Clinical trial NCT06770829: Implementation of a Preventive Diabetic Foot Care Program for Patients at Risk of Diabetic Foot
Official title: The Effect of a Preventive Diabetic Foot Care Program on Knowledge, Behavior, Self-Management, and Glycemic Control Levels in Patients at Risk of Diabetic Foot
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Type 2 Diabetes Mellitus With Complication
Keywords: Nursing
Type 2 Diabetes Mellitus
Diabetic Foot
Preventive Diabetic Foot Care
Randomized Controlled Trial
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The DiaFOOTCare Program evaluates its impact on knowledge, behavior, self-management, and glycemic control by randomizing 78 type 2 diabetes patients with diabetic foot risk into intervention (n = 39) and control (n = 39) groups using block randomization (1:1 ratio). The intervention group receives educational tools, including an e-booklet with voice-over modules, a foot care checklist, a training video, a 20-25-minute face-to-face session, and personalized goal-tracking cards to monitor progress over three months. SMS reminders are sent three times weekly, and materials are shared via WhatsApp or email for accessibility. The control group receives a Ministry of Health brochure on diabetic foot care, explained using a tablet, and the same goal-tracking card as the intervention group. Post-intervention assessments, including diabetic foot knowledge, behavior, self-management scales, glycemic control, and goal card reviews, will determine program effectiveness after three months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effect of a preventive diabetic foot care program on the knowledge, behavior, self-management, and glycemic control levels of type 2 diabetic patients at risk of diabetic foot. The development of a Preventive Diabetic Foot Care Program (DiaFOOTCare) for patients with type 2 diabetes at risk of diabetic foot is expected to make a significant contribution to preventing diabetic foot formation. The DiaFOOTCare program consists of two stages. In the first phase, a comprehensive, multi-component, and evidence-based preventive diabetic foot care program will be designed specifically for type 2 diabetic patients at risk of diabetic foot. The internal validity of the program will be tested through expert evaluations by specialists in diabetic foot care, assessments using readability formulas, and pre-application testing with patients identified as being at risk of diabetic foot. As part of the final implementation of the first phase, all interventions included in the DiaFOOTCare protocol will be administered to four patients with diabetic foot risk over a three-week period. Following this, the DiaFOOTCare protocol will be evaluated based on the feedback provided by these four pre-application participants. In the second phase, a randomized controlled trial (RCT) with a single-blinded and active control group design will be conducted at the Akdeniz University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A group of patients with type 2 diabetes and diabetic foot risk will be identified, and pre-tests will be administered. The patients will then be randomly assigned to the intervention group (n=39) and the control group (n=39). The effectiveness of the DiaFOOTCare program will be assessed through post-tests.

Detailed description: Diabetic foot, a complication of diabetes, is a significant cause of morbidity and mortality, as well as associated challenges such as high healthcare costs and reduced quality of life. Studies have shown that adherence to treatment among individuals at risk for diabetic foot is consistently low. However, patient education and proper guidance on care can significantly reduce the incidence of foot ulcers. This study aims to evaluate the effect of a preventive diabetic foot care program on the knowledge, behavior, self-management, and glycemic control levels of type 2 diabetic patients with diabetic foot risk. The development of the Preventive Diabetic Foot Care Program (DiaFOOTCare) for patients with type 2 diabetes at risk of diabetic foot is expected to play a pivotal role in preventing diabetic foot formation.

Study Design and Methods This study is structured in two phases. In the first phase, the DiaFOOTCare program will be developed, and in the second phase, its effectiveness will be tested through a randomized active-controlled trial.

First Phase: Development of the DiaFOOTCare Program

The DiaFOOTCare program includes various educational and behavioral interventions:

An e-booklet on type 2 diabetes management and preventive diabetic foot care will be prepared. The e-booklet's content will be recorded as voice-over modules, allowing patients to listen to the training at any time during the follow-up period.

A preventive diabetic foot care checklist will be developed to improve patients' knowledge and behaviors related to foot care, accompanied by a training video featuring a simulated patient.

A 20-25 minute face-to-face training session on preventive diabetic foot care will be provided.

A goal-tracking card will be created to enhance diabetes self-management. During the initial interview, three-month individual diabetes management goals will be collaboratively set with the patients and recorded on their tracking cards. Patients will be instructed on how to complete these cards and will be asked to maintain them throughout the three-month period.

To support patients in achieving their diabetes management goals, Short Message Service (SMS) reminder messages will be sent three times a week. The e-booklet, voice-over modules, and video will be shared via WhatsApp or email, ensuring patients can access these materials on their phones or computers.

Second Phase: Testing the DiaFOOTCare Program The second phase will use a randomized controlled trial (RCT) design with single-blinding and an active control group. This phase will be conducted with type 2 diabetic patients at risk for diabetic foot who are treated at the Akdeniz University Hospital Endocrinology and Metabolism Polyclinic and meet the inclusion criteria.

Participants will be stratified based on their diabetic foot risk (categories 2 and 3 of the International Working Group on the Diabetic Foot \[IWGDF\] Risk Classification System) and randomized into two groups using stratified block randomization.

The intervention group (n=39) will receive routine outpatient follow-up along with all components of the DiaFOOTCare program over a three-month period.

The active control group (n=39) will be provided with a brochure on preventive diabetic foot care (available from the Ministry of Health website), explained by the researcher, and shared via WhatsApp or email. The control group will also use the goal-tracking card developed within the DiaFOOTCare program.

Outcome Measures At the end of the three-month period, diabetic foot knowledge, behavior, and self-management scales will be administered to all participants as part of the post-test. Glycemic control will be assessed, and the goal-tracking cards completed by the patients will be evaluated.

Sample Size and Randomization The sample size was calculated using the G\*POWER software based on an 80% power and a 5% significance level. A total of 78 participants will be included in the study, with 39 patients in each group.

To minimize assignment bias, stratified block randomization will be conducted using an independent researcher not involved in the study. This researcher will use a computer-based randomization method to assign participants to groups and will place the group assignments in opaque envelopes for use during the study. By implementing this method, potential bias during the randomization process is effectively controlled.

Eligibility criteria: Inclusion Criteria

Participants must meet all of the following criteria to be included in the study:

* Patients with type 2 diabetes receiving follow-up and treatment at the Akdeniz University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic.
* Presence of one or more diabetic foot risk factors, categorized as category 2 or 3 according to the IWGDF (International Working Group on the Diabetic Foot) Risk Classification System.
* Diagnosed with type 2 diabetes for at least six months.
* Aged between 30 and 65 years.
* Literate.
* No physical or mental disabilities that would prevent answering the study questions.
* No communication barriers.
* Able to understand and verbalize their diagnosis.
* HbA1c ≥7.5%.
* Internet access at home and possession of a device such as a computer, tablet, or smartphone, with the ability to use these tools.
* Willing to provide informed consent to participate in the study.

Exclusion Criteria

Participants will be excluded if they meet any of the following conditions:

* Myocardial infarction, stroke, heart failure, or angina pectoris within the last year.
* Diagnosed with type 1 diabetes or gestational diabetes.
* Presence of an active diabetic foot ulcer.
* Diagnosed with dementia or cognitive deficits.
* Diagnosed with glaucoma, cataracts, or retinopathy.
* Diagnosed with a terminal illness.
* Inability to provide accurate information or participate in the study.

Criteria for Exclusion During Follow-Up

Participants will be excluded from the study during the follow-up period if they meet any of the following conditions:

* Voluntarily choose to withdraw from the study.
* Fail to complete at least two-thirds of the follow-up period for any reason.
* Undergo bariatric surgery during the study.
* Exhibit non-adherence to prescribed medications.
* Have a general health condition that, according to their own statement, is unsuitable for continuing the study.

Primary outcomes:
measure: Diabetes Foot Knowledge Scale
timeFrame: 12 weeks
measure: Diabetic Foot Behaviour Scale
timeFrame: 12 weeks
measure: Nottingham Functional Foot Care Diagnosis Form
timeFrame: 12 weeks
measure: Diabetic Foot Self-Management Scale
timeFrame: 12 weeks
measure: Diabetic Foot Development Monitoring Form
timeFrame: 12 weeks
measure: Glycaemic Control Form
timeFrame: 12 weeks
measure: Target Tracking Cards
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Akdeniz University
name: Sultan Akcimen Patat
role: STUDY_CHAIR
References: