A nurse-led intervention to enhance medication adherence in ulcerative colitis (UC) using a concordance-led consultation
| ISRCTN | ISRCTN67674151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67674151 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/04/2004
- Registration date
- 28/04/2004
- Last edited
- 07/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Greg Rubin
Scientific
Scientific
NoReN Office
The Health Centre
Sunningdale Drive
Eaglescliffe
Stockton-on-Tees
TS16 9EA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A nurse-led intervention to enhance medication adherence in ulcerative colitis (UC) using a concordance-led consultation |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2004 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 106 |
| Key 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'. |
| Key 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. |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NoReN Office
Stockton-on-Tees
TS16 9EA
United Kingdom
TS16 9EA
United Kingdom
Sponsor information
Northern Primary Care Research Network (NoReN) (UK)
Government
Government
The Health Centre
Sunningdale Drive
Eaglescliffe
Stockton-on-Tees
TS16 9EA
United Kingdom
Funders
Funder type
Industry
Procter and Gamble Pharmaceuticals (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/07/2017: No publications found in PubMed, verifying study status with principal investigator.
