Clinical trial NCT06780631: The Effect of Web-Based and Face-to-Face Education Based on the Health Promotion Model on Foot Care Behavior in Individuals With Type 2 Diabetes
Official title: The Effect of Web-Based and Face-to-Face Education Based on the Health Promotion Model on Foot Care Behavior in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Foot
Diabetes Mellitus Type 2
Keywords: Diabetic Foot
Self Care
Health Promotiom Model
Web Based Education
Face to Face Education
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a prospective intervention type three-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as web-based diabetic foot training, Group-2 (Experiment) was designed s face-to-face diabetic foot training, and Group-3 (Control) was designed as clinical routine training.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetic foot is a complication that develops difficult-to-heal foot wounds, reduces the quality of life of individuals with diabetes, causes loss of productivity, and causes economic burden due to the repetition of the problem and the expenditures made for treatment. Diabetic foot is the most common complication requiring hospitalization and is the most common cause of non-traumatic amputations. However, this complication can be prevented with regular foot examinations, patient education and daily foot care. For this reason, diabetic foot education should be given to all diabetic patients and they should be encouraged to participate in their self-care. However, educating patients once does not provide enough knowledge to manage diabetes throughout life. As the rate of individuals using web-based information increases, it is possible to reach large masses. With web-based training, information obtained from current sources is presented to patients on a single web page, patients can access training regardless of place or time, and continuity in training is ensured. The aim of this randomized controlled experimental study is to determine the effect of web-based and face-to-face education based on the health promotion model on diabetic foot knowledge and foot care behavior in individuals with diabetes.

Detailed description: The research will be conducted with individuals with type 2 diabetes who volunteered to participate in the study. As data collection tools, Patient Descriptive Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be used. As a pre-test, data will be collected from all patients at the first interview. Then, web-based training based on the health promotion model will be applied to the individuals in the experimental group 1 and face-to-face training will be applied to the individuals in the experimental group 2. The individuals in the control group will be given routine training applied in the hospital. Reminder messages about foot care will be sent to the patients once a week. After the first application, data from all individuals in experiment group 1, experiment group 2 and control group will be collected again and analyzed in the 1st and 3rd months, and the research will be completed. Power analysis was performed using the G\*Power (v3.1.9.2) program to determine the number of samples. The power of the study is expressed as 1-β (β = probability of type II error), and in general, studies must have 80% power. The number of samples was determined as 135 in total, 45 people in each group.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with type 2 diabetes at least 6 months ago according to ADA criteria
* Being between the ages of 18 and 80
* Ability to read and write
* Not having received diabetic foot training before
* No existing foot ulcers
* Using the Internet (from sources such as smartphone, tablet, computer)
* Being open to communication and collaboration
* No mental problems
* Volunteering to participate in the study

Exclusion Criteria:

* Wants to leave the study
* Foot ulcer development in a diabetic individual during work

Primary outcomes:
measure: Diabetes Foot Knowledge Level
timeFrame: The knowledge level of the patients is measured with the 5-item "Diabetes Foot Knowledge Qustionnare" ; It will be evaluated before the training, in the first month and in the third month after the training.
measure: Foot Care Behavior
timeFrame: Patients' foot care behaviors will be questioned with the "Foot Self Care Observation Guide" consisting of 15 items; It will be evaluated before the training, in the first month and in the third month after the training.
measure: Foot Care Self-Efficacy
timeFrame: Patients' foot care self-efficacy is evaluated with the "Diabetic Foot Care Self Efficacy" consisting of 9 items; It will be evaluated before the training, in the first month and in the third month after the training.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr.Lütfi Kırdar City Hospital
Study officials:
affiliation: Kartal Dr.Lütfi Kırdar City Hospital İstanbul, Turkey
name: Aysun Kürkçü
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahin S, Cingil D. Evaluation of the relationship among foot wound risk, foot self-care behaviors, and illness acceptance in patients with type 2 diabetes mellitus. Prim Care Diabetes. 2020 Oct;14(5):469-475. doi: 10.1016/j.pcd.2020.02.005. Epub 2020 Feb 27.
citation: Pourkazemi A, Ghanbari A, Khojamli M, Balo H, Hemmati H, Jafaryparvar Z, Motamed B. Diabetic foot care: knowledge and practice. BMC Endocr Disord. 2020 Mar 20;20(1):40. doi: 10.1186/s12902-020-0512-y.
citation: Kilic M, Karadag A. Developing and Evaluating a Mobile Foot Care Application for Persons With Diabetes Mellitus: A Randomized Pilot Study. Wound Manag Prev. 2020 Oct;66(10):29-40.
citation: Chau JP, Chung LC, Wong RY, Loo KM, Lo SH, So TT, Lau MS, Yeung TH, Leung BS, Tong ML, Li CY, Kwok WW, Thompson DR, Lee DT. An evaluation of a web-based diabetes education program designed to enhance self-management among patients living with diabetes. Comput Inform Nurs. 2012 Dec;30(12):672-9. doi: 10.1097/NXN.0b013e318261f1d2.
citation: Abrar EA, Yusuf S, Sjattar EL, Rachmawaty R. Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Prim Care Diabetes. 2020 Apr;14(2):104-110. doi: 10.1016/j.pcd.2019.06.005. Epub 2019 Jul 13.