Clinical trial NCT05983120: Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus
Official title: The Effect of Education Provided According to Social Cognitive Learning Theory on Diabetes Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Existing Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
Social Cognitive Learning
Diabetes Self-management
Quality of Life
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study was conducted in order to study the effect of the training given according to social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life among type 2 diabetes mellitus individuals.

Detailed description: The study was done as a randomized-controlled experimental study at Internal Diseases Polyclinics of Afyonkarahisar Public Hospital between November 2021 and August 2022. The study was completed with 60 patients -experimental group (30 patients) and control group (30 patients)- who met inclusion criteria. The data were gathered using Information Request Form and Metabolic Variables Form, Diabetes Self-Management Scale (DSMS) for Type 2 Diabetic Patients, Multidimensional Scale of Perceived Social Support (MSPSS), Type 2 Diabetes Mellitus Self-Management Questionnaire (SMQ), WHOQOL-BREF (WHO- Quality of Life Scale- Short form). A theoretical and practical training based on SCLT was provided to the experimental group for the first five weeks -one module for each week- through power point presentations and afterwards, SMS reminders were sent every fifteen days for seven weeks and at the end of the twelfth week the training was completed. The control group received a standard training from diabetes nurse. The data were assessed using statistical methods.

Eligibility criteria: Inclusion Criteria:

* 18 years and over
* Being diagnosed with Type 2 diabetes mellitus,
* Being on insulin therapy,
* Being open to verbal communication,
* Being literate
* Not to have an obstacle to continue the implementation phase of the research (for example, pregnancy plan, changing province, etc.)
* Not having hearing-vision problems and diabetes-related serious neuropathy (amputation, etc.),
* Patients who agreed to participate in the study.

Exclusion Criteria:The patient has a perception disorder and psychiatric disorder that prevents communication,

* Being pregnant,
* Individuals with serious complications such as retinopathy and neuropathy at the level of blindness were excluded from the study.

Research Termination Criteria

* Not performing the specified applications properly during the study,
* Unreachable in follow-ups,
* Those who want to quit working,
* Serious complications related to comorbid diseases and diabetes that occur during the working process,
* The study was terminated with patients who were moved out of the province during the study.

Primary outcomes:
measure: Determination of self-regulation capacity from the principles of SCLT.
timeFrame: twelve weeks
measure: Determination of self-judgment capacity, one of the principles of SCLT.
timeFrame: twelve weeks
measure: Determining the effect of SCLT-based education on Quality of Life
timeFrame: twelve weeks
Secondary outcomes:
measure: Determination of blood HbA1c value.
timeFrame: twelve weeks
measure: Determination of Fasting Blood Glucose (FBS) value.
timeFrame: twelve weeks
measure: Determination of blood Postprandial Blood Glucose (PBS) value.
timeFrame: twelve weeks
measure: Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values.
timeFrame: twelve weeks
Other outcomes:
measure: Determining the principle of mutual determination from the principles of the social cognitive learning theory (SCLT)
timeFrame: twelve weeks
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Yasemin Celik
role: PRINCIPAL_INVESTIGATOR
affiliation: Balikesir University
name: Sibel Karaca Sivrikaya
role: STUDY_DIRECTOR
affiliation: Afyonkarahisar goverment hospital
name: Alper Emre Kurt
role: STUDY_CHAIR
affiliation: Afyonkarahisar goverment hospital
name: Sezen Yılmaz
role: STUDY_CHAIR
References: