Paediatric-to-adult transition and medication adherence in patients with inflammatory bowel disease

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000087459

Enrollment

126

Registered

2016-01-27

Start date

2014-04-12

Completion date

2014-12-17

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

12 Years to 25 Years

Healthy volunteers

Inclusion criteria

Confirmed diagnosis of IBD

Exclusion criteria

Patients without a definite diagnosis of IBD and those not prescribed IBD medications (for example, following resectional surgery) were excluded.

Outcome results