Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot

NCT07563751 | Not Yet Recruiting

• 1 other identifier: DF-EDU-RCT-2026
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of a structured educational program on pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life among adults with diabetic foot. Diabetic foot complications are a major cause of morbidity, reduced quality of life, and disability among patients with diabetes mellitus. Poor self-care practices and inadequate knowledge contribute significantly to the progression of foot ulcers and related complications. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured educational program designed to improve knowledge, self-management skills, and adherence to recommended diabetic foot care practices. The control group will receive routine care provided by the healthcare facility. The educational program focuses on key areas including foot hygiene, daily foot inspection, appropriate footwear, glycemic control, and early identification of warning signs of complications. The primary outcomes of the study include changes in pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life, which will be assessed at baseline and after the intervention period. The findings of this study are expected to contribute to improving nursing educational interventions and enhancing self-management outcomes among patients with diabetic foot.

Conditions

Diabetic Foot

Keywords

Pain Intensity; Self-Efficacy; Foot Self-Care Behaviors; Quality of Life; Diabetic foot

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measured Using the Numeric Rating Scale (NRS)

  Change in pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.

  Baseline and post-intervention (4-8 weeks).

Secondary Outcomes (1)

• Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES)

  Baseline and post-intervention (4-8 weeks).

Other Outcomes (2)

• Foot Self-Care Behaviors Measured Using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En)

  Baseline and post-intervention (4-8 weeks).

• Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire

  Baseline and post-intervention (4-8 weeks).

Study Arms (2)

Educational Program Group

EXPERIMENTAL

Behavioral: Structured Educational Program

Control Group

ACTIVE COMPARATOR

Behavioral: Structured Educational Program

Interventions

Structured Educational Program BEHAVIORAL

A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management. The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications. Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.

Control Group; Educational Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• Diagnosed with diabetic foot
• Able to communicate effectively
• Willing to participate in the educational program
• Able to provide written informed consent

You may not qualify if:

• Patients with severe or unstable medical conditions (e.g., advanced heart failure, renal failure, or active infections) that may interfere with participation
• Patients with major lower-limb amputation or severe foot deformities preventing participation in the educational program or assessments
• Patients with cognitive impairments, psychiatric disorders, or communication difficulties affecting understanding or compliance
• Pregnant or lactating women
• Patients who refuse to provide informed consent or withdraw at any stage of the study

Sponsors & Collaborators

• Jerash Private University: lead

Study Sites (1)

Ministry of Health Primary Healthcare Centers

Jerash, Dours, 009627, Jordan

Location

MeSH Terms

Conditions

Diabetic Foot; Pain

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jawad AHMAD Ahmed, Asst.Prof.Dr

  Jerash University, Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

CONTACT

+962779084560; JAWAD_0799@YAHOO.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied. Participants and investigators will be aware of group assignments due to the nature of the educational intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Nursing

Model Details: This is a randomized controlled trial with two parallel groups: an intervention group receiving a structured educational program and a control group receiving routine care. Participants will be assigned to groups using random allocation.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)