NCT04554810

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2016

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 8, 2020

Last Update Submit

September 17, 2020

Conditions

Keywords

RefugeesMedication management reviewAdherencePharmaceutical carechronic medicationJordanUniversal health coverageSustainable development goal

Outcome Measures

Primary Outcomes (2)

  • Adherence to medications scores

    how often the patient during the last month forgot to take his/her medication/s, skipped it, stopped it when feeling better, stopped it when feeling worse or stopped it when they experienced a side effect. The measurement scale used in this questionnaire was scored at 0 (never), 1 (rarely), 2 (sometimes), 3 (often) and 4 (always). Hence, adherence was analysed as a continuous scale out of 32. Higher scores indicted lower adherence by the patient.

    3 months

  • Knowledge about chronic medications scores

    The questionnaire consisted of five questions related to patients' medications including 1- scientific medication name, 2- generic medication name, 3- how, 4- when, and 5- why was the patient taking each medication. The knowledge about medications was analysed as a continuous scale out of five. Higher scores indicated less knowledge about one's medication therapy.

    3 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Intervention group participants are the refugees who received the medication management review service and pharmacist's counselling. They have been assessed at baseline and at follow-up after 3 months) home visits.

Other: Medication Management Service

Control group

NO INTERVENTION

Control group participants are the refugees who did not received the medication management review service and no pharmacist's counselling wsa provided to them during the study period. They have been assessed at baseline and at follow-up (after 3 months) home visits.

Interventions

Medication review was delivered to the Syrian refugees by accredited pharmacists at the baseline visit. This followed by identifying the treatment-related problems (TRP) by the clinical pharmacist, and correction of the approved TRPs by the corresponding physicians and finally convey these changes in medications to the patients. In addition, counselling and education were delivered to the refugees' patients in the base line visit.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes MellitusHypertensionDyslipidemiasHeart DiseasesAsthma

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • I A Basheti

    Applied Science University, Amman, Jordan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor in Clinical Pharmacy

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 18, 2020

Study Start

May 10, 2015

Primary Completion

December 10, 2015

Study Completion

January 30, 2016

Last Updated

September 18, 2020

Record last verified: 2020-09