Effectiveness of a Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes
NCT Number: NCT06538168
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer
Interventions: BEHAVIORAL: Diabetes Self-Management Education (DSME)
Sponsor: Universiti Putra Malaysia
Collaborators: University of Lahore
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2430
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-30
Completion Date: 2025-06-25

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.

Primary Outcome Measures: Knowledge of Diabetic foot, Knowledge of Diabetic foot using a scale will be measured Likert Scale questions where participants rate their agreement with statements about foot care practices (e.g., "I always wear well-fitting shoes," with options ranging from "Strongly Disagree" to "Strongly Agree").

The total score is then used to categorize the participant's knowledge level. This categorization can be study-specific, but some common examples include:

* Low knowledge: Scoring less than 60% of questions correctly suggests a need for significant education on diabetic foot care.
* Moderate knowledge: Scoring between 60% and 80% indicates some understanding but may benefit from further education.
* High knowledge: Scoring above 80% suggests a good understanding of diabetic foot care principles., 12 months from baseline|Health related quality of life, Health related quality of life measured by EQ- 5D-3L. o measure the health-related quality of life at baseline, three-month, and 12-month post-intervention, EuroQol 5-Dimension- 3-level will be used. The European quality of life scale (EQ-5D-3L) has five dimensions and three levels. Each of the five dimensions comprising the EQ-5D descriptive system is divided into three levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating some problems LEVEL 3: indicating extreme problems, 1 (perfect health), with higher scores indicating higher health utility.

2- On a 20 cm vertical visual analog scale, the EQ-VAS captures the patient's self-rated health, with two unique endpoints such as "Best imaginable health condition" for a score of 100 and "Worst imaginable health state" for a score of 0., 12 months from baseline|Adherence to anti-diabetic medication, The secondary outcome is the change in medication adherence to antihypertensive treatment. Using the "pills taken over a certain period, divided by pills prescribed for that specific period", the primary outcome will be measured.it will be self-reporting. A cut-off value of 80% has been established from previous literature. Non-adherents will make up less than 80% of the population, while adherents will make up more than 80%., 12 months from baseline
Secondary Outcome Measures: Past 3 months glycemic control, The out come will be measured by HbA1c, 12 months from baseline|Hospitalization, measured by tracking for hospital admission, 12 months from baseline|Amputation status, Amputation status measured by confirming hospital records, 12 months from baseline|Foot ulceration, Foot ulceration will be measured by Wagner Wound Classification System Wagner Grade 0: Skin is intact with no open lesion or a pre-ulcerative lesion - may have a deformity or cellulitis Wagner Grade 1: Partial- or full-thickness ulcer (superficial ulcer) Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis (OM) Wagner Grade 3: Deep abscess, OM, or joint sepsis Wagner Grade 4: Partial-foot gangrene Wagner Grade 5: Whole-foot gangrene, 12 months from baseline