NCT06655116

Brief Summary

To determine the effect of foot care training given according to Interpersonal Relationship Theory on foot care behaviour and diabetic foot self-efficacy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 16, 2024

Last Update Submit

October 21, 2024

Conditions

Keywords

Diabetic FootDiabetes MellitusPatient Education

Outcome Measures

Primary Outcomes (3)

  • Descriptive Information Form:

    The descriptive information form, which was created by the researchers by reviewing the literature, consists of 16 items in total, including seven questions about individual characteristics (age, gender, height, weight, education level, family structure, smoking) and nine questions about the disease and diabetic foot (HbA1c value, number of years of living with diabetes, treatment(s) received, history of diabetic foot).

    2 Minutes

  • Diabetic Foot Self-Care Behaviour Scale

    The Diabetic Outpatient Self-Care Behaviour Scale was developed by Yen-Fan Chin and Tzu-Ting Huang in 2013 (Chin \& Huang, 2013). The Turkish validity and reliability study conducted by Bakır and Samancıoğlu Bağlama was published in 2021. The scale is a five-point Likert-type scale consisting of 7 items and two sections. The first part consists of four items including practices related to examining, washing and drying the soles of the feet and toes during the week. The three items in the second section are related to the use of shoes and lotion. The lowest score that can be obtained from the first section is 4 and the highest score is 20. The lowest score that can be obtained from the second section is 3 and the highest score is 15. The questionnaire is evaluated over the total score and the score that can be obtained varies between 7-35. As the score obtained from the scale increases, self-care behaviour increases.

    5 minutes

  • Diabetic Foot Care Self-Efficacy Scale

    The scale consisting of nine items is answered with an 11-digit visual scale ranging from 0-10. In the answers, the lowest value is expressed as 'I do not consider it sufficient at all' and the highest value is expressed as 'I consider it very sufficient'. The scale has no sub-dimensions and is evaluated on the total scale score. The lowest score that can be obtained from the scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.

    5 minutes

Study Arms (2)

Control Group

Study Grup

Behavioral: Diabetic Foot Education

Interventions

Patients in the intervention group will be interviewed and their diabetic foot knowledge will be evaluated. During the interview, the individual's knowledge about the definition of diabetic foot, risk factors, symptoms, treatment, complications, care and prevention will be evaluated. In order to systematically plan, implement and evaluate the training to be used in the intervention, it is aimed to implement androgogical training based on the 'Interpersonal Relations Theory'. In this context, the stages in the theory will be followed as follows.

Study Grup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Erciyes University Health Application and Research Centre

You may qualify if:

  • Over 18 years of age,
  • Diagnosis of Type 2 DM for at least 6 months,
  • Not having received planned diabetic foot training before,
  • Volunteering to participate in the study,

You may not qualify if:

  • Neuropsychiatric drug use and disease that may affect education (Dementia- Alzheimer's and Mental Retardation etc.)
  • Being visually impaired,
  • Hearing impairment,
  • Inability to speak Turkish,
  • Presence of active diabetic foot ulcer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Talas, 38030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Res. Asst. PhD

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 23, 2024

Study Start

October 26, 2024

Primary Completion

November 26, 2024

Study Completion

December 26, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations