Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan
NCT ID: NCT06578689
Last Updated: 2024-08-29
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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RECRUITING
200 participants
OBSERVATIONAL
2024-01-01
2025-12-31
Brief Summary
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Methods: The study consisted of two phases. Phase one was a prospective cross-sectional study of 200 DM patients, including 94 with a history of DFU, where demographic and clinical data were collected to assess diabetic foot-associated risk factors and complications. Phase two was a randomized clinical trial with 105 DM patients: 52 in the control group received standard care, while 53 in the intervention group received standard care supplemented with formal educational session and ongoing foot care education via mobile health by a clinical pharmacist. Foot care practices and medication adherence were evaluated at baseline and after 8 weeks of follow-up.
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Detailed Description
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Aims: To assess DFU-related risk factors and complications among DM patients in Northern Jordan. Also, analyze the impact of educational intervention on their behavior.
Methods: A prospective cross-sectional sample of 200 DM patients, including 94 with a history of DFU was initially selected. Subsequently, a smaller cohort of 105 patients was randomized into either a control group or an intervention group after providing written informed consent. The control group received standard care, while the intervention group received standard care supplemented with formal educational session followed by ongoing education on foot care using mobile health by a clinical pharmacist. Diabetic foot-associated risk factors and complications were assessed. Foot care practices and medication adherence were evaluated for both the control and intervention groups at baseline and again after 8 weeks of follow-up. Binary logistic regression was employed to assess factors associated with DFU. The Chi-square test and independent sample t-test were used to compare the behavior between the two groups before and after the intervention.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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DM with DFU
Education
The control group received standard care, while the intervention group received standard care supplemented with formal educational session followed by ongoing education on foot care using mobile health by a clinical pharmacist.
DM without DFU
No interventions assigned to this group
Interventions
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Education
The control group received standard care, while the intervention group received standard care supplemented with formal educational session followed by ongoing education on foot care using mobile health by a clinical pharmacist.
Eligibility Criteria
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Inclusion Criteria
Have a mobile phone
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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King Abdullah University Hospital
OTHER
Responsible Party
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Samah Al-Shatnawi
Associate Professor
Locations
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Jordan University of Science and Technology
Irbid, , Jordan
Countries
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Facility Contacts
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Other Identifiers
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20240097
Identifier Type: -
Identifier Source: org_study_id
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