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.
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.
- Conditions
- Diabetes, Hypertension, Dyslipidemias, Cardiac Disease, Asthma
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted18 Sep 2020
- Study start10 May 2015
- Primary completion10 Dec 2015
- Study completion30 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Prof. Iman Basheti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Iman Basheti, Applied Science Private University
- Investigators
- I A Basheti, Study director, Applied Science University, Amman, Jordan
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Syrian Refugees' Knowledge of Medications and Adherence Following a Randomized Control Trial Assessing the Effect of a Medication Management Review Service
- ClinicalTrials.gov ID
- NCT04554810
- Acronym / sponsor ID
- MOH-REC-160079
- Conditions
- Diabetes, Hypertension, Dyslipidemias, Cardiac Disease, Asthma
- Keywords
- Refugees, Medication management review, Adherence, Pharmaceutical care, chronic medication, Jordan, Universal health coverage, Sustainable development goal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Prof. Iman BashetiUniversity, hospital or other
- Study start
- 10 May 2015 (actual)
- Primary completion
- 10 Dec 2015 (actual)
- Study completion
- 30 Jan 2016 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Medication Management ServiceIntervention 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Management ServiceMedication 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. | Other | Intervention group |
Primary outcome
Adherence to medications scores
Time frame: 3 months
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.
Knowledge about chronic medications scores
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Derived from this study: PubMed 36240214Alalawneh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I A Basheti study director
Applied Science University, Amman, Jordan
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.