The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers
Primary Purpose
Foot Ulcer, Diabetic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Watson's human care theory-based motivational interviewing method
Sponsored by
About this trial
This is an interventional treatment trial for Foot Ulcer, Diabetic
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: - Patients who do not meet the inclusion criteria and those who decline to participate in the study will not be included.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental
control
Arm Description
Watson's human care theory-based motivational interviewing method
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Diabetic Foot Care Self-Efficacy Scale
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Diabetic Foot Care Self-Efficacy Scale
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Diabetic Foot Care Self-Efficacy Scale
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Medication Adherence Report Scale
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Medication Adherence Report Scale
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Medication Adherence Report Scale
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Watson Patient Satisfaction Assessment Form According to Healing Processes
The form consists of a total of six questions. The first five questions are scored on a scale of 1 to 7, with responses ranging from 'never' (1) to 'always' (7).
Full Information
NCT ID
NCT06023810
First Posted
August 10, 2023
Last Updated
September 3, 2023
Sponsor
Istanbul Okan Univesitesi
Collaborators
Sakarya University
1. Study Identification
Unique Protocol Identification Number
NCT06023810
Brief Title
The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers
Official Title
The Effect of Watson's Human Care Theory-Based Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Okan Univesitesi
Collaborators
Sakarya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
According to the International Diabetes Federation (IDF) data, there are currently 425 million adults worldwide affected by diabetes, and it is projected to increase to 578 million by 2030 and 700 million by 2045. The increasing prevalence of diabetes has led to a rise in the frequency of complications arising from diabetes. The escalation in diabetes complications and their consequences is concerning. There is a need for interventions that encourage positive changes in health behaviors among patients and teach better management of diabetes-related complications.
Diabetic foot ulcer, a challenging complication of diabetes, has significant effects on physical, mental, social, and economic well-being, leading to reduced quality of life. It often necessitates prolonged hospitalizations, intensive treatment, and high medical costs. One of the nursing models frequently preferred today is the Human Care Theory, developed by Jean Watson between 1975 and 1979. The Human Care Theory is centered around providing quality care to patients and maintaining effective communication. Motivational Interviewing is a counseling approach developed by clinical psychologists William R. Miller and Stephen Rollnick.
The aim of the study is to investigate the impact of Watson's human care theory-based motivational interviewing method on treatment adherence, self-efficacy, and satisfaction in individuals with diabetic foot ulcers. In this study, a randomized controlled experimental-control group experimental design will be used. The population of the study consists of patients who applied to Kocaeli Derince Training and Research Hospital Internal Medicine outpatient clinics between June and October 2023, diagnosed with type 1 and type 2 diabetes mellitus, with first degree diabetic foot wound according to the Wagner classification. With the power analysis program G-Power 3.1.9.2, the sample size was calculated as 38 people (76) in each group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental
Arm Type
Experimental
Arm Description
Watson's human care theory-based motivational interviewing method
Arm Title
control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Watson's human care theory-based motivational interviewing method
Other Intervention Name(s)
Pre-post test
Intervention Description
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
Primary Outcome Measure Information:
Title
Wagner's ulcer classification scale
Description
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.
Time Frame
at 1 week
Title
Wagner's ulcer classification scale
Description
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.
Time Frame
at 8 weeks
Title
Wagner's ulcer classification scale
Description
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.
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
Diabetic Foot Care Self-Efficacy Scale
Description
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Time Frame
at 1 week
Title
Diabetic Foot Care Self-Efficacy Scale
Description
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Time Frame
at 8 weeks
Title
Diabetic Foot Care Self-Efficacy Scale
Description
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Time Frame
at 12 weeks
Title
Medication Adherence Report Scale
Description
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Time Frame
at 1 week
Title
Medication Adherence Report Scale
Description
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Time Frame
at 8 weeks
Title
Medication Adherence Report Scale
Description
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Time Frame
at 12 weeks
Title
Watson Patient Satisfaction Assessment Form According to Healing Processes
Description
The form consists of a total of six questions. The first five questions are scored on a scale of 1 to 7, with responses ranging from 'never' (1) to 'always' (7).
Time Frame
at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria and those who decline to participate in the study will not be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nida Efetürk
Phone
+905303030850
Email
nidaunal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşe Çevirme
Phone
+905363237836
Email
acevirme@sakarya.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers
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