Clinical trial NCT06658691: Multidisciplinary Approach to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes.
Official title: Multidisciplinary Approach in Tertiary Teaching Settings to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Jordan University Hospital
First posted: 2024-10-26
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Meeting the glycemic control goals
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
measure: Mean HbA1c
timeFrame: Up to 3 months
measure: Changes in Diabetic Foot Ulcer (DFU) predictors
timeFrame: Up to 3 months
measure: Pharmacist interventions in identifying and resolving Treatment Related Problems (TRPs)
timeFrame: Up to 3 months
measure: Prevention of Diabetic Foot Ulcer (DFU) and/or amputation
timeFrame: Up to 3 months
measure: Health-related Quality of Life (QoL) status
timeFrame: Up to 3 months
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, University of Jordan
name: Eman A Hammad
role: PRINCIPAL_INVESTIGATOR
References: