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临床试验/CTRI/2025/02/080235
CTRI/2025/02/080235尚未招募不适用

Development of a Public Health Pharmacy Model for Medication Therapy Management for Type 2 Diabetes Mellitus in Outpatient Settings at Udupi District

未提供1 个研究点 分布在 1 个国家目标入组 569 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
569
试验地点
1
主要终点
Development of a new Public Health Pharmacy model for MTM services on outpatient

研究概览

简要总结

This is an operational research study with multiple study designs following a sequential approach that will be enforced in phases (Phase I to IV).

In Phase 1, a situation analysis will be conducted at General Practitioner clinics and retail pharmacies to assess the current state of management for diabetes mellitus in outpatient settings using standardized patient (SP) methodology and a point prevalence survey. The patients will be recruited from multiple sites (144 pharmacies and 105 clinics) for 1 year till the calculated sample size is achieved.

In Phase 2, a Public Health Pharmacy (PHP) model will be developed, and experts will design a comprehensive PHP course focused on medication therapy management (MTM) for type II diabetes mellitus.

In Phase 3, the PHP model will be implemented by providing educational interventions to General practitioners and pharmacists in MTM and patients to enhance self-management skills. Interventions include various communication channels and novel educational strategies such as continuous education programs, providing drug information materials, and community outreach programs.

In Phase 4, The implemented PHP model-based interventions will be evaluated 1-2 months post-intervention by reassessing the Phase I study. Point prevalence surveys and SP methods will be used to measure improvements. Direct observations and interviews will be conducted with healthcare providers and patients to evaluate the effectiveness of MTM interventions and identify areas for further refinement.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • For Phase I, III, and IV: General Practitioners (GPs), community pharmacists, and outpatients with diabetes mellitus visiting community pharmacies and GP clinics For Phase II: 5th year Pharm D and 1st year M pharm in pharmacy practice.

排除标准

  • For Phase I, III, and IV:: General Practitioners (GPs), community pharmacists, and outpatients with diabetes mellitus visiting community pharmacies and GP clinics For Phase II: Students not willing to participate.

结局指标

主要结局

Development of a new Public Health Pharmacy model for MTM services on outpatient

时间窗: Baseline, 2 years.

次要结局

  • Capacity building among pharmacy students, community pharmacists, & general practitioners.(Baseline, 2 years)
  • Improved self-management skills among diabetes mellitus patients.(Baseline, 2 years)

研究者

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

Zuha Shyma

Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, MAHE, Manipal

研究点 (1)

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