Pharmacists Interventions on Patients Diabetic, and Obese Patients in the UAE: Randomized Controlled Trials.

Obesity Clinical Trial

Official title:

The Impact of Pharmacist Counseling and Follow-up on Hypertensive, Diabetic, and Obese Patients in the UAE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05488002
• Other study ID #: REC-22-03-17-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: University of Sharjah
• Contact: Osama Ibrahim, PhD
• Phone: 0097165057404
• Email: oibrahim[@]sharjah.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

1. 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).

2. patients with diabetes will be identified and Randomised using the same approach and followed up to 12 weeks (In order to monitor the HbA1c ).

3. 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:

1. To assess the impact of pharmacist counseling on the mortality rate of diabetic, hypertensive and obese patients.

2. To study the impact of pharmacist counseling on the morbidity rate of diabetic, hypertensive and obese patients.

3. To measure the effectiveness of pharmacist counseling on improving the blood pressure of hypertensive patients.

4. To evaluate the benefits of pharmacist counseling on blood glucose level among diabetic patients.

5. To examine the impact of pharmacist recommendations and medication review on the weight and cholesterol level among obese patients.

6. To investigate potential adverse effects may be induced upon pharmacist counseling.

7. To explore any drug-related problems may be induced by pharmacist interventions.

8. To study the satisfaction of diabetic, hypertensive, and obese patients with pharmacist counselling.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 720
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

3. BMI >30 , seeking to lose weight or improve eating habits will be recruited.

Exclusion Criteria:

1. Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion.

2. Pregnancy.

3. breastfeeding.

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Hypertension
• Obesity
• Pharmacist-Patient Relations

Intervention

Behavioral:
• Pharmaceutical intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sharjah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma glucose	The device used will be glucometer and the results will be expressed in (mmol/L)	Up to 3 months
Primary	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.	12 weeks
Primary	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.	Up to 3 months
Primary	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)	Up to 3 months
Primary	Blood pressure values	Sphygmomanometer will be used to measure systolic and diastolic pressure values.	Up to 3 months
Primary	Weight	It will be reported in Kg	6 months
Primary	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.	6 months
Secondary	Knowledge about diabetes	Diabetes Knowledge Questionnaire (DKQ) will be used	Up to 3 months
Secondary	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.	Up to 3 months
Secondary	Medication adherance	he Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.	Up to 3 months