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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
Istanbul Okan Univesitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 10, 2023
    Last Updated
    September 3, 2023
    Sponsor
    Istanbul Okan Univesitesi
    Collaborators
    Sakarya University
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    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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