Clinical trial NCT04554810: Pharmacists Improving Refugees' Adherence and Knowledge of Their Chronic Medications
Official title: Improving Syrian Refugees' Knowledge of Medications and Adherence Following a Randomized Control Trial Assessing the Effect of a Medication Management Review Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Dyslipidemias
Cardiac Disease
Asthma
Keywords: Refugees
Medication management review
Adherence
Pharmaceutical care
chronic medication
Jordan
Universal health coverage
Sustainable development goal
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a randomized, controlled, single-blinded clinical study which conducted over six months (May to October 2016) in different Jordanian cities, where most of Syrian refugees reside. The primary aim of this study was to assess refugees' adherence and knowledge of their chronic medications, and impact of the medication management review (MMR) service delivered by a clinical pharmacist on their adherence and knowledge of their chronic medications three months following delivering the service.

An informed consent form was signed by all participants who accepted to participate (n=106). Participants were then randomized into intervention and control groups. The first group would have received the medication management review service during the study period, while the to the other group directly after the study was completed (after three months' time). Two validated questionnaire were used in the study for assessment; adherence to medications questionnaire and Knowledge about chronic medications questionnaire. These questionnaire were filled by tha patients at baseline and follow up home visits.

Detailed description: This study was a randomized interventional clinical study, conducted over six months (May to October 2016) in different Jordanian cities, where most of Syrian refugees reside. Clinics which are specialized for Syrian refugees were approached by the clinical pharmacist (researcher) in order to meet Syrian refugees, recruit eligible participants and arrange for their first home visits. An informed consent form was signed by all participants who accepted to participate. Participants were then randomized into intervention and control groups using a predetermined list obtained by the computer randomization program (www.randomizer.org). The study was single - blinded, hence, participants were not informed of the group they were randomized into, but they were informed that they would have been in either of two study groups. The first group would have received the medication management review (MMR) service during the study period, while the to the other group directly after the study was completed (after three months' time). Appointments were arranged at the physicians' clinics for all participants to be visited by the clinical pharmacist at their homes. At the baseline home visit, the clinical pharmacist documented participants' demographics, acute and chronic medical problems, history of present diseases, past medical history, lifestyle, family history, allergies, vital signs, physical examination information, diagnostic test data, lab results, current medications and issues related to the short and long term management of the patient .

The MMR service was completed following verification of collected baseline data. The home visits were planned not to exceed one hour. During these visits, self-completed questionnaires were completed by the participants, evaluating their adherence and knowledge about their chronic medications. The clinical pharmacist identified and documented the treatment-related problems (TRPs) for each patient in both groups at baseline. The physician was identified based on the participant's reported clinic and on participant's choice when more than one physician was visited by the participant. Following receipt of the letter, physicians addressed the recommendations and returned the letter to the pharmacist showing approved and rejected recommendations. Participants were called by the pharmacist to visit the physician and have the approved recommendations applied. Counselling and education were delivered to participants in the intervention group regarding their illnesses, knowledge of medications and adherence to their treatment. Three months post baseline, new appointments were arranged through a phone call by the clinical pharmacist, and all participants were revisited at home. Data needed to assess TRPs where recollected (as was done at baseline), plus the adherence and knowledge about chronic medications' questionnaires was completed for all participants. At the end of the study, control group participants received the MMR and pharmacist counselling service exactly as was delivered to the intervention group participants at baseline. For the purpose of data documentation and evaluation, the adherence to medication questionnaire and the knowledge about chronic medications were used. Data were coded then entered into the Statistical Package for Social Sciences (SPSS), version 20. Continuous variables were expressed as mean ± standard deviation . Differences within the same group were detected using paired sample t-test for continuous variables. Group differences (between the intervention and control groups) were detected using the independent sample t-test or Mann Whitney U-test (based on the normality of data following testing) for continuous variables. Categorical data were expressed as proportion (%) and analysed using Chi-square test. A probability value of \< 0.05 was considered to be statistically significant for all analysis's tests.

Eligibility criteria: Inclusion Criteria:

* being Syrian refugee ≥ 18 years, living in Jordan for more than six months prior to study recruitment and intending to stay for the whole study period
* having one chronic condition at least or taking 5 or more medications or taking more than 12 doses of a medication per day

Exclusion Criteria:

* Patients with cognitive or sensory impairment that may prevent conducting the interview.
* Patients who are planning to travel within the next six months after the baseline home-visit
* Patients who are not capable of reading or writing

Primary outcomes:
measure: Adherence to medications scores
timeFrame: 3 months
measure: Knowledge about chronic medications scores
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Applied Science University, Amman, Jordan
name: I A Basheti
role: STUDY_DIRECTOR
References:
citation: Alalawneh M, Berardi A, Nuaimi N, Basheti IA. Improving Syrian refugees' knowledge of medications and adherence following a randomized control trial assessing the effect of a medication management review service. PLoS One. 2022 Oct 14;17(10):e0276304. doi: 10.1371/journal.pone.0276304. eCollection 2022.