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DiabetesNCT04554810

Pharmacists Improving Refugees' Adherence and Knowledge of Their Chronic Medications

A study testing Medication Management Service in people with Diabetes and Hypertension, run by Prof. Iman Basheti.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes, Hypertension, Dyslipidemias
What is being tested?
Medication Management Service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
No sites listed yet
Study dates
10 May 2015to 30 Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Improving Syrian Refugees' Knowledge of Medications and Adherence Following a Randomized Control Trial Assessing the Effect of a Medication Management Review Service

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.

Read the 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.

Being tested
Medication Management Service
Keywords
Refugees, Medication management review, Adherence, Pharmaceutical care, chronic medication, Jordan, Universal health coverage, Sustainable development goal
Medical subject headings
Diabetes Mellitus, Hypertension, Dyslipidemias, Heart Diseases, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication Management ServiceOther

    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.

Study groups in NCT04554810
Study groupRoleWhat they receive
Intervention groupActive comparatorIntervention 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.
Receives: Other: Medication Management Service
Control groupNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start10 May 2015
  3. Primary completion10 Dec 2015
  4. Study completion30 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04554810
Sponsor's protocol ID
MOH-REC-160079
Status last verified
Sep 2020
First submitted
8 Sep 2020
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36240214

Questions about this trial

What is this clinical trial studying?

A study testing Medication Management Service in people with Diabetes and Hypertension, run by Prof. Iman Basheti.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to medications scores (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04554810, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

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