Clinical Pharmacist Role in Increasing the Adherence to Recommendations Among Patients Using Isotretinoin: A Randomized, Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- Knowledge
Study Overview
Brief Summary
The objective of the study was to evaluate the role of clinical pharmacists in improving adherence to medication and the recommendations related to isotretinoin, awareness about proper use, dealing with the side effects, and anxiety and depressive symptoms. Patients were randomly assigned to an intervention group (received the educational process (recommendations) about isotretinoin by a clinical pharmacist in addition to the routine education about isotretinoin provided by the physician) and a control group (received only the routine education about isotretinoin provided by the physician) and then followed for three months. Patient's adherence to the recommendations, patient's knowledge about isotretinoin, and side effects management for both groups were measured through a set of questions adapted from a validated questionnaire at baseline and after three months. Adherence scale was used to evaluate adherence to the medication after three months. Hospital Anxiety and Depression Scale were used to assess depressive and anxiety symptoms at baseline and at follow-up in each group.
Detailed Description
Patients and Settings
Patients who attended dermatological clinics (at King Abdullah University Hospital (KAUH), Princess Basma Hospital (PBH), and Prince Rashid Hospital (PRH). The study was conducted over the period from September/2020 to February/2021) to receive isotretinoin medication, with any brand names known in Jordan like (ISOSUPRA®, ROACCUTANE®, CURANCE®, RUATINE®,) and met the inclusion criteria were approached and asked to participate in the study. The following are the inclusion criteria:
- Male or female patients aged 18 years or older who were using isotretinoin.
- Patients with a current diagnosis of moderate to severe acne vulgaris.
- Patients who were on or going to receive standard isotretinoin doses (0.5-1mg/kg/day).
- Patients who were willing to participate in the study and to do a follow-up.
Patients with any contraindication to isotretinoin who cannot take the medication and patients who were not willing to participate in the study were excluded as explained in the following:
- Pregnant women and women who intend to become pregnant.
- Breastfeeding women.
- Presence of any renal or hepatic compromise or any pre-existing hyperlipidemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female patients aged 18 years or older who were using isotretinoin.
- •Patients with a current diagnosis of moderate to severe acne vulgaris.
- •Patients who were on or going to receive standard isotretinoin doses (0.5-1mg/kg/day).
- •Patients who were willing to participate in the study and to do a follow-up.
Exclusion Criteria
- •Pregnant women and women who intend to become pregnant.
- •Breastfeeding women.
- •Presence of any renal or hepatic compromise or any pre-existing hyperlipidemia.
- •Patients who were not willing to participate in the study.
Arms & Interventions
Intervention
received the educational process (recommendations) about isotretinoin by a clinical pharmacist in addition to the routine education about isotretinoin provided by the physician
Intervention: Education (Other)
Control
received only the routine education about isotretinoin provided by the physician
Outcomes
Primary Outcomes
Knowledge
Time Frame: 3 months
The patient knowledge section consisted of ten different questions/items, and each item had two answers (yes/no). Items were coded according to the answer; the correct (adequate) answer was coded as one (1), while the wrong (not adequate) answer was coded as zero (0). So, the knowledge score could take the values of 0 (no knowledge) to 10 (perfect knowledge).
Adherence to the Recommendations
Time Frame: 3 months
10 items for all patients, and each item had answers (yes/no). Items were coded according to the answer; the correct (adherent) answer was coded as one (1), while the wrong (not adherent) answer was coded as zero (0). The adherence score of patients 'compliance with the recommendations ranged between 0 (least adherent) to 10 (most adherent).
Secondary Outcomes
- HADS(3 MONTHS)
Investigators
Bushra Mahmoud Ahmad Hijazi
Assistant Professor
Jordan University of Science and Technology