Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-26 @ 3:30 PM
Study NCT ID:
NCT05974592
Status:
UNKNOWN
Last Update Posted:
2023-10-12
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Nurse-Led Diabetic Foot Self-Management Training Program
Sponsor:
Hacettepe University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: