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

NCT ID: NCT05983120

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2023-01-03

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.

Conditions

Pre-Existing Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Training group

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

Educate the patients who suffer from Type 2 Diabetes Mellitus

Control Group

The control group received standard training from a diabetes nurse.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

Educate the patients who suffer from Type 2 Diabetes Mellitus

Intervention Type: OTHER

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Çelik

Dr. assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin Celik

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Sibel Karaca Sivrikaya

Role: STUDY_DIRECTOR

Balikesir University

Alper Emre Kurt

Role: STUDY_CHAIR

Afyonkarahisar goverment hospital

Sezen Yılmaz

Role: STUDY_CHAIR

Afyonkarahisar goverment hospital

Locations

Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Afyonkarahisar HSU

Identifier Type: -

Identifier Source: org_study_id