Clinical trial NCT05488002: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Diabete Type 2
Obesity
Pharmacist-Patient Relations
Keywords: Hypertension
Diabete Type 2
Pharmacist interventions
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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;

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting plasma glucose
timeFrame: Up to 3 months
measure: Glycosylated haemoglobin (HbA1c)
timeFrame: 12 weeks
measure: Adherence to oral hypoglycaemic agents
timeFrame: Up to 3 months
measure: Drug-related problems
timeFrame: Up to 3 months
measure: Blood pressure values
timeFrame: Up to 3 months
measure: Weight
timeFrame: 6 months
measure: Cholesterol LDL-cholesterol Triglycerides Cholesterol LDL-cholesterol Triglycerides
timeFrame: 6 months
Secondary outcomes:
measure: Knowledge about diabetes
timeFrame: Up to 3 months
measure: knowledge about hypertension
timeFrame: Up to 3 months
measure: Medication adherance
timeFrame: Up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics
name: Osama Ibrahim, PhD
role: PRINCIPAL_INVESTIGATOR
References: