HypertensionNCT05488002
Pharmacists Interventions on Patients Diabetic, and Obese Patients in the UAE: Randomized Controlled Trials.
A study testing Pharmaceutical intervention in people with Hypertension and Diabete Type 2, run by University of Sharjah.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabete Type 2, Obesity
- What is being tested?
- Pharmaceutical intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion.
- Pregnancy.
- breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Pharmacist Counseling and Follow-up on Hypertensive, Diabetic, and Obese Patients in the UAE
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.
Read the 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.
- Conditions
- Hypertension, Diabete Type 2, Obesity, Pharmacist-Patient Relations
- Being tested
- Pharmaceutical intervention
- Keywords
- Hypertension, Diabete Type 2, Pharmacist interventions
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical interventionBehavioural
Also called Pharmacist recommendations, Heart monitoring, Blood glucose level monitoring, Weight monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Pharmaceutical intervention |
| Control | No intervention | This arm will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose
The device used will be glucometer and the results will be expressed in (mmol/L)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Up to 3 months
Blood pressure values
Sphygmomanometer will be used to measure systolic and diastolic pressure values.
Measured: Up to 3 months
Weight
It will be reported in Kg
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Knowledge about diabetes
Diabetes Knowledge Questionnaire (DKQ) will be used
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Mohamed Ibrahim, University of Sharjah
- Investigators
- Osama Ibrahim, PhD, Principal investigator, Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488002
- Sponsor's protocol ID
- REC-22-03-17-03
- Status last verified
- Aug 2022
- First submitted
- 29 Jun 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pharmacist Counseling and Follow-up on Hypertensive, Diabetic, and Obese Patients in the UAE
- ClinicalTrials.gov ID
- NCT05488002
- Acronym / sponsor ID
- REC-22-03-17-03
- Conditions
- Hypertension, Diabete Type 2, Obesity, Pharmacist-Patient Relations
- Keywords
- Hypertension, Diabete Type 2, Pharmacist interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pharmaceutical interventionThis 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion.
- Pregnancy.
- breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical interventionAlso: Pharmacist recommendations, Heart monitoring, Blood glucose level monitoring, Weight monitoringPharmacists 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. | Behavioural | Intervention |
Primary outcome
Fasting plasma glucose
Time frame: Up to 3 months
The device used will be glucometer and the results will be expressed in (mmol/L)
Glycosylated haemoglobin (HbA1c)
Time frame: 12 weeks
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
Time frame: Up to 3 months
The Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.
Drug-related problems
Time frame: Up to 3 months
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
Time frame: Up to 3 months
Sphygmomanometer will be used to measure systolic and diastolic pressure values.
Weight
Time frame: 6 months
It will be reported in Kg
Cholesterol LDL-cholesterol Triglycerides Cholesterol LDL-cholesterol Triglycerides
Time frame: 6 months
The cholesterol home test kit will be used and results will be expressed in milligrams (mg) of cholesterol per deciliter (dL) of blood.
3 secondary outcomes
Knowledge about diabetes
Time frame: Up to 3 months
knowledge about hypertension
Time frame: Up to 3 months
Medication adherance
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Ibrahim, PhD principal investigator
Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical intervention in people with Hypertension and Diabete Type 2, run by University of Sharjah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Ibrahim, PhD (0097165057404, oibrahim@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (time frame: Up to 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.