The Effect of Nurse-Led Diabetic Foot Self-Management Training Program

NCT ID: NCT05974592

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-01-30

Brief Summary

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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

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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.

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention Group

To the participants in the intervention group; the "Diabetic Foot Self-Management Training Program (DFSMTP)" will be implemented. Printed, visual, and audio training materials will be used within this training program's scope. Training will be held in the Diabetes Education Room in line with the content of DFSMTP prepared by the researcher after determining the appropriate day and time with the participants. Written (training booklet) and visual (computer and PowerPoint presentation) training materials will be used during this training. The printed training booklet will be delivered to the participants at the end of the training. DFSMTP will be held in three sessions on the same day. In order to reinforce the learning of the participants in the intervention group, DFSMTP will also be video recorded with the presentation of the researcher and this recording will be transferred to the DFSMTP YouTube channel to be created by the researcher.

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

Diabetic Foot Self-Management Training Program will be implemented.

Control Group

To the participants in the control group; General information about the anatomy and physiology of the pancreas will be explained with the verbal lecture technique. Participants in this group will receive the training only once. Following the completion of the research, the printed training booklet and YouTube channel link information will be shared with the participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education

Diabetic Foot Self-Management Training Program will be implemented.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Emine Celik Polat

Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşe Arıkan Dönmez

Role: CONTACT

+903123051580 ext. 149

Emine Çelik Polat, PhD

Role: CONTACT

+905315907186

Facility Contacts

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AYŞE ARIKAN DÖNMEZ, PhD

Role: primary

+903123051580 ext. 149

EMİNE ÇELİK POLAT

Role: backup

+905315907186

Other Identifiers

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145/10

Identifier Type: -

Identifier Source: org_study_id

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