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临床试验/NCT06578689
NCT06578689招募中不适用

Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan

King Abdullah University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Number of patients with diabetic foot ulcers

研究概览

简要总结

Purpose: To assess diabetic foot ulcers (DFU)-related risk factors and complications among diabetes mellitus (DM) patients in Northern Jordan. Also, to analyze the impact of educational intervention on their behavior.

Methods: The study consisted of two phases. Phase one was a prospective cross-sectional study of 200 DM patients, including 94 with a history of DFU, where demographic and clinical data were collected to assess diabetic foot-associated risk factors and complications. Phase two was a randomized clinical trial with 105 DM patients: 52 in the control group received standard care, while 53 in the intervention group received standard care supplemented with formal educational session and ongoing foot care education via mobile health by a clinical pharmacist. Foot care practices and medication adherence were evaluated at baseline and after 8 weeks of follow-up.

详细描述

Background: Diabetes mellitus (DM) is a common chronic metabolic condition with numerous consequences, including diabetic foot ulcers. diabetic foot ulcer (DFU) is the major cause of non-traumatic lower extremity amputations. DFU is linked to several risk factors, including a lack of information and inadequate foot care practices. In Jordan, statistics on diabetic foot are few, with no evidence of the impact of patient education on disease outcomes.

Aims: To assess DFU-related risk factors and complications among DM patients in Northern Jordan. Also, analyze the impact of educational intervention on their behavior.

Methods: A prospective cross-sectional sample of 200 DM patients, including 94 with a history of DFU was initially selected. Subsequently, a smaller cohort of 105 patients was randomized into either a control group or an intervention group after providing written informed consent. The control group received standard care, while the intervention group received standard care supplemented with formal educational session followed by ongoing education on foot care using mobile health by a clinical pharmacist. Diabetic foot-associated risk factors and complications were assessed. Foot care practices and medication adherence were evaluated for both the control and intervention groups at baseline and again after 8 weeks of follow-up. Binary logistic regression was employed to assess factors associated with DFU. The Chi-square test and independent sample t-test were used to compare the behavior between the two groups before and after the intervention.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults DM (1 year)
  • Have a mobile phone

排除标准

  • Cognitive impairment

结局指标

主要结局

Number of patients with diabetic foot ulcers

时间窗: 8 weeks

Patients diagnosed with DM and have been diagnosed with DFU

Number of diabetic patients without diabetic foot ulcers

时间窗: 8 weeks

Patients diagnosed with DM and have no reported DFU

Number of patients receiving diabetic foot care education

时间窗: 8 weeks

Patients diagnosed with DM and received diabetic foot care education

次要结局

  • Number of patients reporting Medication adherence(8 weeks)
  • Number of patients reporting good foot care practices(8 weeks)

研究者

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

Samah Al-Shatnawi

Associate Professor

King Abdullah University Hospital

研究点 (1)

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