Impact of Clinical Pharmacist Led Intervention on Management of Diabetic Hypertensive Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change in blood pressure
研究概览
简要总结
Diabetic-Hypertensives are at a higher risk of premature microvascular and macrovascular complications than diabetes alone. Proper lifestyle management, diet, disease monitoring, and medication adherence is essential in achieving desired therapeutic outcomes, preventing complications and improving those patients' Health-Related Quality of Life (HRQoL). Pharmacists are the most accessible healthcare professionals to the public and have a crucial role in optimizing treatment outcomes in patients with chronic diseases such as diabetes and hypertension. Experimental trials' demonstrating the potential roles of pharmaceutical services is scarce in the literature, particularly in developing countries of south Asia. Therefore, the investigators plan to conduct a prospective-interventional trial to determine the potential impacts of pharmacist-supervised educational intervention on the management of "Type II diabetic with comorbid hypertension" patients. Patient data will be collected using patient's clinical profile forms, General Medication adherence Scale (GMAS), Patients Satisfaction towards pharmaceutical services (PSPSQ), Health Related-KAP questionnaires. Data will be verified, stored, entered into databases, and analyzed according to the data management plan. The findings will be compared in terms of clinical and nonclinical outcome measures between the control and test groups to ascertain the conclusion.
详细描述
Diabetics are twice as likely as non-diabetics to develop hypertension. Hypertension is a strong predictor of adverse cerebulo-vascular and cardiovascular events in people with diabetes, which increases risk of Premature micro-vascular and macro-vascular problems in patients encompassing both diseases. Therefore, strict glycemic and blood pressure control is essential to subdue complication and prevent dreadful cardiovascular events such as stroke, Ischemia and myocardial infarction. Participants with both chronic diseases may have lower HRQoL due to increased susceptibility towards cardiovascular comorbidities. Adherence to medication is equally crucial for treatment success. Pharmacist in collaboration with other healthcare members, could play a vital role in the care of patients and optimizing treatment outcomes in patients with chronic diseases .
Chronic disease management is of particular interest to clinical pharmacist since most intervention requires long-term prescription medication use. The international pharmaceutical federation (FIP) and world health organization (WHO) have implored pharmacists to support people with chronic disease through their expanded role that includes "pharmaceutical care." In Nepal, Clinical Pharmacy practice is still in early infancy, though few studies have shown encouraging impacts of pharmaceutical care services. Similarly, there is a significant gap in the literature in this region addressing the impact of pharmacist-supervised educational intervention on both clinical and nonclinical outcomes measures, primarily focusing on co-morbid Diabetes- Hypertensive patients. Therefore, these studies are intended to recap and fill that gap area and add new and valuable insight to the available literature.
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
- 40 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 40 to 68 years.
- •Clinically diagnosed with type II diabetes mellitus with hypertension as co-morbidity.
- •Minimum one year of the medical history of diabetic and hypertension.
- •Minimum 6 months on antidiabetic as well as antihypertensive medication therapy.
- •Patients willing to participate in the study and those providing written informed consent for participation.
排除标准
- •Patients with Type I diabetes mellitus, Diabetic insipidus, Gestational diabetes or other forms of diabetes.
- •Presence of other chronic disease co-morbidity other than hypertension and diabetes complications.
- •Mentally incompetent patients, Pregnant, critically ill patients (requiring hospital admission).
- •Patients have tuberculosis, Corona virus, and other highly communicable diseases.
- •Those patients not willing to performing routine follow-up visit.
结局指标
主要结局
Change in blood pressure
时间窗: baseline, follow up at 3 months and 6 months respectively
Assessed with measurement of Systolic and diastolic blood pressure in mmHg using sphygmomanometer
Impact of Intervention in Patients Medication Adherence
时间窗: baseline, follow up at 3 months and 6 months respectively
It will be measured using translated and validated Nepalese version of the 11-item Novel general medication adherence Scale (GMAS) questionnaire divided into three categories based on a four-level Likert scale. GMAS tools provide a wide range of components, including disease and medication burden, patient behavior both intentional and unintentional, and cost-related burden associated with non-adherence. Higher Scores better the outcomes, measured within categories and overall adherence level.
Change in blood glycemic profile
时间窗: baseline, follow up at 3 months and 6 months respectively
Assessed with measurement of Fasting Blood Sugar (FBS) and Post Prandial Blood Sugar (PPBS) in mg/dl.
Compare patients perceived Satisfaction of pharmaceutical care services
时间窗: baseline, follow up at 3 months and 6 months respectively
This will be assessed by using Nepali version of Patients Perceived satisfaction of Pharmacist care (PSPSQ. 2 ) questionnaire. This tool comprises 20 items questionnaire divided into three dimensions based on a four-point Likert scale. Dimensions include quality of care, pharmacist-patient relationships, and overall satisfaction. Higher scores represent better outcomes, measured within domains and overall satisfaction levels.
change in glycosylated hemoglobin (HbA1C) level
时间窗: baseline, follow up at 3 months and 6 months respectively
assessed from patients glycosylated hemoglobin (HbA1C) level test, measured in percent (%)
Change in Health related Quality of Life
时间窗: baseline, follow up at 3 months and 6 months respectively
Translated Nepali version of Euro 5 D 5 L questionnaire measures will be used to measure patients' health-related quality of life (HRQoL). This questionnaire created by the European Quality of Life Group (EuroQol Group) measure HRQoL in five dimension Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five levels to describe the severity: no problem, slight problem, moderate problem, severe problem, and unable (very severe). The outcomes will be measured in the overall health utility index value. The index value ranges from -1 to 1 (0 indicates death, \<0 indicates worse than death, and 1 indicates full health)
次要结局
- Change in routine clinical laboratory parameters of patients Lipid Profile test.(baseline, follow up at 3 months and 6 months respectively)
- Change in Patients health related Knowledge, Attitude and Practice(baseline, follow up at 3 months and 6 months respectively)
研究者
Dr. Prasanna Dahal
PhD Research Scholar
Chettinad Academy of Research and Education (Deemed to be University)