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

NCT ID: NCT06658691

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-17

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control group

Patients did not receive multidisciplinary approach

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Patients received multidisciplinary approach

Group Type EXPERIMENTAL

Multidisciplinary approach

Intervention Type 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.

Interventions

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Multidisciplinary approach

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 Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jordan University Hospital

OTHER

Sponsor Role collaborator

University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Majed Shafaamri

Clinical Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman A Hammad

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of Jordan

Amman, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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14296

Identifier Type: -

Identifier Source: org_study_id

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