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Completed

NCT Number: NCT06658691

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

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.

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Key information

Conditions

Multidisciplinary Approach Cardiovascular Diseases Clinical Pharmacists Diabetes Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer (DFU) Diabetic Neuropathies Economic Outcomes Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Multidisciplinary Care Team Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jordan

Amman, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Meeting the glycemic control goals

    Time frame: 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).

Other outcomes

  1. Mean HbA1c

    Time frame: Up to 3 months

    In both study groups, the number of patients per each risk group was assessed. Across the study period, any disease progressions and/or improvements were also recorded, and mean HbA1c was measured.

  2. Changes in Diabetic Foot Ulcer (DFU) predictors

    Time frame: Up to 3 months

    In both study groups, the number of patients per each risk group was assessed. Across the study period, any disease progressions and/or improvements were also recorded, and changes in Diabetic Foot Ulcer (DFU) predictors were measured.

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

    Time frame: Up to 3 months

    Treatment related Problems (TRPs) were categorized into: unnecessary drug therapy, untreated conditions that require drug therapy, efficacy, safety, inappropriate knowledge, inappropriate adherence, and need for additional/more frequent drug monitoring.

    After identifying TRPs, the frequencies of TRPs were calculated within both study groups. The clinical pharmacist's recommendations were successfully delivered to the medical team, and all actions were documented.

    The rate at which the physician approved or rejected the recommendations was recorded, alongside the reason(s) was/were also examined.

  4. Prevention of Diabetic Foot Ulcer (DFU) and/or amputation

    Time frame: Up to 3 months

    Intervention group was provided with targeted educational sessions in systematic, thorough, and repeated ways via face-to-face interviews, brochures, and recorded videos describing Diabetic Foot Ulcer (DFU) etiology, and daily foot self-care measures for patients and/or their family members. Also, the clinical pharmacist solved Treatment Related Problems (TRPs).

    Number of patients who developed newly DFUs events during the study period was assessed in both study groups.

  5. Health-related Quality of Life (QoL) status

    Time frame: Up to 3 months

    The health-related Quality of Life (QoL) was assessed using EuroQol-5 Dimensions- 3 Levels (EQ-5D-3L) instrument, which included five aspects (Mobility, Self-care, Usual activities, Pain/ Discomfort, Anxiety/ Depression) at baseline, and at the end of the study for both study groups.

    The degree of severity of the EQ-5D-3L status was categorized based on Tongsiri and Cairns 2011 classification as mild, moderate, or severe.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Collaborators

  • Jordan University Hospital

Registry information

Official study title

Multidisciplinary Approach in Tertiary Teaching Settings to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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