Roy Adaptation Model in People With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes, Adolescent
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Roy adaptation model-based nursing education
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes
Eligibility Criteria
Inclusion criteria:
- Having type 1 diabetes
- Must be between the ages of 11-18
- volunteering for research
Exclusion criteria
- Presence of mental disability
- To have received training on the content of the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
education arm (n=30)
control arm (n=30)
Arm Description
Roy adaptation model-based training was given to the training arm.
Roy adaptation model-based training not given to the training arm
Outcomes
Primary Outcome Measures
HbA1c values
change from baseline in HbA1c value at 3 months
Secondary Outcome Measures
Diabetes Knowledge Level
change from baseline in diabetes knowledge level on the 32 points diabetes knowledge level form at month 2
Full Information
NCT ID
NCT05336929
First Posted
March 23, 2022
Last Updated
April 19, 2022
Sponsor
Balikesir University
Collaborators
Uludag University
1. Study Identification
Unique Protocol Identification Number
NCT05336929
Brief Title
Roy Adaptation Model in People With Type 1 Diabetes
Official Title
Effect of Roy Adaptation Model on Metabolic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balikesir University
Collaborators
Uludag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Adolescent
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
education arm (n=30)
Arm Type
Experimental
Arm Description
Roy adaptation model-based training was given to the training arm.
Arm Title
control arm (n=30)
Arm Type
No Intervention
Arm Description
Roy adaptation model-based training not given to the training arm
Intervention Type
Other
Intervention Name(s)
Roy adaptation model-based nursing education
Primary Outcome Measure Information:
Title
HbA1c values
Description
change from baseline in HbA1c value at 3 months
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Diabetes Knowledge Level
Description
change from baseline in diabetes knowledge level on the 32 points diabetes knowledge level form at month 2
Time Frame
baseline and 2nd month
Other Pre-specified Outcome Measures:
Title
Roy Adaptation Model Interview results
Description
Change of adaptation behavior to illness consisting of 27 questions in 2 months
Time Frame
baseline and 2nd month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Having type 1 diabetes
Must be between the ages of 11-18
volunteering for research
Exclusion criteria
Presence of mental disability
To have received training on the content of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sibel ergün, Assoc. Dr.
Organizational Affiliation
sibel.ergun@balikesir.edu.tr
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Roy Adaptation Model in People With Type 1 Diabetes
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