Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05488002
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2022-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacists Interventions on Patients Diabetic, and Obese Patients in the UAE: Randomized Controlled Trials.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012449', 'term': 'Safety'}], 'ancestors': [{'id': 'D000056', 'term': 'Accident Prevention'}, {'id': 'D000059', 'term': 'Accidents'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).\n\nThese patients will be randomized into two groups : intervention, which will receive pharmaceutical intervention and control group, which will receive standard care\n\n\\*The general practitioner of each participant will be informed about the study by a letter.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting plasma glucose', 'timeFrame': 'Up to 3 months', 'description': 'The device used will be glucometer and the results will be expressed in (mmol/L)'}, {'measure': 'Glycosylated haemoglobin (HbA1c)', 'timeFrame': '12 weeks', '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.\n\nLess 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."}, {'measure': 'Adherence to oral hypoglycaemic agents', 'timeFrame': 'Up to 3 months', 'description': 'The Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.'}, {'measure': 'Drug-related problems', 'timeFrame': 'Up to 3 months', '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\n\n) which includes six main categories for treatment-related problems (Indication, Effectiveness, Safety, Knowledge, Adherence and Miscellaneous)'}, {'measure': 'Blood pressure values', 'timeFrame': 'Up to 3 months', 'description': 'Sphygmomanometer will be used to measure systolic and diastolic pressure values.'}, {'measure': 'Weight', 'timeFrame': '6 months', 'description': 'It will be reported in Kg'}, {'measure': 'Cholesterol LDL-cholesterol Triglycerides Cholesterol LDL-cholesterol Triglycerides', 'timeFrame': '6 months', 'description': 'The cholesterol home test kit will be used and results will be expressed in milligrams (mg) of cholesterol per deciliter (dL) of blood.'}], 'secondaryOutcomes': [{'measure': 'Knowledge about diabetes', 'timeFrame': 'Up to 3 months', 'description': 'Diabetes Knowledge Questionnaire (DKQ) will be used'}, {'measure': 'knowledge about hypertension', 'timeFrame': 'Up to 3 months', '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.'}, {'measure': 'Medication adherance', 'timeFrame': 'Up to 3 months', 'description': 'he Medication Adherence Reasons Scale (MAR-Scale) is a 20-item comprehensive scale that was developed to measure medication adherence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabete Type 2', 'Pharmacist interventions'], 'conditions': ['Hypertension', 'Diabete Type 2', 'Obesity', 'Pharmacist-Patient Relations']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "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;\n\n1. 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).\n2. patients with diabetes will be identified and Randomised using the same approach and followed up to 12 weeks (In order to monitor the HbA1c ).\n3. 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.\n\nThis 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.\n\n* 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.\n* 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.\n\nTherefore, the study aims to:\n\n1. To assess the impact of pharmacist counseling on the mortality rate of diabetic, hypertensive and obese patients.\n2. To study the impact of pharmacist counseling on the morbidity rate of diabetic, hypertensive and obese patients.\n3. To measure the effectiveness of pharmacist counseling on improving the blood pressure of hypertensive patients.\n4. To evaluate the benefits of pharmacist counseling on blood glucose level among diabetic patients.\n5. To examine the impact of pharmacist recommendations and medication review on the weight and cholesterol level among obese patients.\n6. To investigate potential adverse effects may be induced upon pharmacist counseling.\n7. To explore any drug-related problems may be induced by pharmacist interventions.\n8. To study the satisfaction of diabetic, hypertensive, and obese patients with pharmacist counselling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. 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.\n3. BMI \\>30 , seeking to lose weight or improve eating habits will be recruited.\n\nExclusion Criteria:\n\n1. Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion.\n2. Pregnancy.\n3. breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05488002', 'briefTitle': 'Pharmacists Interventions on Patients Diabetic, and Obese Patients in the UAE: Randomized Controlled Trials.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sharjah'}, 'officialTitle': 'The Impact of Pharmacist Counseling and Follow-up on Hypertensive, Diabetic, and Obese Patients in the UAE', 'orgStudyIdInfo': {'id': 'REC-22-03-17-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This arm will receive pharmaceutical interventions.\n\nHypertensive patients will receive pharmacist recommendations on hypertension Diabetic patients will receive pharmacist recommendations on diabetes Obese patients will receive pharmacist recommendations on obesity', 'interventionNames': ['Behavioral: Pharmaceutical intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This arm will receive standard care'}], 'interventions': [{'name': 'Pharmaceutical intervention', 'type': 'BEHAVIORAL', 'otherNames': ['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'], '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.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Osama Ibrahim, PhD', 'role': 'CONTACT', 'email': 'oibrahim@sharjah.ac.ae', 'phone': '0097165057404'}], 'overallOfficials': [{'name': 'Osama Ibrahim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor College of Pharmacy Pharmacy Practice & Pharmacotherapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sharjah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Osama Mohamed Ibrahim', 'investigatorAffiliation': 'University of Sharjah'}}}}