Pharmacists Interventions on Patients Diabetic, and Obese Patients in the UAE: Randomized Controlled Trials.
Primary Purpose
Hypertension, Diabete Type 2, Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmaceutical intervention
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension focused on measuring Hypertension, Diabete Type 2, Pharmacist interventions
Eligibility Criteria
Inclusion Criteria:
- age between 45 years and 75 years, BMI: 25 kg ⁄ m2 , treatment with oral hypoglycemic medication for at least 12 months, and a regular visitor of the pharmacy.
- blood pressure (BP) measurements in the clinic of systolic BP (SBP) <140 mmHg and diastolic BP (DBP) <90 mmHg and they are on established antihypertensive drug treatment for at least 6 months.
- BMI >30 , seeking to lose weight or improve eating habits will be recruited.
Exclusion Criteria:
- Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion.
- Pregnancy.
- breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
This arm will receive pharmaceutical interventions. Hypertensive patients will receive pharmacist recommendations on hypertension Diabetic patients will receive pharmacist recommendations on diabetes Obese patients will receive pharmacist recommendations on obesity
This arm will receive standard care
Outcomes
Primary Outcome Measures
Fasting plasma glucose
The device used will be glucometer and the results will be expressed in (mmol/L)
Glycosylated haemoglobin (HbA1c)
An A1c test result gets reported as a percentage. The number represents the portion of hemoglobin proteins that are glycated, or holding glucose. The higher the percentage, the higher your blood sugar levels have been over the last few months.
Less than 5.7% means you don't have diabetes. 5.7% to 6.4% signals pre-diabetes. 6.5% or higher means a diabetes diagnosis. 7% or lower is the goal for someone trying to manage their diabetes.
Adherence to oral hypoglycaemic agents
The Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.
Drug-related problems
We will use a drug-related problems classification system developed by Prof. Salah (AbuRuz, S.M., Bulatova, N.R. & Yousef, A.M. Validation of a comprehensive classification tool for treatment-related problems . Pharm World Sci 28, 222-232 (2006). https://doi.org/10.1007/s11096-006-9048-0
) which includes six main categories for treatment-related problems (Indication, Effectiveness, Safety, Knowledge, Adherence and Miscellaneous)
Blood pressure values
Sphygmomanometer will be used to measure systolic and diastolic pressure values.
Weight
It will be reported in Kg
Cholesterol LDL-cholesterol Triglycerides Cholesterol LDL-cholesterol Triglycerides
The cholesterol home test kit will be used and results will be expressed in milligrams (mg) of cholesterol per deciliter (dL) of blood.
Secondary Outcome Measures
Knowledge about diabetes
Diabetes Knowledge Questionnaire (DKQ) will be used
knowledge about hypertension
The HKT is a simple questionnaire for assessing and monitoring HBP knowledge. It is sensitive to differences in blood pressure control status and should provide a valid, reliable, and standardized measure of HBP knowledge with wide relevance.
Medication adherance
he Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05488002
Brief Title
Pharmacists Interventions on Patients Diabetic, and Obese Patients in the UAE: Randomized Controlled Trials.
Official Title
The Impact of Pharmacist Counseling and Follow-up on Hypertensive, Diabetic, and Obese Patients in the UAE
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypertension, diabetes, and obesity are considered major risk factors for cardiovascular diseases and premature mortality worldwide. Furthermore, they have severe consequences on quality of life among patients. With increasing challenges facing the healthcare systems, pharmacists are well positioned to take on a greater role in the management of chronic diseases.
The present study aims to investigate the impact of pharmacist counselling on the clinical outcomes (weight, mortality, blood pressure, blood glucose) of hypertensive, diabetic, and obese patients.
Detailed Description
This will be a multicentric randomized, controlled trial comparing enhanced pharmacist care (which included independent patient assessment, counseling, and follow-up) with usual care in the UAE over a year. Generally, this research project will be conducted on 3 phases;
patients who suffer from elevated blood pressure will be Randomised into two groups, of which one of them will receive a standard care and the second one will receive pharmaceutical care. Both will be followed up to 26 weeks (an estimated period to monitor blood pressure change).
patients with diabetes will be identified and Randomised using the same approach and followed up to 12 weeks (In order to monitor the HbA1c ).
Patients with obesity (BMI is 30 or higher) will be Randomised and followed up to 16 weeks (according to the literature, this is the period required to monitor the BMI change). SPSS V26 will be used for Data analysis.
This research will enable the determination of the effectiveness of pharmacist counseling and follow-up in improving the clinical outcomes of chronic diseases (diabetes, hypertension, and obese) patients, which has never been assessed in the UAE.
The provided evidence may help in the implementation of a new novel practice in the world, in which the pharmacist's roles are expanded and evolved to include continual counseling on chronic disease patients and follow up. Thus, reducing the burden, and ensure sustainability of the healthcare services in the UAE.
Publications in peer-reviewed journals (At least 3 papers are expected), both international and local and conference presentations will be attempted to share the findings of our research.
Therefore, the study aims to:
To assess the impact of pharmacist counseling on the mortality rate of diabetic, hypertensive and obese patients.
To study the impact of pharmacist counseling on the morbidity rate of diabetic, hypertensive and obese patients.
To measure the effectiveness of pharmacist counseling on improving the blood pressure of hypertensive patients.
To evaluate the benefits of pharmacist counseling on blood glucose level among diabetic patients.
To examine the impact of pharmacist recommendations and medication review on the weight and cholesterol level among obese patients.
To investigate potential adverse effects may be induced upon pharmacist counseling.
To explore any drug-related problems may be induced by pharmacist interventions.
To study the satisfaction of diabetic, hypertensive, and obese patients with pharmacist counselling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabete Type 2, Obesity, Pharmacist-Patient Relations
Keywords
Hypertension, Diabete Type 2, Pharmacist interventions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study comprises 3 trials with the same intervention. Pharmacists will be trained how to recruit patients and perform pharmaceutical interventions. Each pharmacy will be required to recruit 45patients (15 hypertension, 15 diabetes, and 15 obese).
These patients will be randomized into two groups : intervention, which will receive pharmaceutical intervention and control group, which will receive standard care
*The general practitioner of each participant will be informed about the study by a letter.
Masking
Participant
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm will receive pharmaceutical interventions.
Hypertensive patients will receive pharmacist recommendations on hypertension Diabetic patients will receive pharmacist recommendations on diabetes Obese patients will receive pharmacist recommendations on obesity
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will receive standard care
Intervention Type
Behavioral
Intervention Name(s)
Pharmaceutical intervention
Other Intervention Name(s)
Pharmacist recommendations, Heart monitoring, Blood glucose level monitoring, Weight monitoring, Medication adherence follow-up, Coaching on medication use and safety, Coaching on healthy diet, Mental and emotional support
Intervention Description
Pharmacists will provide clinical recommendations to patients allocated to the intervention group. Furthermore, they will monitor patients' parameters and follow-up with them. These interventions include daily medication review, weight, heart monitoring, blood glucose level, follow-up on medication adherence, and even mental status.
Primary Outcome Measure Information:
Title
Fasting plasma glucose
Description
The device used will be glucometer and the results will be expressed in (mmol/L)
Time Frame
Up to 3 months
Title
Glycosylated haemoglobin (HbA1c)
Description
An A1c test result gets reported as a percentage. The number represents the portion of hemoglobin proteins that are glycated, or holding glucose. The higher the percentage, the higher your blood sugar levels have been over the last few months.
Less than 5.7% means you don't have diabetes. 5.7% to 6.4% signals pre-diabetes. 6.5% or higher means a diabetes diagnosis. 7% or lower is the goal for someone trying to manage their diabetes.
Time Frame
12 weeks
Title
Adherence to oral hypoglycaemic agents
Description
The Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.
Time Frame
Up to 3 months
Title
Drug-related problems
Description
We will use a drug-related problems classification system developed by Prof. Salah (AbuRuz, S.M., Bulatova, N.R. & Yousef, A.M. Validation of a comprehensive classification tool for treatment-related problems . Pharm World Sci 28, 222-232 (2006). https://doi.org/10.1007/s11096-006-9048-0
) which includes six main categories for treatment-related problems (Indication, Effectiveness, Safety, Knowledge, Adherence and Miscellaneous)
Time Frame
Up to 3 months
Title
Blood pressure values
Description
Sphygmomanometer will be used to measure systolic and diastolic pressure values.
Time Frame
Up to 3 months
Title
Weight
Description
It will be reported in Kg
Time Frame
6 months
Title
Cholesterol LDL-cholesterol Triglycerides Cholesterol LDL-cholesterol Triglycerides
Description
The cholesterol home test kit will be used and results will be expressed in milligrams (mg) of cholesterol per deciliter (dL) of blood.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knowledge about diabetes
Description
Diabetes Knowledge Questionnaire (DKQ) will be used
Time Frame
Up to 3 months
Title
knowledge about hypertension
Description
The HKT is a simple questionnaire for assessing and monitoring HBP knowledge. It is sensitive to differences in blood pressure control status and should provide a valid, reliable, and standardized measure of HBP knowledge with wide relevance.
Time Frame
Up to 3 months
Title
Medication adherance
Description
he Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age between 45 years and 75 years, BMI: 25 kg ⁄ m2 , treatment with oral hypoglycemic medication for at least 12 months, and a regular visitor of the pharmacy.
blood pressure (BP) measurements in the clinic of systolic BP (SBP) <140 mmHg and diastolic BP (DBP) <90 mmHg and they are on established antihypertensive drug treatment for at least 6 months.
BMI >30 , seeking to lose weight or improve eating habits will be recruited.
Exclusion Criteria:
Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion.
Pregnancy.
breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama Ibrahim, PhD
Phone
0097165057404
Email
oibrahim@sharjah.ac.ae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Ibrahim, PhD
Organizational Affiliation
Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacists Interventions on Patients Diabetic, and Obese Patients in the UAE: Randomized Controlled Trials.
We'll reach out to this number within 24 hrs