Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05839223 |
| Other study ID # |
IsoJordanUST |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
February 20, 2021 |
Study information
| Verified date |
April 2023 |
| Source |
Jordan University of Science and Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
The patients were informed about the study objectives, and their voluntary participation, and
that withdrawal from the study was possible at any time.
Ethical approval in accordance with regulations was obtained. Institutional Review Board
approval was obtained from the IRB at Jordan University of Science and Technology on
27/08/2020. The IRB reference number is (16/134/2020). Patients were asked to sign an
informed consent before participating. Participants' privacy was maintained and participants'
answers were kept strictly confidential and were never linked to any personal details.
Study Sample and Randomization
The sample size was calculated by OpenEpi, Version 3, open-source calculator-SSCohort/ RCT.
The following assumptions were employed: 30% effect size (difference in adherence to
recommendation between control (50%) and intervention group (80%)), alpha= 0.05, beta=0.8,
and enrollment ratio=1. Accordingly, the minimum sample size of patients needed was 45
patients in each group. In order to adjust for any dropout and to increase the statistical
power, the sample size was increased to 200 participants (100 in each group). Enrolled
patients were randomized at a ratio of 1:1 using a simple envelope method by flipping a coin.
Data collection
After the informed consent was taken from each patient agreed to participate, the clinical
pharmacist measured the level of knowledge about the drug for both groups and measured
anxiety and depression score (HADS) at baseline. Then, the participants were randomly
assigned to either an intervention group or a control group. Education (recommendations) on
isotretinoin was provided by clinical pharmacists to participants in the intervention group
only. Both groups received usual routine care (education on isotretinoin provided by a
physician). Both patients and the treating physicians were unaware of the assignment to
intervention and control groups. Then after three months, a phone call was made to each
patient in both groups to measure the extent of knowledge of the drug, the patients'
adherence to the drug and the recommendations for appropriate management of side effects,
anxiety, and depression score.
Clinical Pharmacist's Role in Study
The first task of the clinical pharmacist was to interview the patients at baseline for both
groups to get their responses on the questionnaires of knowledge, and the Hospital Anxiety
and Depression Scale (HADS). Second, to educate patients in the intervention group. The
education included: the degree of the importance of adherence to the drug and the
recommendations, the correct method of taking it, the importance of doing periodic laboratory
tests, common side effects, how to properly avoid and deal with side effects, precaution
warnings they should pay attention to, and what are the cases in which the drug should be
stopped.
Third, the clinical pharmacist distributed brochures in Arabic that contain the most
important points about the medication. Finally, after three months, she called all the
patients in both groups to get their responses on knowledge about isotretinoin, HADS, and
adherence to the medication and recommendations.
Study Questionnaires
The baseline questionnaire was administered in the waiting room of the dermatological clinic,
there was no one else present during the interview. The interviewer made sure that the
patients understood the questions before answering them. If the patient did not understand a
question, the interviewer explained it to him/her. A single interview lasted for
approximately 20 - 25 min.
The follow-up questionnaire was administered via phone call. The interviewer confirmed that
the patient understood all the questions before answering them. If the patient did not
understand a question, the interviewer explained it to him/her. A single interview lasted for
approximately 15- 20 min.
Data analysis
After data was collected, the data was entered into Excel worksheets. The responses were
coded and entered into SPSS (version 23). Per protocol analysis was used. Descriptive
statistics of categorical and continuous variables were calculated. For the categorical
variables, the frequency and percentage were calculated, while the arithmetic mean and
standard deviation were calculated for continuous variables.
The differences in participants' responses were examined using the Chi-square test (between
intervention and control groups) and McNamara's test (between baseline and follow up
encounters) for categorical dependent variables as appropriate. For continuous dependent
variables, One Way Analysis of Variance (ANOVA) test, independent samples t-test, and
Wilcoxon test were performed when applicable. Both Kolmogorov-Smirnov Z and Shapiro-Wilk
tests were used to test for normality of continuous variables. The statistical significance
level was considered at a p-value ≤ 0.05.
The degree of knowledge and awareness of correct practice was calculated as a total score.
McNamara's test was performed to test if there was a significant difference in knowledge
before the intervention and after the intervention in the intervention group, and at if there
was a significant difference in knowledge between baseline and follow-up in the control
group. In addition, independent t-test was used to compare the knowledge score differences
(knowledge score at follow up - knowledge score at baseline) between the intervention group
and the control group. Linear regression was conducted to evaluate the effect of the
educational intervention on the difference in knowledge score adjusting to variables that
were unbalanced at baseline.
Patients Adherence to the Recommendations was calculated as a total score for each
participant. Average score was evaluated across the intervention and control groups (using t
test).
Chi square test was used to compare HADS items at baseline between intervention and control
group. Besides, it was used to compare HADS items at follow-up between intervention and
control group. Independent t-test was used to compare the HADS score differences (between
baseline and at follow up) between the intervention group and the control group.
HADS scores were categorized into three categories based on the abnormality classification;
normal (less than eight), borderline abnormal (between eight and eleven) and abnormal (above
eleven). Chi square test was used to evaluate the association between HADS score categories
and intervention control status at baseline and at follow up.
The percentages (%) of patients' adherence to medication and non-pharmacological adherence
were calculated. The reasons behind the patient's non-adherence were themed into three
distinct groups (forgetfulness, run out, and unavailability of isotretinoin). The frequency
(%) of each group was calculated. Chi-square test was conducted to evaluate the association
between adherence status and patient intervention control status.
