Expert Patient Programme and Usual care in Bronchiectasis, sponsored by Belfast Health and Social Care Trust. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-05.

Sponsored by Belfast Health and Social Care Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchiectasis

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03

In context

Bronchiectasis

373 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's enrollment of 64 is close to the median of 59 across 238 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Belfast Health and Social Care Trust is the lead sponsor of 45 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Other
    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.

    Behavioral: Usual care

  • Experimental
    Expert Patient Programme

    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

  • BehavioralExpert 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.

    Also known as: Self-management

  • BehavioralUsual 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.

    Also known as: Usual management

06

What researchers measure

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.

    Time frame: 8 months

Secondary outcomes

  1. 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.

    Time frame: 8 months

  2. 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%

    Time frame: 8 months

  3. 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.

    Time frame: 8 months

  4. Lung function

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

    Time frame: 8 months

  5. 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.

    Time frame: 8 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2006, a primary completion of Oct 2007 and a completion of Oct 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2010
First posted
May 5, 2010
Start
Sep 2006
Primary completionActual
Oct 2007
CompletionActual
Oct 2007
Last update
May 5, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01117493
Lead sponsor
Belfast Health and Social Care Trust
Collaborators
University of Ulster
First posted
May 5, 2010
Start date
Sep 2006
Primary completion
Oct 2007
Completion
Oct 2007
Last update
May 5, 2010

Study contacts

Judy M Bradley, PhD
principal investigator · Belfast Health and Social Care Trust & University of Ulster

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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