An Online Intervention to Address Barriers to IBD Medication Adherence
A Pilot Randomised Controlled Trial to Determine the Feasibility, Acceptability and Effectiveness of a CBT Based Online Intervention to Address Practical and Perceptual Barriers to Medication Adherence in Inflammatory Bowel Disease.
1 other identifier
interventional
240
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMay 13, 2013
February 1, 2013
6 months
October 11, 2012
May 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Beliefs about Medicines Questionnaire (BMQ)
The BMQ (Horne and Weinman, 1999) has been validated for use with people with chronic conditions. It comprises a scale that measures beliefs about medication prescribed specifically for IBD and a general scale that evaluates beliefs that medicines are harmful, addictive, poisons.
Baseline, 1 month follow-up, 3 month follow-up
Secondary Outcomes (7)
Change in Medication Adherence Report Scale (MARS)
Baseline, 1 month follow-up, 3 month follow-up
Change in Hospital Anxiety and Depression questionnaire (HADS)
Baseline, 1 month follow-up, 3 month follow-up
Change in Visual Analogue measure of adherence
Baseline, 1 month follow-up, 3 month follow-up.
Change in Brief Illness Perception Questionnaire (IPQ)
Baseline, 1 month follow-up, 3 month follow-up.
Change in Satisfaction with Information about Medicines Scale (SIMS)
Baseline, 1 month follow-up, 3 month follow-up
- +2 more secondary outcomes
Study Arms (2)
CBT based online intervention
EXPERIMENTALCBT based online intervention to elicit and address perceptual and practical barriers to taking medication.
Control group
NO INTERVENTIONCare as Usual. Participants in the control group will be able to access the online intervention after they complete their last follow-up questionnaire.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18 or over.
- Diagnosis of IBD (Crohn's Disease or Ulcerative Colitis or Indeterminate Colitis).
- Currently prescribed one or more of the following medications for IBD: azathioprine, mesalazine, and adalimumab.
You may not qualify if:
- We will exclude people who are for any reason unable to make an informed decision about taking part and people who do not wish to complete follow-up questionnaires.
- People who declare that they do not understand written English. This is a pilot feasibility study that aims to assess the effectiveness and acceptability of an online CBT based intervention in English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PMID: 40243391DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2012
First Posted
May 13, 2013
Study Start
May 1, 2013
Primary Completion
November 1, 2013
Study Completion
January 1, 2014
Last Updated
May 13, 2013
Record last verified: 2013-02