Clinical trial NCT05628259: The Effect of Tele-Nursing Based Motivational Interviewing in Individuals With Type 2 Diabetes:RCT
Official title: The Effect of Tele-Nursing Based Motivational Interviewing on Diabetes Self-Efficacy, Diabetes Self-Management and Metabolic Control Parameters in Individuals With Type 2 Diabetes: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Self Efficacy
Self Management
Tele-nursing
Motivational Interview
LDL - Low Density Lipoprotein Receptor Disorder
High Density Lipoprotein Deficiency
Cholesterol; Lipidosis
Lead sponsor: Pamukkale University
Sponsor class: OTHER
Collaborators: name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
First posted: 2022-11-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel group randomized controlled study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study carried out to examine the effect of tele-nursing based motivational interviewing on diabetes self-efficacy, diabetes self-management and metabolic control parameters (Body mass index, waist circumference, HbA1c%,fasting blood glucose, LDL cholesterol, HDL cholesterol, total cholesterol, triglyceride) in individuals with type 2 diabetes.

Detailed description: The first researcher of the article who applied Motivational Interviewing Techniques has a "Motivational Interviewing Techniques Training" certificate. A motivational interview (MI) program based on the telenursing approach was prepared by the researchers based on the literature for the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.

Eligibility criteria: Inclusion Criteria:

1) being over 18 years old, 2) receiving insulin or insulin + oral therapy, 3) diagnosis of type 2 diabetes at least one year ago, 4) having a BMI of 25 and above, 5) HbA1c value of 7 and above, 6) access to phone, 7) voluntarily agreeing to participate in the study.

Exclusion Criteria:

1) have a physical disability.

Primary outcomes:
measure: Diabetes Self-Efficacy Scale
timeFrame: Change from Baseline diabetes self-efficacy at 6 months
measure: Diabetes Self-Management Scale
timeFrame: Change from Baseline diabetes self-management at 6 months
Secondary outcomes:
measure: HbA1c%
timeFrame: Change from Baseline HbA1c% at 6 months
measure: BMI
timeFrame: Change from Baseline Body Mass Index at 6 months
measure: FBG
timeFrame: Change from Baseline Fasting glucose at 6 months
measure: LDL
timeFrame: Change from Baseline LDL at 6 months
measure: HDL
timeFrame: Change from Baseline HDL at 6 months
measure: waist circumference
timeFrame: Change from Baseline waist circumference at 6 months
measure: Total cholesterol
timeFrame: Change from Baseline total cholesterol at 6 months
measure: Triglyceride
timeFrame: Change from Baseline total triglyceride at 6 months
Other outcomes:
Locations:
city: Pamukkale
country: Turkey
facility: Eda Kılınç İşleyen
state: Denizli
city: Istanbul
country: Turkey
facility: İrem Nur ÖZDEMİR
city: Istanbul
country: Turkey
facility: Şengül AYDIN YOLDEMİR
Study officials:
affiliation: Uşak University
name: Eda KILINÇ İŞLEYEN, PhD. RN.
role: STUDY_CHAIR
References: