İNSÜLİN: Training on Using ıInsulin in Patients With Type 2 Diabetes

Sponsor

Inonu University (Other)

Overall Status

Completed

CT.gov ID

NCT05915338

Collaborator

(none)

Enrollment

Location

5.9

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was conducted to evaluate the effect of individual insulin use training given to patients with type 2 diabetes using insulin on safe drug administration, pain level and perception of treatment. The study was conducted between October 2022 and March 2023 with a randomized control group.

Condition or Disease	Intervention/Treatment	Phase
Insulin Dependent Diabetes Diabetes type2

Detailed Description

Objective: The aim of this study was to examine the effects of individual insulin use training given to patients with Type 2 diabetes on safe drug administration, pain level and treatment perception, and to contribute to both national and international literature.

Method: It was conducted between October 2022 and March 2023 as a randomized controlled study in a pre-test-post-test order to determine the effect of individual insulin use education given to patients with type 2 diabetes on safe drug administration, pain level and treatment perception. The data were collected by the researchers with the descriptive information form of the patients, the Insulin Administration Skill Observation Form, the Visual Analogue Scale and the Insulin Therapy Evaluation Scale.

Data Collection: Face-to-face and individual interviews with patients who applied to the Internal Diseases and Endocrinology Polyclinic and Diabetes Nursing Polyclinics of a state hospital in a city located in the Southeastern Anatolia Region of Turkey, and who were hospitalized in the Internal Diseases, Endocrinology, Physical Therapy and Rehabilitation and Cardiology Services. collected using the method. A pilot study was not conducted before starting the study. Before the study, all patients were informed about the study and their verbal and written consents were obtained.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

84 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

The Eof ıInsulin Use Education on Safe Drug Administration, Pain Level and Perception of Treatment in Patients With Type 2 Diabetes

Actual Study Start Date :

Oct 1, 2022

Actual Primary Completion Date :

Jan 5, 2023

Actual Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental Group -Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. Afterwards, individual insulin use training was given and the "Educational Manual on the Use of Insulin for Individuals with Type 2 Diabetes" was given to the patients and the first follow-up was completed. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. The ability of the patients to administer the insulin dose was recorded by the researchers as the 3rd follow-up retention test in IUBGF.
Control Group -Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in IUBGF as the 3rd follow-up retention test by the researchers.

Arm

Intervention/Treatment

Experimental Group

-Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. Afterwards, individual insulin use training was given and the "Educational Manual on the Use of Insulin for Individuals with Type 2 Diabetes" was given to the patients and the first follow-up was completed. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. The ability of the patients to administer the insulin dose was recorded by the researchers as the 3rd follow-up retention test in IUBGF.

Control Group

-Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in IUBGF as the 3rd follow-up retention test by the researchers.

Outcome Measures

Primary Outcome Measures

Fırst follow - up survey [Fırst test-fırst applıcatıon both groups at the begınnıng of the research]
Pretest data was obtained using the introductory information form, IASOF, VAS, and ITES. Patients were requested to apply their daily dose of insulin to themselves and patients' application skills were recorded by the researchers into IASOF as the 1st observation.

Secondary Outcome Measures

Last test survey [2 weeks after the fırst watch]
Posttest data was obtained through the use of IASOF, VAS, and ITES. Patients were requested to apply their insulin dose of the day to themselves. Patients' insulin application skills were recorded by researchers into IASOF as the 2nd observation.

Other Outcome Measures

Durabılıty test for both groups [After 8 weeks, the follow-up test was done to both groups]
Posttest data was obtained through the use of IASOF, VAS, and ITES. Patients were requested to apply their insulin dose of the day to themselves. Patients' insulin application skills were recorded by researchers into IASOF as the 3rd observation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients included in the study;

18 years and over Using insulin injections for at least six months or longer
Meeting the American Diabetes Association (ADA, 2021) diagnostic criteria for Type 2 diabetes
No communication and mental problems
Insulin injection made by himself or his family The patients who agreed to participate in the study.

Exclusion Criteria:

Patients excluded from the study;

Self or family member health personnel Those with advanced retinopathy, nephropathy, neuropathy
Diagnosed with type 1 diabetes
Pregnant or breastfeeding women
Patients who participated in another clinical trial concurrently or within 1 month prior to the start of the trial.