Clinical trial NCT06538168: Effectiveness of a Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes
Official title: The Effect of a Comprehensive Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: University of Lahore
First posted: 2024-08-05
Enrollment: 2430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In an interventional parallel study design, participants are assigned to either an intervention group and a control group. The intervention group receives the treatment or intervention being tested, while the control group does not receive the intervention and serves as a comparison. This allows researchers to assess the effectiveness of the intervention by comparing outcomes between the two groups under controlled conditions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Diabetes is a major global health issue affecting over half a billion people worldwide, leading to serious complications such as diabetic foot ulcers (DFUs). The increasing incidence of DFUs necessitates further research to manage and prevent these severe complications. Healthcare professionals (HCPs) play a crucial role in addressing the rising incidence of diabetes and DFUs through capacity building and periodic education. However, many HCPs are inadequately prepared to deliver comprehensive diabetes self-management education (DSME), which is essential for preventing and treating DFUs.

The World Health Organization (WHO) reports that approximately 422 million people with diabetes live in low- and middle-income countries, with diabetes directly causing about 1.5 million deaths annually. Over the past few decades, there has been a consistent rise in both the incidence and prevalence of diabetes. This condition significantly contributes to renal disease, heart attacks, strokes, blindness, and lower extremities amputation, often resulting from infected foot ulcers. About 15% to 25% of diabetic patients develop foot ulcers at some point. Foot problems like ulcers, infections, and amputations are among the most significant complications of diabetes, but these issues can often be avoided with consistent foot care.

The study aims to understand how health promotion models have informed foot care interventions for older adults with diabetes. A review of 2,078 articles identified 31 studies that met eligibility criteria, focusing on foot care interventions for older adults. Most of these studies involved people with diabetes and used health promotion models such as the Self-Efficacy Theory and the Health Belief Model. The interventions showed promising outcomes in improving foot care for older adults, highlighting the need for further research to determine the most effective models and implementation strategies.

Previous research has several limitations: exclusion of relevant studies on intervention implementation, lack of consensus on foot-related outcome measures, selection bias due to convenience sampling techniques, cross-sectional designs making causal inferences impossible, moderate risk of bias in some studies, restriction to studies conducted between 2004 and 2022, lack of randomized or controlled samples in some studies, and immediate assessment of attitudes and skills post-training influencing health promotion models.

This research addresses the lack of diabetes education and the limited adoption of behavioral changes among the population, which lead to challenges in diabetes care. Effective education for healthcare professionals, communities, and patients is essential to improve diabetes management and reduce the risk of complications such as DFUs. The objectives of the study are to understand the contexts where health promotion models have informed foot care interventions, identify the health promotion models used in these interventions, and document the effectiveness of theoretically informed health promotion interventions in improving foot care for older adults.

Health promotion models like the Self-Efficacy Theory and the Health Belief Model have shown promising outcomes in improving foot care behaviors and knowledge. The studies vary in intervention approaches, delivery methods, and outcome measurements, emphasizing the need for further research to determine the most effective models and implementation strategies. There is a strong correlation between high knowledge of foot care and good practice, with varying levels of knowledge and engagement in foot-care activities like washing, drying, applying moisturizer, and trimming nails.

The study will assess the impact of DSME on non-ulcer diabetic foot incidents through a structured research design and statistical analysis. A review of existing studies shows that appropriate foot care practices are essential for preventing complications like DFUs. Common self-care practices include washing feet with lukewarm water, drying thoroughly, using moisturizing cream, inspecting feet daily, nail care, and wearing suitable footwear. Outcome measures in these studies included foot health outcomes, knowledge of foot health, foot care behaviors, and self-efficacy. The need for standardized outcome measures and further research on the effectiveness and cost-benefit of foot care interventions for older adults is highlighted.

The study will use an experimental design with a nonequivalent control group. Consecutive sampling will divide 230 participants into intervention and control groups. The Diabetes Self-Care Activities Foot Care Questionnaire will be used as the research instrument. Statistical analyses will include the Wilcoxon Signed Ranks Test and Mann-Whitney Test to compare the mean incidence of non-ulcerated diabetic foot incidents before and after the intervention.

The research will adhere to ethical guidelines, ensuring participant confidentiality, voluntary participation, and informed consent. Participants will be assured of their right to withdraw from the study at any time without any penalties.

Overall, this research aims to enhance diabetes education and promote behavioral changes to improve diabetes care and reduce the incidence of DFUs. Continuous training and education for HCPs are crucial for improving their competence in managing DFUs and achieving better patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Presence of a diabetic foot wound corresponding to Warner 2 - 4 Continuous existence of the diabetic foot lesion for a minimum of 4 weeks \< Participant has given written informed consent

Exclusion Criteria:

* Age \<18 years Pregnancy Present or expected non-compliance with the requirements of the study estimated by investigator at the time point of inclusion indication for amputation above the ankle level of the same Necrotic tissue with eschar present that cannot be debrided untreated osteitis or osteomyelitis Unexplored fistula

  * Malignancy of the wound Exposed nerves, vessels, or anastomotic areas
  * Ambulant negative pressure wound therapy of patients with anticoagulation therapy or higher grade impaired clotting function and a heightened risk for bleeding with relevant circulatory effects
  * Allergy to any disposal component of each treatment arm Severe anemia which is not caused by an infection
  * Simultaneous participation in other interventional trials / previous participation in this trial
  * Use of negative pressure wound therapy within 6 weeks before randomization

Primary outcomes:
measure: Knowledge of Diabetic foot
timeFrame: 12 months from baseline
measure: Health related quality of life
timeFrame: 12 months from baseline
measure: Adherence to anti-diabetic medication
timeFrame: 12 months from baseline
Secondary outcomes:
measure: Past 3 months glycemic control
timeFrame: 12 months from baseline
measure: Hospitalization
timeFrame: 12 months from baseline
measure: Amputation status
timeFrame: 12 months from baseline
measure: Foot ulceration
timeFrame: 12 months from baseline
Other outcomes:
Locations:
Study officials:
References:
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