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

Primary Purpose

Hypertension, Diabete Type 2, Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmaceutical intervention
Sponsored by
University of Sharjah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Hypertension, Diabete Type 2, Pharmacist interventions

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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

    This arm will receive standard care

    Outcomes

    Primary Outcome Measures

    Fasting plasma glucose
    The device used will be glucometer and the results will be expressed in (mmol/L)
    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.
    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.
    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)
    Blood pressure values
    Sphygmomanometer will be used to measure systolic and diastolic pressure values.
    Weight
    It will be reported in Kg
    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.

    Secondary Outcome Measures

    Knowledge about diabetes
    Diabetes Knowledge Questionnaire (DKQ) will be used
    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.
    Medication adherance
    he Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    August 1, 2022
    Sponsor
    University of Sharjah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05488002
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sharjah

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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; 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). patients with diabetes will be identified and Randomised using the same approach and followed up to 12 weeks (In order to monitor the HbA1c ). 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: To assess the impact of pharmacist counseling on the mortality rate of diabetic, hypertensive and obese patients. To study the impact of pharmacist counseling on the morbidity rate of diabetic, hypertensive and obese patients. To measure the effectiveness of pharmacist counseling on improving the blood pressure of hypertensive patients. To evaluate the benefits of pharmacist counseling on blood glucose level among diabetic patients. To examine the impact of pharmacist recommendations and medication review on the weight and cholesterol level among obese patients. To investigate potential adverse effects may be induced upon pharmacist counseling. To explore any drug-related problems may be induced by pharmacist interventions. To study the satisfaction of diabetic, hypertensive, and obese patients with pharmacist counselling.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Diabete Type 2, Obesity, Pharmacist-Patient Relations
    Keywords
    Hypertension, Diabete Type 2, Pharmacist interventions

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    720 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    This arm will receive standard care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pharmaceutical intervention
    Other Intervention Name(s)
    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 Description
    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.
    Primary Outcome Measure Information:
    Title
    Fasting plasma glucose
    Description
    The device used will be glucometer and the results will be expressed in (mmol/L)
    Time Frame
    Up to 3 months
    Title
    Glycosylated haemoglobin (HbA1c)
    Description
    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.
    Time Frame
    12 weeks
    Title
    Adherence to oral hypoglycaemic agents
    Description
    The Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.
    Time Frame
    Up to 3 months
    Title
    Drug-related problems
    Description
    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)
    Time Frame
    Up to 3 months
    Title
    Blood pressure values
    Description
    Sphygmomanometer will be used to measure systolic and diastolic pressure values.
    Time Frame
    Up to 3 months
    Title
    Weight
    Description
    It will be reported in Kg
    Time Frame
    6 months
    Title
    Cholesterol LDL-cholesterol Triglycerides Cholesterol LDL-cholesterol Triglycerides
    Description
    The cholesterol home test kit will be used and results will be expressed in milligrams (mg) of cholesterol per deciliter (dL) of blood.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Knowledge about diabetes
    Description
    Diabetes Knowledge Questionnaire (DKQ) will be used
    Time Frame
    Up to 3 months
    Title
    knowledge about hypertension
    Description
    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.
    Time Frame
    Up to 3 months
    Title
    Medication adherance
    Description
    he Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.
    Time Frame
    Up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion. Pregnancy. breastfeeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Osama Ibrahim, PhD
    Phone
    0097165057404
    Email
    oibrahim@sharjah.ac.ae
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Osama Ibrahim, PhD
    Organizational Affiliation
    Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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