Multidisciplinary Approach to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes.
NCT ID: NCT06658691
Last Updated: 2024-10-26
Study Results
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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COMPLETED
NA
119 participants
INTERVENTIONAL
2022-07-17
2022-12-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Control group
Patients did not receive multidisciplinary approach
No interventions assigned to this group
Intervention group
Patients received multidisciplinary approach
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Jordan University Hospital
OTHER
University of Jordan
OTHER
Responsible Party
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Majed Shafaamri
Clinical Research Assistant
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
Countries
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Other Identifiers
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14296
Identifier Type: -
Identifier Source: org_study_id
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