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Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

13. februar 2009 opdateret af: University Hospitals, Leicester

Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.

Ulcerative Colitis is associated with a significantly increased risk of colorectal cancer. This risk can be reduced through regular medication with 5ASA compounds. Their effectiveness however is limited by poor adherence to the treatment protocols by many patients.

The hypothesis which underlies this proposal is that if the factors responsible for poor compliance can be identified, interventions could be developed which would help to overcome the barriers which exist in individual patients. These interventions would be based on the reasons for non-adherence, specifically tailored to the needs of the individual. As a result such interventions will improve patients' adherence with prescribed 5ASA and therefore reduce the relapses of the disease and a cancer risk.

Studieoversigt

Status

Ukendt

Betingelser

Colitis ulcerosa

Intervention / Behandling

Adfærdsmæssigt: Range of electronic pill dispensers with alarms

Detaljeret beskrivelse

Poor adherence to treatment is well recognised and significantly contributes to treatment failures. In ulcerative colitis it may be associated with an increased risk of colorectal cancer. Estimates for non-adherence range from 15% to 93% with an average of around a third of patients failing to adhere to their recommended therapeutic regimen.

The study aims to evaluate a wide-ranging approach to reducing poor adherence, which is based on factors associated with non-adherence and involves the patient in choosing interventions.

The effectiveness of the overall intervention will be assessed through a randomised controlled trial comparing intervention against standard care.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 3

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Male and female patients aged 18-80.
Those in whom a diagnosis of ulcerative colitis is based on histological confirmation of the disease.
Patients who are on daily maintenance therapy with 5 ASA medication.
Patients who have read the information leaflet and voluntarily given informed consent.

Exclusion Criteria:

Those aged under 18 years old.
Those with a diagnosis of Crohn's disease.
Patients not on regular 5ASA compound as maintenance therapy.
Patients unable to give informed consent.
Patients who do not wish to participate in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Støttende pleje
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Levels of patient adherence to therapy will be assessed in two ways: Tidsramme: 1 year	1 year
through pill counts and measurement of salicylate levels in urine samples. Tidsramme: 1 year	1 year

Sekundære resultatmål

Resultatmål	Tidsramme
Quantitative data will be collected through feedback from patients. Tidsramme: 1 year	1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospitals, Leicester

Efterforskere

Ledende efterforsker: John F Mayberry, DScMD, University Hospitals, Leicester

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. december 2007

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Forventet)

1. april 2009

Datoer for studieregistrering

Først indsendt

13. november 2006

Først indsendt, der opfyldte QC-kriterier