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Trial registered on ANZCTR


Registration number
ACTRN12616000087459
Ethics application status
Approved
Date submitted
22/01/2016
Date registered
27/01/2016
Date last updated
27/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Paediatric-to-adult transition and medication adherence in patients with inflammatory bowel disease
Scientific title
Paediatric-to-adult transition and medication adherence in patients with inflammatory bowel disease (IBD): effect of a drug counselling session with an experienced IBD pharmacist
Secondary ID [1] 288392 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 297398 0
Condition category
Condition code
Oral and Gastrointestinal 297587 297587 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.
A further questionnaire will be given out 6 months after the baseline questionnaire to determine the effectiveness of the intervention.
Intervention code [1] 293699 0
Behaviour
Intervention code [2] 293700 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] 297131 0
Change in adherence assessed by the Medication Adherence Rate Scale(MARS) score
Timepoint [1] 297131 0
0, 6 months
Secondary outcome [1] 320115 0
Change in medication necessity as determined by Beliefs about medications questionnaire (BMQ)
Timepoint [1] 320115 0
0, 6 months
Secondary outcome [2] 320116 0
Change in medication concerns as determined by Beliefs about medications questionnaire (BMQ)
Timepoint [2] 320116 0
0, 6 months

Eligibility
Key inclusion criteria
Confirmed diagnosis of IBD
Minimum age
12 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients without a definite diagnosis of IBD and those not prescribed IBD medications (for example, following resectional surgery) were excluded.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5111 0
Westmead Hospital - Westmead
Recruitment hospital [2] 5112 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 5113 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 5114 0
Norwest Private Hospital - Bella Vista
Recruitment postcode(s) [1] 12575 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 12576 0
2145 - Westmead
Recruitment postcode(s) [3] 12577 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 292747 0
Hospital
Name [1] 292747 0
Dept of Gastroenterology and Liver Services, Concord Repatriation General Hospital
Address [1] 292747 0
Dept of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital Rd, Concord NSW 2139
Country [1] 292747 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] 291476 0
None
Name [1] 291476 0
Address [1] 291476 0
Country [1] 291476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294230 0
Sydney Children's Hospitals Network
Ethics committee address [1] 294230 0
Research and Development
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Ethics committee country [1] 294230 0
Australia
Date submitted for ethics approval [1] 294230 0
01/11/2013
Approval date [1] 294230 0
20/12/2013
Ethics approval number [1] 294230 0
LNR/13/SCHN/318
Ethics committee name [2] 294231 0
Sydney Local Health Destrict Human Research Ethics Committee - CRGH
Ethics committee address [2] 294231 0
Concord Repatriation General Hospital
Building 75, Hospital Road
Concord NSW 2139
Ethics committee country [2] 294231 0
Australia
Date submitted for ethics approval [2] 294231 0
Approval date [2] 294231 0
23/09/2011
Ethics approval number [2] 294231 0
LNR/11/CRGH/217
Ethics committee name [3] 294232 0
Western Sydney Local Health Destrict Human Research Ethics Committee
Ethics committee address [3] 294232 0
Room 1072, Level 1, Education Block, Westmead Hospital
Hawkesbury Road, Westmead NSW 2145
Ethics committee country [3] 294232 0
Australia
Date submitted for ethics approval [3] 294232 0
Approval date [3] 294232 0
12/09/2013
Ethics approval number [3] 294232 0
LNRSSA/13/WMEAD/319

Summary
Brief summary
Psychological factors are important in medication adherence. Interventions geared towards education may help facilitate 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 he 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 at 6 months after baseline questionnaires. The primary outcome was adherence measured by the MARS score. Secondary outcomes were medication necessity and concerns
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62982 0
Prof Rupert Leong
Address 62982 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital,Hospital Rd, Concord NSW 2139
Country 62982 0
Australia
Phone 62982 0
+61297676111
Fax 62982 0
+61297676767
Email 62982 0
rupert.leong@sswahs.nsw.gov.au
Contact person for public queries
Name 62983 0
Prof Rupert Leong
Address 62983 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital,Hospital Rd, Concord NSW 2139
Country 62983 0
Australia
Phone 62983 0
+61297676111
Fax 62983 0
+61297676767
Email 62983 0
rupert.leong@sswahs.nsw.gov.au
Contact person for scientific queries
Name 62984 0
Prof Rupert Leong
Address 62984 0
Department of Gastroenterology and Liver Services
Concord Repatriation General Hospital
Hospital,Hospital Rd, Concord NSW 2139
Country 62984 0
Australia
Phone 62984 0
+61297676111
Fax 62984 0
+61297676767
Email 62984 0
rupert.leong@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary