Clinical trial NCT05974592: The Effect of Nurse-Led Diabetic Foot Self-Management Training Program
Official title: The Effect of Nurse-Led Diabetic Foot Self-Management Training Program on Diabetic Foot Knowledge, Foot Care Behavior, and Self-Efficacy Levels in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Keywords: diabetic foot
Patient Education
Foot Care
Self-Efficacy
Nurse
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Diabetic foot is one of the most important chronic complications of Diabetes Mellitus (DM), which is a global health problem today. Diabetic foot not only affects the individual's quality of life, body image, role performance, and social and economic structure of the family and society but also creates a serious burden on the individual's family and health system. Therefore, some approaches that include foot and nail care, shoe and sock(s) selection, nutrition, and exercise practices are recommended to prevent diabetic foot and to increase functional capacity, without the need for surgical treatment. It is crucial to maintain these recommended approaches throughout the patient's life to ensure effective management of the diabetic foot. This study aims to determine the effect of the nurse-led diabetic foot self-management training program on diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2 DM. This study was planned in a randomized controlled design. The population of the study will consist of type 2 DM patients who do not use insulin therapy and who applied to University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital Diabetes outpatient clinic and Diabetes Education outpatient clinic between September 2022 and September 2023. According to the power analysis, 38 participants are targeted to be reached in total. Data will be collected with a Personal Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale, Diabetic Foot Care Self-Efficacy Scale, and Diabetic Foot Evaluation Form. As a result of this study, it is expected that the nurse-led diabetic foot self-management training program will increase the diabetic foot knowledge, foot care behavior and self-efficacy levels of diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2 DM.

Detailed description: The data to be obtained from the research will be evaluated by transferring them to the IBM SPSS (Statistical Packages for the Social Sciences) Statistics 23 program. Descriptive statistics for continuous variables (mean, standard deviation, median, minimum, maximum), frequency distribution will be used for categorical variables. Differences between categorical variables will be evaluated with Chi-square test and Fisher Exact test, and relations between numerical variables will be evaluated with Spearman Correlation Analysis. The conformity of the data to the normal distribution will be evaluated with the Shapiro Wilk test of normality and Q-Q graphs. Accordingly, if the parametric test assumptions are met, the Significance Test of the Difference Between Two Means in the comparison of independent group differences; If the parametric test assumptions cannot be met, the Mann-Whitney U test will be used. In dependent group comparisons, if parametric test assumptions are met, Analysis of Variance in Repeated Measurements and Significance Test of Difference Between Two Spouses; Friedman Test and Wilcoxon Paired Two Sample Test will be used when parametric test assumptions are not met. A value of p ≤ 0.05 will be considered statistically significant in all analyses.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Having Type 2 DM for 1 year or more,
* HbA1C level of 7.5% and below,
* Not using insulin therapy,
* Able to use WhatsApp himself or his relatives
* Individuals who volunteer to participate in the research will be included in the research.

Exclusion Criteria:

* Pregnant or having a pregnancy plan,
* Mental or cognitive impairment
* Having a diabetic foot diagnosis confirmed by a physician,
* Individuals with advanced complications (retinopathy, nephropathy, peripheral arterial disease, etc.) associated with DM diagnosed by a physician

Primary outcomes:
measure: Diabetic Foot Care Self-Efficacy Scale (DABS)
timeFrame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
measure: Diabetic Foot Knowledge Scale (DABI)
timeFrame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
measure: Foot Care Behavior Scale (USAS)
timeFrame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
Secondary outcomes:
measure: Diabetic Foot Evaluation Form (DADF)
timeFrame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: