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临床试验/NCT03531944
NCT03531944已完成不适用

The Impact of Community Pharmacist-Involved Collaborative Care in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore (IMPACT-C)

National University of Singapore2 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2018年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
265
试验地点
2
主要终点
Change in HbA1c level

研究概览

简要总结

Background: In Singapore, the prevalence of diabetes mellitus was approximately 12.8% in 2014 and the prevalence was projected to rise to 22.7% in 2035. In view of the complexity of diabetes management, collaborative efforts by nurses and other allied health professionals such as dietitians and pharmacists have shown to play a significant role in improving clinical care of individuals with diabetes. Currently in Singapore, the effectiveness of the collaborative care model has only been evaluated prospectively in the primary and tertiary care settings involving clinical pharmacists. The impact of the unique, synergistic roles of community pharmacists with family physician on the clinical, humanistic and economic outcomes have yet to be elucidated.

Aims: This study aims to evaluate the clinical, humanistic, and economic outcomes of a community pharmacist-involved collaborative care model in the management of individuals with type 2 diabetes mellitus.

Hypothesis: Incorporating community pharmacist into the care model with family physician and nurse can improve the clinical, humanistic, and economic outcomes of individuals with type 2 diabetes mellitus.

Methods: This study is a prospective, open label, parallel arm, randomized controlled trial. The study will be conducted over 6 months at a family medicine clinic in Singapore. Individuals aged 21 years and above, diagnosed with type 2 diabetes (HbA1c > 7.0%) and taking 5 or more chronic medications will be eligible. Individuals with Type 1 diabetes or who are unable to communicate independently in English, Mandarin or Malay will be excluded from this study. The participants will be randomly assigned to 2 groups using a random number generator or an equivalent: (1) Usual diabetes care with physician (control), (2) diabetes care with physician and community pharmacist (intervention). The community pharmacist will adopt the core elements of the medication therapy management model in reviewing the medications of participants as well as provide relevant lifestyle counselling and health education via a face-to-face consultation at the clinic and subsequently through telephonic correspondences. The primary outcome will be change in HbA1c over 6 months. Secondary outcomes include blood pressure, lipid markers, distress level, self-care capabilities, quality of life, productivity, and direct medical costs.

Significance: The outcomes of the community pharmacist-involved collaborative care model will support future implementation and integration of this care model into the standard of care in Singapore so as to optimize the management of type 2 diabetes.

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
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All individuals aged 21 years and above, diagnosed with type 2 diabetes mellitus with a baseline HbA1c of more than 7.0% and taking 5 or more chronic medications

排除标准

  • Individuals with type 1 diabetes mellitus
  • Mentally incapacitated individuals
  • Individuals who are illiterate and unable to communicate in English, Malay, or Chinese (Mandarin)
  • Individuals who are not able to complete the questionnaires

结局指标

主要结局

Change in HbA1c level

时间窗: Baseline and 6 months

Change in HbA1c level over 6 months

次要结局

  • Change in blood pressure(Baseline and 6 months)
  • Change in lipid markers(Baseline and 6 months)
  • Change in diabetes-related distress(Baseline and 6 months)
  • Change in general health status(Baseline and 6 months)
  • Change in self efficacy and self-care capabilities(Baseline and 6 months)
  • Cost effectiveness analysis(6 months)
  • Change in diabetes-specific quality of life(Baseline and 6 months)
  • Change in general work productivity(Baseline and 6 months)
  • Incidence of hypoglycemia(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joyce Lee, PharmD

Associate Professor

National University of Singapore

研究点 (2)

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