Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus

NCT05983120 | Completed

• 1 other identifier: Afyonkarahisar HSU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Existing Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes; Social Cognitive Learning; Diabetes Self-management; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Determination of self-regulation capacity from the principles of SCLT.

  There is no specific score range.High scores on the scale indicate good self-management (SMQ), and low scores indicate poor self-management. In the intervention group, no significant change was observed in SMQ general score averages between PT2 and IT values compared to PT1. Similarly, no significant change was observed in PT2 values compared to PT1 regarding the control group score averages.

  twelve weeks

• Determination of self-judgment capacity, one of the principles of SCLT.

  DM was assessed with the Self-Efficacy Scale (DSMS). The lowest score that can be obtained from the scale is 20, and the highest score is 100. In the sample, the scale score average is calculated and individuals who are above the average are evaluated as high self-efficacy, and individuals below the average are evaluated as low self-efficacy. In the study, while the overall median score of DSMS in the intervention group showed a significant decrease in PT2 and IT values compared to PT1, no significant change was observed in the median DSMS scores of the control group.

  twelve weeks

• Determining the effect of SCLT-based education on Quality of Life

  Evaluated by WHOQOL - BREF (World Health Organization Quality of Life Scale - Short Form). It has four sub-dimensions: physical health such as pain, sleep, energy, psychological health such as positive emotions, self-confidence, body image, social relations such as social support, personal relations and environmental health such as economic status, transportation, safe environment and health conditions. A high score indicates a high quality of life. In the intervention group, no significant change was observed in the median values of physical health, psychological health, social relations, and environmental health, which are WHOQOL subscales, in PT2 and IT values compared to PT1. Compared to PT1 regarding the median score of the control group's social relations, a minimum significant increase was observed in PT2 values, but no significant change was found in other subscales

  twelve weeks

Secondary Outcomes (4)

• Determination of blood HbA1c value.

  twelve weeks

• Determination of Fasting Blood Glucose (FBS) value.

  twelve weeks

• Determination of blood Postprandial Blood Glucose (PBS) value.

  twelve weeks

• Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values.

  twelve weeks

Other Outcomes (1)

• Determining the principle of mutual determination from the principles of the social cognitive learning theory (SCLT)

  twelve weeks

Study Arms (2)

Training group

EXPERIMENTAL

In the first five weeks, the experimental group was given training consisting of five modules, accompanied by power point presentations and applied social cognitive learning theory, then SMS reminders were sent every fortnight for seven weeks, and the study was completed at the end of the twelfth week. The control group received standard training from a diabetes nurse. Scale evaluations, metabolic and anthropometric measurements were made at the beginning and end of the study in the experimental and control groups. In addition, the scale evaluation was repeated in the fifth week for the experimental group. Data were evaluated using appropriate statistical methods.

Other: Education

Control Group

NO INTERVENTION

The control group received standard training from a diabetes nurse.

Interventions

Education OTHER

Educate the patients who suffer from Type 2 Diabetes Mellitus

Training group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Yasemin Celik

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

• Sibel Karaca Sivrikaya

  Balikesir University

  STUDY DIRECTOR

• Alper Emre Kurt

  Afyonkarahisar goverment hospital

  STUDY CHAIR

• Sezen Yılmaz

  Afyonkarahisar goverment hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. assistant professor

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: August 9, 2023
• Study Start: August 19, 2021
• Primary Completion: August 20, 2022
• Study Completion: January 3, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)