The Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients in a Primary Medical Center in Jordan
November 18, 2024 updated by: Jyana Alelaimat, University of Jordan
A Randomized Controlled Trial to Assess the Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients for Optimum Treatment Outcomes in a Primary Medical Center in Jordan
This study aimed to assess the impact of the clinical pharmacist on enhancing type 2 diabetic patients outcomes in a primary health care center.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
About 103 patients with type 2 diabetes were randomized to control or intervention group, the control group received a standard care, while the intervention group received the collaborative care between the clinical pharmacist and physicians.
Fasting blood glucose, HbA1c, Lipid profile, and blood pressure measured for both groups at baseline and after three months of follow-up.
Treatment related problems (TRPs), quality of life, adherence, and patients knowledge about their medications were assessed.
Cost avoidance and clinical significance of implemented clinical pharmacist interventions were assessed too.
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Amman, Jordan
- Abu-Nsair medical center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- type 2 diabetic patients who aged 18 years or more with a HbA1c reading 6.5 % or more at the time of diagnosis
Exclusion Criteria:
- pregnant patients
- breastfeeding patients
- patients with urgent or emergent cases
- patients with cognitive impairment
- if the patient is unable to provide informed written consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: the intervention group
this group received the collaborative care between the clinical pharmacist and physicians in a medical center
|
For those who allocated to the intervention group, the clinical pharmacist interviewed them at each monthly visit about 30 minutes before seeing physicians, the clinical pharmacist identified treatment related problems, provided medication counseling, answered questions asked by patients or physicians, encouraged compliance, offered instructions on self-monitoring of blood pressure and glucose levels, distributed educational materials about diabetes and emphasis was made on optimizing adherence to pharmacological and non- pharmacological therapy.
the pharmacist interventions on treatment related problems (TRPs) and proposed patient care plans were discussed with treatng physicians who decided to accept or reject them.
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No Intervention: the control group
this group received the standard care of physicians in a medical center without clinical pharmacist interventions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HbA1c
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: 3 months
|
3 months
|
|
|
Lipid profile
Time Frame: 3 months
|
LDL , HDL , TGS
|
3 months
|
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Fasting blood glucose
Time Frame: each month for 3 months
|
each month for 3 months
|
|
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Patients knowledge about their medications
Time Frame: 3 months
|
Validated questionnaire were used.
According to Abu Farha et.al, Patients' medication knowledge was assessed by their ability to answer correctly the questions related to their medication doses, indications and timing.
For each correct statement the patient gained 1 point with a total of 3 points for each medication.
Patients were considered to have suboptimal knowledge if they obtain an average medication score of 2 or less.
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3 months
|
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Cost avoidance of implemented clinical pharmacist interventions
Time Frame: 3 months
|
The cost avoidance of implemented interventions were evaluated relevant to "presumed cost avoidance". This implies an action that reduces or eliminates additional spending that would have happened if the intervention had not occurred. The reduction in costs was estimated using the cost avoidance values that were derived from Campbell. The resulting cost avoidance values for individual clinical pharmacy intervention types are listed below for individual clinical pharmacy intervention type.* Intervention type, Overall cost avoidance, $ Addition of a medication 62.81
|
3 months
|
|
Patients adherence to medications
Time Frame: 3 months
|
Patients' adherence to medications was assessed by Oriana Awwad et al.2022 validated Arabic version of the Morisky, Green, and Levine (MGL) adherence scale [16], This scale is "a 4-item instrument used to identify patients with chronic disease who are not taking their medications as prescribed".
The scale encloses four questions: 1) "Do you ever forget to take your medicine?"
2) "Are you careless at times about taking your medicine?" 3) "When you feel better do you sometimes stop taking your medicine?"
and 4) "Sometimes if you feel worse when you take the medicine, do you stop taking it?"
It has a scoring scheme of "Yes" = 1 and "No" = 0 for each item with a total score ranging from 0 to 4. The sum of "Yes" answers provides a composite measure of non-adherence.
Lower evaluations imply a higher level of adherence, and total patient scores can be classified into high adherence level (0 answered "yes"), moderate adherence level (1-2 answered "yes") and low level adherence (3-4 "yes").
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3 months
|
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Quality of life
Time Frame: 3 months
|
The change in the Quality of Life questionnaire (EQ-5D-5L) was assessed.
At baseline, all patients were asked to self-complete the Quality of Life (EQ-5D-5L) questionnaire.
This self-completed questionnaire consists of 5 domains" (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression)" in which each dimension is rated with 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems).
The answers on these domains are translated to give a consequent number; e.g 23445.
These numbers have a health utility index score which already had been studied and validated for different population in a number of countries.
A single index value for all health states with a range from 0 (where zero is a health state equivalent to death).
Another factor express QoL is EQ-vas which is a scale from 0 to 100 where the patients are asked to indicate their overall health on the day after completion of questionnair.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2022
Primary Completion (Actual)
April 24, 2023
Study Completion (Actual)
April 24, 2023
Study Registration Dates
First Submitted
September 1, 2023
First Submitted That Met QC Criteria
September 1, 2023
First Posted (Actual)
September 8, 2023
Study Record Updates
Last Update Posted (Estimated)
November 21, 2024
Last Update Submitted That Met QC Criteria
November 18, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Clinical pharmacist
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.