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

NCT ID: NCT05488002

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-12-31

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.

Conditions

Hypertension; Diabete Type 2; Obesity; Pharmacist-Patient Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Pharmaceutical intervention

Intervention Type: 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.

Control

This arm will receive standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sharjah

OTHER

Sponsor Role: lead

Responsible Party

Osama Mohamed Ibrahim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osama Ibrahim, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics

Central Contacts

Osama Ibrahim, PhD

Role: CONTACT

oibrahim@sharjah.ac.ae

0097165057404

Other Identifiers

REC-22-03-17-03

Identifier Type: -

Identifier Source: org_study_id