Clinical trial NCT01852097: An Online Intervention to Address Barriers to IBD Medication Adherence
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: Inflammatory Bowel Disease (IBD)
Crohn's disease
Ulcerative colitis
Cognitive Behavioural Therapy (CBT)
Medication adherence
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Beliefs about Medicines Questionnaire (BMQ)
timeFrame: Baseline, 1 month follow-up, 3 month follow-up
Secondary outcomes:
measure: Change in Medication Adherence Report Scale (MARS)
timeFrame: Baseline, 1 month follow-up, 3 month follow-up
measure: Change in Hospital Anxiety and Depression questionnaire (HADS)
timeFrame: Baseline, 1 month follow-up, 3 month follow-up
measure: Change in Visual Analogue measure of adherence
timeFrame: Baseline, 1 month follow-up, 3 month follow-up.
measure: Change in Brief Illness Perception Questionnaire (IPQ)
timeFrame: Baseline, 1 month follow-up, 3 month follow-up.
measure: Change in Satisfaction with Information about Medicines Scale (SIMS)
timeFrame: Baseline, 1 month follow-up, 3 month follow-up
measure: Change in Marlow-Crowne Social Desirability Scale-Form C (M-C Form C) (Reynolds 1982)
timeFrame: Baseline, 1 month follow-up, 3 month follow-up
measure: Change in Short Inflammatory Bowel Disease Questionnaire
timeFrame: Baseline, 1 month follow-up, 3 month follow-up
Other outcomes:
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