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临床试验/NCT06658691
NCT06658691已完成不适用

Multidisciplinary Approach in Tertiary Teaching Settings to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes

University of Jordan1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2022年7月17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
119
试验地点
1
主要终点
Meeting the glycemic control goals

研究概览

简要总结

The study intervention was applying multidisciplinary approach consisting of an endocrinologist, a diabetes specialized nurse, and a clinical pharmacist to assess and improve diabetic foot care using a systematic screening, patients' risk categorization, therapy optimization, and tailored education.

详细描述

This is a single-blinded Randomized Controlled trial (RCT) study involving diabetic patients with (T1DM) and (T2DM) attending endocrine/diabetes, as well as, diabetic foot specialized surgery clinics for routine follow-ups at Jordan University Hospital (JUH) between 17 July 2022 and 30 Dec 2022.

The study evaluated the impacts of multidisciplinary approach in improving diabetic foot care. The clinical pharmacist role was to assess disease control, and to identify patients' therapeutic and educational needs through well-structured three months follow-up interviews with patients and/or their family members.

Moreover, the study investigated the impacts of multidisciplinary approach on health-related Quality of Life (QoL) at baseline and at the end of the study. Economic outcomes were also investigated relating to hospitalizations, length of stay, and cost of treatments.

The control group received standard care by hospital staff.

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 (Care Provider)

入排标准

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

入选标准

  • Aged above 18 years old.
  • Diabatic patients with T1DM and T2DM attending endocrine/diabetic and/or diabetic foot specialized surgery clinics for routine follow-ups at Jordan University Hospital (JUH).
  • Diabetic patients with or without previous Diabetic Foot Ulcers (DFUs) and/or amputation.

排除标准

  • Patients who were attending the clinics at the time of recruitment with active diabetic foot lesions and/or ulcers.
  • Patients who were taking corticosteroid medications.
  • Patients who were admitted to the hospital (inpatient admissions).
  • Pregnant women attending gestational DM clinics.
  • Patients with cognitive impairments and/or incapable to provide consent.

结局指标

主要结局

Meeting the glycemic control goals

时间窗: Up to 3 months

In both study groups, the glycemic control outcomes were measured based on the percentage of patients meeting the HbA1c of less than 7%, and percentage of patients meeting Random Blood Sugar (RBS) of less than 180 mg/dl (ADA, 2018).

次要结局

未报告次要终点

研究者

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

Majed Shafaamri

Clinical Research Assistant

University of Jordan

研究点 (1)

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