Multidisciplinary Approach to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes.

Not Applicable

Completed

• Conditions: Economic Outcomes; Multidisciplinary Approach; Clinical Pharmacists; Diabetic Foot Ulcer (DFU); Multidisciplinary Care Team; Diabetes

• Registration Number: NCT06658691
• Lead Sponsor: University of Jordan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-07-17
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-19
• Study First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Meeting the glycemic control goals	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).

Trial Locations

Locations (1)

University of Jordan; 🇯🇴 Amman, Jordan