Roy Adaptation Model in People With Type 1 Diabetes

NCT ID: NCT05336929

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-12-31

Brief Summary

The study was conducted to determine the effect of Roy adaptation model-based education on disease compliance and metabolic control in adolescents with Type 1 diabetes.

Detailed Description

This study was designed as a randomized controlled study. A total of 60 adolescents, training (n=30) and control (n=30) that meet the research criteria were divided by random method. Pre-training data of the groups were collected using the "Sociodemographic Form", "Diabetes Information Evaluation Form" and "Roy Adaptation Model Interview Form" and HbA1c values were recorded. The training group was trained on the Roy Adaptation Model by a month break, in two sessions. After the training, the adolescents in the training group were given a curvature booklet based on the Roy Adaptation model. The control group was not intervened. After the training, the diabetes Information Assessment Form and the Roy Adaptation Model Discussion Form have applied to both groups again and the values of HbA1c were recorded.

Conditions

Type 1 Diabetes; Adolescent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

education arm (n=30)

Roy adaptation model-based training was given to the training arm.

Group Type: EXPERIMENTAL

Roy adaptation model-based nursing education

Intervention Type: OTHER

control arm (n=30)

Roy adaptation model-based training not given to the training arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Roy adaptation model-based nursing education

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Having type 1 diabetes

2. Must be between the ages of 11-18

3. volunteering for research

Exclusion Criteria

1. Presence of mental disability

2. To have received training on the content of the study

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: collaborator

Balikesir University

OTHER

Sponsor Role: lead

Responsible Party

Gulsah Sunay Ertem

Msc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sibel ergün, Assoc. Dr.

Role: PRINCIPAL_INVESTIGATOR

sibel.ergun@balikesir.edu.tr

Other Identifiers

Balıkesir University

Identifier Type: -

Identifier Source: org_study_id