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临床试验/CTRI/2024/10/075863
CTRI/2024/10/075863尚未招募不适用

Assessment of drug related problems in patients with hypertension and type 2 diabetes : A prospective study

未提供1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年11月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1
主要终点
The prescription pattern of antihypertensives and antidiabetics in the clinical settings will be understood.

研究概览

简要总结

Aims & objectives : To identify and categorize drug related problems in patients with hypertension and type 2 diabetes using Hepler Strand categorization and the Pharmaceutical Care Network Europe classification method (PCNE)

To understand the prescription pattern of hypertension and type 2 diabetes.

To identify the drug-related problems in patients with hypertension and type 2 diabetes.

To classify the drug-related problems using Hepler Strand categorization and the Pharmaceutical Care Network Europe classification method (PCNE)

This prospective study will be carried out in the General Medicine Department- unit 7 of a Tertiary care hospital. Data will be collected daily through interviews with HTN and T2DM patients. A structured data collection form will be used to obtain details from patient medical records such as demographics, prescription information, medical progress notes, laboratory results. Drug related problems (DRPs) assessment will be carried out. The detection of the DRPs will be carried out through an active search following three steps.

Prescription analysis: the indication and dosage will be evaluated for prescription errors (dose, frequency, and indication) and potential drug interactions

Active search in medical records: the medical records will be investigated for clinical and laboratory parameters related to ineffectiveness and unreliability of medications.

Classification of DRPs: The suspected identification of DRPs that occurred during the hospitalization will be classified according to the PCNE and Hepler strand classification

Outcome measures:

The prescription pattern of antihypertensives and antidiabetics in the clinical settings will be understood.

DRPs associated with antihypertensive and antidiabetic prescriptions in clinical settings will be identified.

DRPs based on PCNE classification and Hepler Strand classification will be classified.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Adult patient above 18 years of age of both genders who are diagnosed with T2DM or HTN and are prescribed with at least 1 anti-diabetic or 1 anti-hypertensive drug.

排除标准

  • Patients who are Pregnant or lactating Diagnosed with T1DM or gestational DM Diagnosed with malignancy or autoimmune disorders.

结局指标

主要结局

The prescription pattern of antihypertensives and antidiabetics in the clinical settings will be understood.

时间窗: 5 months

DRPs associated with antihypertensive and antidiabetic prescriptions in clinical settings will be identified.

时间窗: 5 months

DRPs based on PCNE classification and Hepler Strand classification will be classified

时间窗: 5 months

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Anju Mary Reji

Manipal College of Pharmaceutical Sciences

研究点 (1)

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