The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers

NCT06023810 | Completed

• 1 other identifier: IstanbulOkanU-N-EFETURK-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Given this context, there is a clear necessity for interventions that motivate patients to adopt beneficial health behaviors and educate them in effectively managing diabetes-related complications. This study seeks to investigate the impact of Watson's motivational interviewing method, which is grounded in the human care theory, on enhancing treatment adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic foot ulcers. Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education, and those who receive standard education. H1: There is a difference in self-efficacy for diabetic foot care between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education. H2: There is a difference in diabetic foot care behavior between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education. H3: There is a difference in treatment adherence between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education. H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (3)

• Wagner's ulcer classification scale

  The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.

  at 1 week

• Wagner's ulcer classification scale

  The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.

  at 8 weeks

• Wagner's ulcer classification scale

  The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.

  at 12 weeks

Secondary Outcomes (7)

• Diabetic Foot Care Self-Efficacy Scale

  at 1 week

• Diabetic Foot Care Self-Efficacy Scale

  at 8 weeks

• Diabetic Foot Care Self-Efficacy Scale

  at 12 weeks

• Medication Adherence Report Scale

  at 1 week

• Medication Adherence Report Scale

  at 8 weeks

Study Arms (2)

experimental

EXPERIMENTAL

Watson's human care theory-based motivational interviewing method

Behavioral: Watson's human care theory-based motivational interviewing method

control

NO INTERVENTION

Interventions

Watson's human care theory-based motivational interviewing method BEHAVIORAL

The Motivational Interviewing Program based on Watson's Theory of Human Caring will be conducted over an 8-week period, with sessions taking place once a week. The initial session will have a duration of 60 minutes, while the subsequent weekly sessions will last for 30 minutes

Also known as: Pre-post test

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with clear consciousness,
• No communication problems,
• Diagnosed with type 1 or type 2 diabetes,
• Grade 1 diabetic foot ulcer according to the Wagner classification,
• Receiving standard wound care,
• Residing in the Kocaeli province,
• No musculoskeletal or neurological disorders that could interfere with the study,
• Individuals willing to participate and who sign the informed consent form.

Sponsors & Collaborators

• Okan University: lead
• Sakarya University: collaborator

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Evaluation Studies as Topic

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)

Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 5, 2023
• Study Start: March 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 30, 2023
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)