Effectiveness of a Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes

Sponsor
Universiti Putra Malaysia
Study ID
NCT06538168
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diabetes Self-Management Education (DSME) — BEHAVIORAL
    The intervention, Diabetes Self-Management Education (DSME), involves a structured educational program including daily reminders regarding medication, and foot care, educational-led video weekly, and handouts for the management od diabetes and foot care to enhance knowledge and skills in managing diabetes and preventing complications like diabetic foot ulcers (DFUs).

Study Details

Diabetes is a significant global health concern, affecting over half a billion people and leading to severe complications like diabetic foot ulcers (DFUs). The increasing incidence of DFUs highlights the need for ongoing research and effective prevention strategies. A major challenge in managing DFUs is the inadequate preparation of healthcare professionals (HCPs) in delivering comprehensive diabetes self-management education (DSME). Enhancing the education and training of HCPs is essential to improve diabetes management and reduce DFUs. Studies show that patients' knowledge and self-care practices vary widely, with common foot-care activities including washing, drying, applying moisturizer, and routine nail care. Improving these self-care practices is crucial for early recognition and management of DFUs to reduce the risk of amputations. Health promotion models such as the Self-Efficacy Theory and Health Belief Model have shown promise in informing foot care interventions, but further research is needed to determine the most effective strategies. Previous research has several limitations, including selection bias, lack of consensus on outcome measures, and moderate risk of bias in some studies. The proposed study will use an experimental design with a nonequivalent control group to assess the effectiveness of DSME in reducing non-ulcerated diabetic foot incidents. Data will be collected using the Diabetes Self-Care Activities Foot Care Questionnaire and analyzed with statistical tests. Ethical guidelines will be strictly followed, ensuring participant confidentiality and voluntary participation. Overall, this research aims to address gaps in diabetes education and promote behavioral changes to improve diabetes care and reduce DFUs. Continuous training and education for HCPs are vital for enhancing their competence in managing DFUs and improving patient outcomes.

Key Dates

First listed
Aug 5, 2024
Start date
Jul 30, 2024
Status verified
Jul 2024
Primary completion
May 15, 2025
Completion
Jun 25, 2025

Study Design

Enrollment
2,430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: intervention group
    The intervention group typically consists of participants who are subjected to the Diabetes Self-Management Education (DSME) program The intervention, Diabetes Self-Management Education (DSME), involves a structured educational program including daily reminders regarding medication, and foot care, educational-led video weekly, and handouts for the management of diabetes and foot care to enhance knowledge and skills in managing diabetes and preventing complications like diabetic foot ulcers (DFUs).
  • No Intervention: Control group
    These participants do not receive any intervention.

Primary Outcome Measure

Knowledge of Diabetic foot [ Time Frame: 12 months from baseline ]

Central Contacts

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