Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis
4. maj 2010 opdateret af: Belfast Health and Social Care Trust
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
64
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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.
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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.
Andre navne:
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Eksperimentel: 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.
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-efficacy
Tidsramme: 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.
|
8 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perception of illness
Tidsramme: 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.
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8 months
|
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Health related quality of life
Tidsramme: 8 months
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Health related quality of life is measured using the St Georges Respiratory Questionnaire.
This questionnaire has 3 domains.
Min-max scores 0-100%
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8 months
|
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Self rated health
Tidsramme: 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.
|
8 months
|
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Lung function
Tidsramme: 8 months
|
Spirometric measurement of FEV1 expressed as a percentage predicted is used to assess lung function
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8 months
|
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Rate of exacerbation
Tidsramme: 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.
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8 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Judy M Bradley, PhD, Belfast Health and Social Care Trust & University of Ulster
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. oktober 2007
Studieafslutning (Faktiske)
1. oktober 2007
Datoer for studieregistrering
Først indsendt
4. maj 2010
Først indsendt, der opfyldte QC-kriterier
4. maj 2010
Først opslået (Skøn)
5. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. maj 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2010
Sidst verificeret
1. april 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06054JB-A
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .