The Impact of Pharmacist Counseling and Follow-up on Hypertensive, Diabetic, and Obese Patients in the UAE
试验速览
- 阶段
- 不适用
- 入组人数
- 720
- 主要终点
- Fasting plasma glucose
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Younger than 45,, being solely on insulin treatment (no oral hypoglycemic treatment) will also be an exclusion criterion.
- •breastfeeding.
结局指标
主要结局
Fasting plasma glucose
时间窗: Up to 3 months
The device used will be glucometer and the results will be expressed in (mmol/L)
Blood pressure values
时间窗: Up to 3 months
Sphygmomanometer will be used to measure systolic and diastolic pressure values.
Weight
时间窗: 6 months
It will be reported in Kg
Glycosylated haemoglobin (HbA1c)
时间窗: 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
时间窗: 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
时间窗: 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)
Cholesterol LDL-cholesterol Triglycerides Cholesterol LDL-cholesterol Triglycerides
时间窗: 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.
次要结局
- Knowledge about diabetes(Up to 3 months)
- knowledge about hypertension(Up to 3 months)
- Medication adherance(Up to 3 months)
研究者
Osama Mohamed Ibrahim
Associate professor
University of Sharjah