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

NCT06538168 | Not Yet Recruiting DMC

• 1 other identifier: UIPH
• Study Type: interventional
• Target: 2,430
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Past 3 months glycemic control

  12 months from baseline

• Hospitalization

  12 months from baseline

• Amputation status

  12 months from baseline

• Foot ulceration

  12 months from baseline

Study Arms (2)

intervention group

EXPERIMENTAL

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).

Behavioral: Diabetes Self-Management Education (DSME)

Control group

NO INTERVENTION

These participants do not receive any intervention.

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).

intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• University of Lahore: collaborator

Related Publications (3)

• Ackermann RT, O'Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Curr Diab Rep. 2020 Feb 20;20(3):9. doi: 10.1007/s11892-020-1293-4.

  PMID: 32080770 RESULT

• Arumalla N, Chan CKD, Gibson M, Man YL, Adas MA, Norton S, Galloway JB, Garrood T. The Clinical Impact of Electronic Patient-Reported Outcome Measures in the Remote Monitoring of Inflammatory Arthritis: A Systematic Review and Meta-analysis. Arthritis Rheumatol. 2023 Nov;75(11):1892-1903. doi: 10.1002/art.42559. Epub 2023 Sep 18.

  PMID: 37204273 RESULT

• Geidne S, Kokko S, Lane A, Ooms L, Vuillemin A, Seghers J, Koski P, Kudlacek M, Johnson S, Van Hoye A. Health Promotion Interventions in Sports Clubs: Can We Talk About a Setting-Based Approach? A Systematic Mapping Review. Health Educ Behav. 2019 Aug;46(4):592-601. doi: 10.1177/1090198119831749. Epub 2019 Feb 22.

  PMID: 30795690 RESULT

MeSH Terms

Conditions

Diabetic Foot

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

Central Study Contacts

Fahmina Jamil

CONTACT

03264316905; Fahminajamil220@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and/or assessors are unaware of who receives the intervention (treatment) or control. This reduces bias by ensuring that knowledge of the treatment does not influence outcomes assessment, thus enhancing the reliability of study results.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD studentship

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: July 30, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 25, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-07