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

NCT06658691 | Completed DMC

• 1 other identifier: 14296
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Multidisciplinary approach; Clinical pharmacists; Jordan; Jordan University Hospital; Diabetic Foot Ulcer (DFU); Multidisciplinary team; Diabetes; Economic outcomes

Outcome Measures

Primary Outcomes (1)

• Meeting the glycemic control goals

  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).

  Up to 3 months

Other Outcomes (5)

• Mean HbA1c

  Up to 3 months

• Changes in Diabetic Foot Ulcer (DFU) predictors

  Up to 3 months

• Pharmacist interventions in identifying and resolving Treatment Related Problems (TRPs)

  Up to 3 months

Study Arms (2)

Control group

NO INTERVENTION

Patients did not receive multidisciplinary approach

Intervention group

EXPERIMENTAL

Patients received multidisciplinary approach

Other: Multidisciplinary approach

Interventions

Multidisciplinary approach OTHER

The study investigated a multidisciplinary approach consisting of an endocrinologist, a diabetes specialized nurse, and a clinical pharmacist to assess and improve diabetic foot care by systematic screening, patients' risk categorization, therapy optimization, and tailored education. Risk of Diabetic Foot Ulcer (DFU) occurrence was assessed and evaluated by the endocrinologist, and the nurse based on the 2019 International Working Group on Diabetes Mellitus (IWGDF). At that point, only the clinical pharmacist knew about patients' allocations. According to risk stratification, the clinical pharmacist provided intervention patients with educational sessions and tailored materials during scheduled three months follow-up interviews at Jordan University Hospital (JUH) DFU-related clinics. Moreover, the study evaluated the impacts of the multidisciplinary approach on health-related Quality of Life (QoL) at baseline and at the end of the study. Economic impacts were also further analyzed.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead
• Jordan University Hospital: collaborator

Study Sites (1)

University of Jordan

Amman, Jordan

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eman A Hammad

  Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Assistant

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 26, 2024
• Study Start: July 17, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

JO (1)