Condition category
Digestive System
Date applied
14/04/2004
Date assigned
28/04/2004
Last edited
20/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Greg Rubin

ORCID ID

Contact details

NoReN Office
The Health Centre
Sunningdale Drive
Eaglescliffe
Stockton-on-Tees
TS16 9EA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A nurse-led intervention to enhance medication adherence in ulcerative colitis (UC) using a concordance-led consultation

Acronym

Study hypothesis

Concordance is an effective way of prescribing medicines based upon a partnership approach between the prescriber and patient. Patient preferences, beliefs and experiences are explored as part of the consultation in order to reach an agreement about how the patient can take their medicines effectively.

We would like to know whether a consultation based on these principles and delivered by a specialist nurse results in increased adherence with maintenance medication for patients with ulcerative colitis who are not currently adherent. We are also interested in whether change in medication adherence also results in improved quality of life, reduced disease activity and reduced number of relapses for patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ulcerative colitis

Intervention

Intervention:
A nurse-led consultation lasting a minimum of 30 minutes. Patients beliefs and attitudes to medication adherence are discussed, strategies developed to increase adherence and information and support regarding management of their ulcerative colitis will be offered. The intervention will be delivered using a concordance-led consultation.

Control:
No intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The proportion of patients in the subject and control groups for whom an increase in adherence with medication is observed. Adherence will be calculated as the percentage of dispensed medications that have been used with adherence defined as taking more than 4 months supply in 6-month period. Adherence therefore is measured as a dichotomous variable (adherent yes/no).

Secondary outcome measures

Changes in IBD-specific quality of life, disease activity and relapse rates in both subject and control groups throughout the 6-month follow-up period. Additional explanatory variables are: illness perception (IPQ-R), beliefs about medicines (BMQ), self reported medication adherence, preferred role in the decision making process (Degner) and the demographic variables previously outlined.

Overall trial start date

01/06/2004

Overall trial end date

01/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adults aged over 16 years with a diagnosis of ulcerative colitis (histologically proven), whose disease has been present for at least one year and who are found, from prescribing records, to be taking aminosalicylate (ASA) therapy at suboptimal levels (defined as using anything less than 8 months supply of aminosalicylates in a 12 month period). Patients who have been specifically told to stop taking their 5ASA medication will be screened out at the stage of initial patient invitation. Eligible patients who subsequently undergo total colectomy and therefore no longer require 5ASA therapy will no longer be eligible for inclusion in the study and will be classified as 'drop-out'.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

106

Participant exclusion criteria

Patients with self-limiting colitis or those whose UC has been diagnosed in the past year will be excluded. Patients aged less than 16 years are not eligible for inclusion and patients with significant neurological impairment such that they could not participate in the consultation will also be excluded.

Recruitment start date

01/06/2004

Recruitment end date

01/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NoReN Office
Stockton-on-Tees
TS16 9EA
United Kingdom

Sponsor information

Organisation

Northern Primary Care Research Network (NoReN) (UK)

Sponsor details

The Health Centre
Sunningdale Drive
Eaglescliffe
Stockton-on-Tees
TS16 9EA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Procter and Gamble Pharmaceuticals (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes