An Online Intervention to Address Barriers to IBD Medication Adherence
Primary Purpose
Inflammatory Bowel Disease (IBD)
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease (IBD) focused on measuring Inflammatory Bowel Disease (IBD), Crohn's disease, Ulcerative colitis, Cognitive Behavioural Therapy (CBT), Medication adherence
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CBT based online intervention
Control group
Arm Description
CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.
Care as Usual. Participants in the control group will be able to access the online intervention after they complete their last follow-up questionnaire.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Medication Adherence Report Scale (MARS)
The MARS scale (Horne and Hankins 1997) is extensively used as a measure of adherent behaviours in a variant of illness populations. The MARS attempts to diminish the social pressure on patients to under-report non-adherence by phrasing adherence questions in a non-threatening manner and assuring them that responses are anonymous and confidential.
Change in Hospital Anxiety and Depression questionnaire (HADS)
The HADS scale (Zigmond and Snaith 1983) is a reliable and valid instrument for detecting states of depression and anxiety.
Change in Visual Analogue measure of adherence
Self-reported estimation of the % of medication taken over the last 4 weeks.
Change in Brief Illness Perception Questionnaire (IPQ)
The brief IPQ (Broadbent, Petrie et al. 2006) has demonstrated adequate test-retest reliability and validity.
Change in Satisfaction with Information about Medicines Scale (SIMS)
The SIMS scale (Horne, Hankins et al. 2001) is a valid and reliable instrument for assessing how well the needs for medicines information in patient are being covered.
Change in Marlow-Crowne Social Desirability Scale-Form C (M-C Form C) (Reynolds 1982)
The Marlow-Crowne Social Desirability Scale-Form C (Reynolds 1982) is a measure of social desirability as a response tendency and it has been proved reliable and consistent (Nordholm 1974; Crino, Rubenfeld et al. 1985; Barger 2002).
Change in Short Inflammatory Bowel Disease Questionnaire
The SIBDQ is a valid and reliable tool able to detect meaningful clinical changes in the health related quality of life of individuals with both Crohn's disease and Ulcerative colitis. It measures physical, social, and emotional status (the scores go from 10 to 70, poor to good quality of life).
Full Information
NCT ID
NCT01852097
First Posted
October 11, 2012
Last Updated
May 10, 2013
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT01852097
Brief Title
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
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
To develop an internet-based intervention to address perceptual and practical barriers to adherence to medicine for IBD.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease (IBD)
Keywords
Inflammatory Bowel Disease (IBD), Crohn's disease, Ulcerative colitis, Cognitive Behavioural Therapy (CBT), Medication adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT based online intervention
Arm Type
Experimental
Arm Description
CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Care as Usual. Participants in the control group will be able to access the online intervention after they complete their last follow-up questionnaire.
Intervention Type
Behavioral
Intervention Name(s)
CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.
Intervention Description
The general approach to the intervention is the following:
Assess and profile individual perceptual and practical barriers to medication for IBD using validated questionnaires.
Give feedback to individuals on their questionnaire responses.
Provide individualised advice to address doubts, misconceptions and concerns for currently prescribed medications.
Provide advice on overcoming practical barriers.
Send motivational messages (and reminders if applicable) by email or text based on the unique profile of each participant.
Provide information about how to raise concerns with medical practitioners and how to get the most from a medical consultation.
Primary Outcome Measure Information:
Title
Change in Beliefs about Medicines Questionnaire (BMQ)
Description
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.
Time Frame
Baseline, 1 month follow-up, 3 month follow-up
Secondary Outcome Measure Information:
Title
Change in Medication Adherence Report Scale (MARS)
Description
The MARS scale (Horne and Hankins 1997) is extensively used as a measure of adherent behaviours in a variant of illness populations. The MARS attempts to diminish the social pressure on patients to under-report non-adherence by phrasing adherence questions in a non-threatening manner and assuring them that responses are anonymous and confidential.
Time Frame
Baseline, 1 month follow-up, 3 month follow-up
Title
Change in Hospital Anxiety and Depression questionnaire (HADS)
Description
The HADS scale (Zigmond and Snaith 1983) is a reliable and valid instrument for detecting states of depression and anxiety.
Time Frame
Baseline, 1 month follow-up, 3 month follow-up
Title
Change in Visual Analogue measure of adherence
Description
Self-reported estimation of the % of medication taken over the last 4 weeks.
Time Frame
Baseline, 1 month follow-up, 3 month follow-up.
Title
Change in Brief Illness Perception Questionnaire (IPQ)
Description
The brief IPQ (Broadbent, Petrie et al. 2006) has demonstrated adequate test-retest reliability and validity.
Time Frame
Baseline, 1 month follow-up, 3 month follow-up.
Title
Change in Satisfaction with Information about Medicines Scale (SIMS)
Description
The SIMS scale (Horne, Hankins et al. 2001) is a valid and reliable instrument for assessing how well the needs for medicines information in patient are being covered.
Time Frame
Baseline, 1 month follow-up, 3 month follow-up
Title
Change in Marlow-Crowne Social Desirability Scale-Form C (M-C Form C) (Reynolds 1982)
Description
The Marlow-Crowne Social Desirability Scale-Form C (Reynolds 1982) is a measure of social desirability as a response tendency and it has been proved reliable and consistent (Nordholm 1974; Crino, Rubenfeld et al. 1985; Barger 2002).
Time Frame
Baseline, 1 month follow-up, 3 month follow-up
Title
Change in Short Inflammatory Bowel Disease Questionnaire
Description
The SIBDQ is a valid and reliable tool able to detect meaningful clinical changes in the health related quality of life of individuals with both Crohn's disease and Ulcerative colitis. It measures physical, social, and emotional status (the scores go from 10 to 70, poor to good quality of life).
Time Frame
Baseline, 1 month follow-up, 3 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Sibelli, MSc. Health Psychology
Phone
+44(0)20 7874 1282
Email
a.sibelli@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Rob Horne, Prof. of Behavioural Medicine
Phone
+44 (0)20 7874 1281
Email
r.horne@ucl.ac.uk
12. IPD Sharing Statement
Links:
URL
http://www.ucl.ac.uk/jro
Description
Sponsor
URL
http://www.ucl.ac.uk/pharmacy
Description
UCL School of Pharmacy official website
Learn more about this trial
An Online Intervention to Address Barriers to IBD Medication Adherence
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