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

NCT05974592 | Unknown

• 1 other identifier: 145/10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

diabetic foot; Patient Education; Foot Care; Self-Efficacy; Nurse

Outcome Measures

Primary Outcomes (3)

• Diabetic Foot Care Self-Efficacy Scale (DABS)

  It is a Likert-type scale developed by Quarles in 2005 in accordance with western culture to determine the self-perception of diabetic patients in performing diabetic foot care activities. Self-efficacy is measured by scoring between 0 and 10. The scale consists of 9 items. The 9 statements that make up the scale are evaluated on the 11-digit visual scale, which is stated as "I'm not sure = 0 and very sure = 10". The lowest score of the scale is 0, and the highest score is 90. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases. The Cronbach's alpha value of the sub-dimensions of the scale was 0.94. The validity and reliability study of the scale in the Turkish population was carried out by Kir Bicer and Enc (2014), and the Cronbach alpha value was found to be 0.86.

  It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.

• Diabetic Foot Knowledge Scale (DABI)

  The Turkish validity-reliability study of the scale developed by Alexandra et al.(2001) to evaluate the diabetic foot information of diabetic patients was conducted by Biçer and Enç (2011). The scale consists of 5 items. Diabetic foot knowledge is evaluated using a 5-item DABÖ, a subscale. The Cronbach alpha value of the Turkish version of the scale was 0.58.

  It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.

• Foot Care Behavior Scale (USAS)

  There are 16 items in the scale developed by Borges (2007) in line with the criteria of the American Diabetes Association (ADA) in order to improve foot care behaviors in patients with diabetes (51). The Turkish validity and reliability study was conducted by Kır Biçer and Enç (2014), and it was adapted as a 15-item Foot Care Behavior Scale in line with expert opinions. Each item in the scale is rated on a Likert-type scale between 1 (never) and 5 (always do). The lowest score that can be obtained from the scale is 15; the highest score is 75; High scores indicate that foot care behavior is sufficient. The Cronbach's alpha value for the Turkish version of the scale was found to be 0.83 (high reliability).

  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 (1)

• Diabetic Foot Evaluation Form (DADF)

  It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Education

Control Group

NO INTERVENTION

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.

Interventions

Education OTHER

Diabetic Foot Self-Management Training Program will be implemented.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Ayşe Arıkan Dönmez

CONTACT

+903123051580; aysearikan8585@gmail.com

Emine Çelik Polat, PhD

CONTACT

+905315907186; celikemine995@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)