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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.
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;
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.
Therefore, the study aims to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Control | No Intervention | This arm will receive standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaceutical intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | The device used will be glucometer and the results will be expressed in (mmol/L) | Up to 3 months |
| 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 |
| 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 |
| 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 |
| Blood pressure values | Sphygmomanometer will be used to measure systolic and diastolic pressure values. | Up to 3 months |
| Weight | It will be reported in Kg |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge about diabetes | Diabetes Knowledge Questionnaire (DKQ) will be used | Up to 3 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osama Ibrahim, PhD | Contact | 0097165057404 | oibrahim@sharjah.ac.ae |
| Name | Affiliation | Role |
|---|---|---|
| Osama Ibrahim, PhD | Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics | Principal Investigator |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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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.
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| 6 months |
| 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 |
| Up to 3 months |
| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |