Clinical trial NCT06023810: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Sakarya University
First posted: 2023-09-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Wagner's ulcer classification scale
timeFrame: at 1 week
measure: Wagner's ulcer classification scale
timeFrame: at 8 weeks
measure: Wagner's ulcer classification scale
timeFrame: at 12 weeks
Secondary outcomes:
measure: Diabetic Foot Care Self-Efficacy Scale
timeFrame: at 1 week
measure: Diabetic Foot Care Self-Efficacy Scale
timeFrame: at 8 weeks
measure: Diabetic Foot Care Self-Efficacy Scale
timeFrame: at 12 weeks
measure: Medication Adherence Report Scale
timeFrame: at 1 week
measure: Medication Adherence Report Scale
timeFrame: at 8 weeks
measure: Medication Adherence Report Scale
timeFrame: at 12 weeks
measure: Watson Patient Satisfaction Assessment Form According to Healing Processes
timeFrame: at 8 weeks
Other outcomes:
Locations:
Study officials:
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