Multidisciplinary ApproachNCT06658691
Multidisciplinary Approach to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes.
A study testing Multidisciplinary approach in people with Multidisciplinary Approach and Clinical Pharmacists, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multidisciplinary Approach, Clinical Pharmacists, Diabetic Foot Ulcer (DFU)
- What is being tested?
- Multidisciplinary approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteJordan
- Study dates
- 17 Jul 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Approach in Tertiary Teaching Settings 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.
Read the 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.
- Conditions
- Multidisciplinary Approach, Clinical Pharmacists, Diabetic Foot Ulcer (DFU), Multidisciplinary Care Team, Diabetes, Economic Outcomes
- Being tested
- Multidisciplinary approach
- Keywords
- Multidisciplinary approach, Clinical pharmacists, Jordan, Jordan University Hospital, Diabetic Foot Ulcer (DFU), Multidisciplinary team, Diabetes, Economic outcomes
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary approachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients did not receive multidisciplinary approach |
| Intervention group | Experimental | Patients received multidisciplinary approach Receives: Other: Multidisciplinary approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start17 Jul 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidisciplinary ApproachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University Hospital
- Responsible party
- Principal investigator, Majed Shafaamri, University of Jordan
- Investigators
- Eman A Hammad, Principal investigator, Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658691
- Sponsor's protocol ID
- 14296
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach in Tertiary Teaching Settings to Improve Diabetic Foot Care: an Investigation of Clinical and Economic Outcomes
- ClinicalTrials.gov ID
- NCT06658691
- Acronym / sponsor ID
- 14296
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Jordan University Hospital
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients did not receive multidisciplinary approach |
| Intervention group | Experimental | Other: Multidisciplinary approachPatients received multidisciplinary approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary approachThe 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. | Other | Intervention group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman A Hammad principal investigator
Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary approach in people with Multidisciplinary Approach and Clinical Pharmacists, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meeting the glycemic control goals (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.