Impact Of Clinical Pharmacist Developed Educational Tool And Counselling on ADR’s of SGLT2 Inhibitor Users at Tertiary Care Teaching Hospital: A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Awareness on safe use of SGLT2 inhibitors.
研究概览
简要总结
This is a randomized, double blind, parallel group study, where we will include people on SGLT2 inhibitor as monotherapy or in combination with other drugs and must be a patient of T2DM, cardiovascular disease and/or chronic kidney disease till stage 4. Awareness on safe use of SGLT2 inhibitors will be given to patients on SGLT2 inhibiting drugs through patient counselling about sick day rule, early detection of ADR, immediate measures to be taken if ADR occurs, providing patient information leaflet and patient educational card. As secondary outcome, patients adherence to sick day rule and hygiene practices will be improved and as a result incidence and severity of ADRs will be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged more than or equal to 18 years.
- •The literate patients diagnosed with any cardiovascular disease, T2DM and CKD.
- •All patients on SGLT2 inhibitors, either as monotherapy or in combination with other drugs.
- •Patients willing to provide written consent for participation in the study.
排除标准
- •The patient with known history of Genital infections and UTI before taking SGLT2i.
- •Patient with incomplete demographics and laboratory findings.
- •Patients with T1 DM, Immunocompromised like STDs, serious complications like Cancer, terminally ill, cognitive impaired patients.
- •Pregnant and lactating women.
结局指标
主要结局
Awareness on safe use of SGLT2 inhibitors.
时间窗: 1 year
次要结局
- Reduction in incidence & severity of ADRs (based on WHO & Hartwig Siegel scales).(every 30 days for 3 months)
- Improved patient adherence to sick day rules & hygiene practices.(every 30 days for 3 months)
- Validate use of pharmacist-developed educational tool (card) in chronic disease management.
研究者
Dr Anushree Deshpande
KLE College of Pharmacy, Belagavi