Roy Adaptation Model in People With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Effect of Roy Adaptation Model on Metabolic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336929
• Other study ID #: Balikesir University
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2022
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Roy adaptation model-based nursing education

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Balikesir University	Uludag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Roy Adaptation Model Interview results	Change of adaptation behavior to illness consisting of 27 questions in 2 months	baseline and 2nd month
Primary	HbA1c values	change from baseline in HbA1c value at 3 months	3 month
Secondary	Diabetes Knowledge Level	change from baseline in diabetes knowledge level on the 32 points diabetes knowledge level form at month 2	baseline and 2nd month