Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000094471
Ethics application status
Approved
Date submitted
15/01/2016
Date registered
29/01/2016
Date last updated
29/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long term impact of targeted drug counselling intervention on medication adherence in Inflammatory Bowel Disease patients
Scientific title
Long term impact of targeted drug counselling intervention on medication adherence in Inflammatory Bowel Disease patients
Secondary ID [1] 288331 0
Nil Known
Universal Trial Number (UTN)
U1111-1178-5327
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 297307 0
Condition category
Condition code
Oral and Gastrointestinal 297507 297507 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are given two screening questionnaires to determine if they are adherers or non-adherers
The Medication Adherence Rating Scale (MARS) is a validated questionnaire that represents medication adherence comprising of 4 simple questions. A score below 17 represents medication non-adherence.
The Beliefs about Medication Questionnaire (BMQ) is a validated questionnaire assessing a subjects perception of necessity of medications and concerns about medications. This questionnaire helps guide the direction of the counselling / educational intervention.
Patients identified as non-adherers are assigned to the intervention group and will receive a ONCE off personal (one on one) drug counselling session with an experienced IBD pharmacist lasting approximately 20 minutes.
Further questionnaires are given out on a 3 monthly basis to monitor for changes in adherence and to detemine the effectiveness of the intervention
Intervention code [1] 293628 0
Behaviour
Intervention code [2] 293646 0
Early detection / Screening
Comparator / control treatment
Patients who were screened with the two questionnaires and not assigned to the non-adherers group were assigned to the adherers group as a control.

Controls, as they have good adherence at baseline, do not require intervention. However, they will be followed up to ensure their adherence remains optimal.
Control group
Active

Outcomes
Primary outcome [1] 297065 0
Change in adherence assessed by the Medication Adherence Rate Scale(MARS) score
Timepoint [1] 297065 0
0, 3,6,9,12,15,18,21,24 months
Secondary outcome [1] 319947 0
Change in medication Acceptance as determined by Beliefs about medications questionnaire (BMQ)
Timepoint [1] 319947 0
0, 3,6,9,12,15,18,21,24 months
Secondary outcome [2] 319948 0
Change in medication necessity as determined by Beliefs about medications questionnaire (BMQ)
Timepoint [2] 319948 0
0, 3,6,9,12,15,18,21,24 months
Secondary outcome [3] 319949 0
Change in medication concerns as determined by Beliefs about medications questionnaire (BMQ)
Timepoint [3] 319949 0
0, 3,6,9,12,15,18,21,24 months

Eligibility
Key inclusion criteria
Confirmed diagnosis of IBD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not taking medications at the time of screening
Incomplete questionnaires at screening.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N./A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Non-adherers will receive the educational counselling.
Adherers do not require educational counselling as they already take their medication, but will be followed up to determine whether adherence is dynamic and changes over time.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Preliminary studies determined the Cohen’s effect size value to be (d=0.99) suggesting a large effect size difference between adherers and non-adherers. With a two-sided alpha level of 0.05, a sample size between 24 to 54 non-adherers was required to provide a statistical power of 80%. As non-adherence in IBD patients is approximately 35-45% , a target sample size of 120 was calculated to be sufficient to gather the required amount of non-adherent patients and adherers..

Missing data were replaced by the last-observation-carried-forward (LOCF) method for patients who could not be contacted or refused further follow up. All analyses were performed on the basis of the intention-to-treat principle. Non parametric test such as the Mann-Whitney test was used for continuous variables and chi-square test for categorical variables. Analyses were performed with SPSS software, version 20.0.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
12/10/2011
Date of last participant enrolment
Anticipated
Actual
21/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5050 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 5051 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 12537 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 12538 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 292695 0
Hospital
Name [1] 292695 0
Concord Repatriation General Hospital Dept of Gastroenterology and Liver Services
Country [1] 292695 0
Australia
Primary sponsor type
Individual
Name
Professor Rupert Leong
Address
Dept of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital Rd, Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 291421 0
None
Name [1] 291421 0
Address [1] 291421 0
Country [1] 291421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294175 0
Sydney Local Health District Human Research Ethics Committee - CRGH
Ethics committee address [1] 294175 0
Concord Repatriation General Hospital(CRGH)
Hospital Road
Concord NSW 2139
Ethics committee country [1] 294175 0
Australia
Date submitted for ethics approval [1] 294175 0
15/09/2011
Approval date [1] 294175 0
23/09/2011
Ethics approval number [1] 294175 0
11/217

Summary
Brief summary
Psychological factors are often underrepresented although important in medication adherence. Interventions geared towards education may help facilate adherence.

Two questionnaires were administered to screen IBD patients. The Medication Adherence Rating Scale (MARS) questionnaire screened for non-adherence and consisted of four questions on a Likert-type scale. The Beliefs about Medications Questionnaire (BMQ) addressed necessity and concerns. The BMQ consisted of ten questions on a 5-point Likert scale The first five questions addressed patient necessity towards medications and the last five questions addressed patient concerns regarding medications totalling a maximum of 25 points per domain. High necessity and concerns was determined with a score of >15/25 in each corresponding domain. Patients with MARS scores below 17 were classified as non-adherers and were offered a structured personalised counselling session with an IBD pharmacist addressing misperceptions, concerns, risk and other queries. Adherers were recruited as controls. All patients were followed up with the MARS and BMQ questionnaire on a three-monthly basis for a maximum of two years or until the study period had elapsed. The primary outcome was adherence measured by the MARS score. Secondary outcomes were medication necessity, concerns and acceptance. Medication acceptance was defined as high necessity >15/25 and low concerns score <16/25.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62778 0
Prof Rupert Leong
Address 62778 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital,Hospital Rd, Concord NSW 2139
Country 62778 0
Australia
Phone 62778 0
+61297676111
Fax 62778 0
+61297676767
Email 62778 0
[email protected]
Contact person for public queries
Name 62779 0
Prof Rupert Leong
Address 62779 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital,Hospital Rd, Concord NSW 2139
Country 62779 0
Australia
Phone 62779 0
+61297676111
Fax 62779 0
+61297676767
Email 62779 0
[email protected]
Contact person for scientific queries
Name 62780 0
Prof Rupert Leong
Address 62780 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital,Hospital Rd, Concord NSW 2139
Country 62780 0
Australia
Phone 62780 0
+61297676111
Fax 62780 0
+61297676767
Email 62780 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInflammatory Bowel Disease Pharmacist Adherence Counseling Improves Medication Adherence in Crohn's Disease and Ulcerative Colitis.2017https://dx.doi.org/10.1097/MIB.0000000000001194
N.B. These documents automatically identified may not have been verified by the study sponsor.