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

NCT05488002 | Unknown DMC

• 1 other identifier: REC-22-03-17-03
• Study Type: interventional
• Target: 720
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Hypertension; Diabete Type 2; Pharmacist interventions

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (3)

• Knowledge about diabetes

  Up to 3 months

• knowledge about hypertension

  Up to 3 months

• Medication adherance

  Up to 3 months

Study Arms (2)

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

Behavioral: Pharmaceutical intervention

Control

NO INTERVENTION

This arm will receive standard care

Interventions

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.

Also known as: 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy.
• breastfeeding.

Sponsors & Collaborators

• University of Sharjah: lead

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Obesity

Interventions

Safety

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Osama Ibrahim, PhD

  Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Ibrahim, PhD

CONTACT

0097165057404; oibrahim@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: August 4, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share