The Impact of the Self-efficacy Building Nursing Program on Foot Self-care Confidence and Perceived Risk of Diabetes-related Foot Complications Among Diabetic Elderly Patients: A Randomized Virtual Based Trial

NCT06973850 | Enrolling By Invitation

• 1 other identifier: Mans01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Background: Diabetes-related foot complications are a major cause of morbidity among elderly patients with diabetes, often exacerbated by inadequate self-care practices and low self-efficacy. Innovative, accessible interventions are urgently needed to empower patients in preventive foot care. Objective: This study aimed to evaluate the impact of a self-efficacy building nursing program, delivered virtually, on foot self-care confidence and perceived risk of foot complications among elderly diabetic patients. Methods: A randomized controlled trial will be conducted with 120 elderly diabetic patients recruited from at the diabetic outpatient clinics at Damanhour City of El-Behaira Governorate, Egypt. Participants will be randomly assigned to either an intervention group (60 participants) receiving the virtual self-efficacy building program or a control group ( 60 participants) receiving no interventions. Outcomes Evaluation: Outcomes will be measured at baseline (pretest), and immediately post-interventions (Posttest) using validated scales. Keywords Self-efficacy, Foot self-care, Diabetes-related foot complications, Elderly patients, Virtual nursing intervention, randomized controlled trial

Conditions

Diabetes; Diabetes Mellitus; Foot Care

Keywords

Foot self-care; Self-efficacy; Diabetes-related foot complications; Virtual nursing intervention

Outcome Measures

Primary Outcomes (1)

• Foot Care Scale for Older Diabetics

  The Foot Care Scale for Older Diabetics (FCSOD) is a validated tool designed to assess foot self-care behaviors, confidence in performing foot care, and perceived risk of diabetes-related foot complications among elderly diabetic patients. It covers key areas such as daily foot inspection, hygiene, nail and skin care, footwear practices, and professional care seeking. Items are typically rated on a Likert scale, with higher scores indicating better self-care practices and greater confidence. The FCSOD has demonstrated strong reliability and validity, making it a valuable instrument for both clinical assessments and research studies aimed at improving foot health outcomes in older adults. Its user-friendly format also makes it suitable for elderly populations, whether self-administered or conducted via interviews.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Foot Care Confidence Scale (FCCS)

  through study completion, an average of 1 year

Study Arms (2)

Usual care

NO INTERVENTION

Control Group Participants in the control group will receive routine diabetes care as provided by the clinic, which may include brief verbal advice about foot care but no structured educational content or follow-up.

Intervention

EXPERIMENTAL

Intervention Description The Self-Efficacy Building Nursing Program is a structured, theory-based educational intervention grounded in Bandura's Self-Efficacy Theory. It aims to enhance participants' confidence in their ability to perform daily foot self-care behaviors and perceive their risk of complications accurately. The content includes: Educational modules on diabetes and foot health. Training on daily foot inspection, hygiene, nail and skin care, and appropriate footwear. Motivational strategies, goal setting, and problem-solving skills. Video demonstrations, live discussions, and Q\&A sessions with a diabetes nurse educator. The program will be delivered over four weekly virtual sessions, each lasting approximately 45-60 minutes, via a user-friendly telehealth platform (e.g., Zoom or WhatsApp Video). Follow-up support and reminders will be provided through weekly text messages and phone check-ins.

Behavioral: The Self-Efficacy Building Nursing Program

Interventions

The Self-Efficacy Building Nursing Program BEHAVIORAL

Intervention Description The Self-Efficacy Building Nursing Program is a structured, theory-based educational intervention grounded in Bandura's Self-Efficacy Theory. It aims to enhance participants' confidence in their ability to perform daily foot self-care behaviors and perceive their risk of complications accurately. The content includes: Educational modules on diabetes and foot health. Training on daily foot inspection, hygiene, nail and skin care, and appropriate footwear. Motivational strategies, goal setting, and problem-solving skills. Video demonstrations, live discussions, and Q\&A sessions with a diabetes nurse educator. The program will be delivered over four weekly virtual sessions, each lasting approximately 45-60 minutes, via a user-friendly telehealth platform (e.g., Zoom or WhatsApp Video). Follow-up support and reminders will be provided through weekly text messages and phone check-ins.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 60 years and above.
• Diagnosed with type 2 diabetes for at least one year.
• Able to use a smartphone or device with internet access.
• Willing to participate in a virtual education program.
• No current foot ulcers or advanced diabetic foot complications.

You may not qualify if:

• Cognitive impairment or psychiatric illness affecting comprehension.
• Severe visual or hearing impairments preventing participation.
• Participation in another educational or foot care intervention study within the past six months.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Mansoura, 1357, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatric and Mental Health Nursing, Faculty of Nursing-Mansoura University, Egypt

Model Details: This study utilizes a randomized controlled trial (RCT) design to investigate the effect of a self-efficacy building nursing program on foot self-care confidence and the perceived risk of diabetes-related foot complications among elderly diabetic patients. The intervention is delivered virtually, making the model particularly relevant in the context of limited mobility and accessibility constraints faced by elderly populations. Study Design and Setting The study will be conducted at diabetic outpatient clinics located in Damanhour City, El-Behaira Governorate, Egypt. A total of 120 elderly patients diagnosed with type 2 diabetes mellitus will be recruited through purposive sampling and randomly assigned to either the intervention or control group using a computer-generated randomization sequence to ensure allocation concealment. Each group will comprise 60 participants. Interventional Study Model This research adopts a parallel assignment model, with participants randomly assigned in

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: August 16, 2024
• Primary Completion: June 9, 2025
• Study Completion: August 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)