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An Online Intervention to Address Barriers to IBD Medication Adherence

NCT01852097 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2013-05-13

No results posted yet for this study

Summary

Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory conditions that usually affect the colon and the small intestine. Between 30 to 45% of patients with IBD do not take their treatment as prescribed by their health care team (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA) provides a theoretical framework to develop adherence interventions that are patient-centred (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the medication but there are barriers beyond their control, such as not understanding the instructions (practical barriers). Intentional non-adherence is the result of the beliefs affecting the patient's motivation to continue with treatment (perceptual barriers).

Aims

1. To develop an internet-based intervention to address perceptual and practical barriers to adherence to medicine for IBD.
2. To determine whether the intervention is effective based on change in both types of barriers.

Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD; currently prescribed azathioprine, mesalazine, and/or adalimumab.

240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will take part in the study. An online pilot Randomised Controlled Trial will allocate the participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or Treatment as Usual group. On first visiting the website, participants will be screened for eligibility and asked for consent before answering the questionnaires. The website will assign intervention modules to be completed based on an individual's profile.

Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month follow-ups.

Potential Impact A CBT based online intervention tailored to personal needs and concerns may benefit a large number of patients with low costs for the national healthcare services. A website can be accessed at a time and place convenient to the patient.

Conditions

  • Inflammatory Bowel Disease (IBD)

Interventions

BEHAVIORAL

CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.

The general approach to the intervention is the following: 1. Assess and profile individual perceptual and practical barriers to medication for IBD using validated questionnaires. 2. Give feedback to individuals on their questionnaire responses. 3. Provide individualised advice to address doubts, misconceptions and concerns for currently prescribed medications. 4. Provide advice on overcoming practical barriers. 5. Send motivational messages (and reminders if applicable) by email or text based on the unique profile of each participant. 6. Provide information about how to raise concerns with medical practitioners and how to get the most from a medical consultation.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-11-30
Completion
2014-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852097 on ClinicalTrials.gov