To evaluate the impact of implementing a Collaborative Care Model on the quality of life and self-efficacy of students with Type 1 Diabetes.
Design
A double-blind, randomized controlled clinical trial with parallel groups involving 58 diabetic students, utilizing the Sealed Envelope website for randomization.
Settings and conduct
This study will use convenience sampling to recruit participants and employ block random assignment for 58 students with Type 1 Diabetes visiting the educational and medical center of Dezful Big Hospital (Ganjoyan) who meet the inclusion criteria. Participants will be divided into two double-blinded groups of 29.
Participants/Inclusion and exclusion criteria
Students with type 1 diabetes
Intervention groups
The participatory care model in this study consists of four stages: motivation, preparation, engagement, and evaluation.
1.Motivation Stage: Patients will be educated about Type 1 Diabetes and its complications by a multidisciplinary team, including specialists and a family member, aiming to empower them with knowledge for managing their condition.
2.Preparation Stage: Specific educational goals will be set, including program timing and follow-up methods, ensuring patients know what to expect.
3.Engagement Stage: This phase includes five training sessions for the intervention group, focusing on practical skills related to diabetes management to enhance self-efficacy.
4.Evaluation Stage: After the intervention, an evaluation will assess the model's effectiveness by measuring changes in participants’ quality of life and self-efficacy.
Main outcome variables
This model can be implemented in educational and treatment centers to improve the quality of life and self-efficacy of students with Type 1 Diabetes, while preventing long-term complications for patients and families and reducing additional costs for healthcare systems.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241130063895N1
Registration date:2025-01-08, 1403/10/19
Registration timing:registered_while_recruiting
Last update:2025-01-08, 1403/10/19
Update count:0
Registration date
2025-01-08, 1403/10/19
Registrant information
Name
Simin Aghaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 098 7668
Email address
siminaghaee97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of the Collaborative Care Model on Quality of Life and Self-Efficacy Among Students with Type 1 Diabetes: A Randomized Clinical Trial
Public title
Exploring the Collaborative Care Approach for Students with Type 1 Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must be between 12 and 18 years old at the time of enrollment.
Participants must be currently enrolled as students in a primary or secondary school.
Participants must have a caregiver involved in their care and support.
The student and their caregiver must be mentally healthy and free from significant mental illnesses.
Participants must have a confirmed diagnosis of Type 1 diabetes made by a pediatrician.
Participants must have a confirmed diagnosis of Type 1 diabetes made by a pediatrician.
Participants must provide informed consent to participate in the study.
Exclusion criteria:
Individuals who do not meet the inclusion criteria will be excluded.
Individuals with any other chronic illness will be excluded.
If either the child or the caregiver develops a mental illness during the study, they will be excluded.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data and Safety Monitoring Board
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants will be sampled using a convenience method. Subsequently, they will be allocated to two groups through a block randomization technique.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this method, considering the total number of 58 samples and the number of 2 study groups, the block size will be considered as a multiple of 2. Therefore, blocks of 2, 4, and 6 will be selected. Then, based on the online random assignment site, patients will be assigned to the test and comparison groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Motahari Boulevard, Yasouj University of Medical Sciences, Education, Research and Technology Department
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-12-04, 1403/09/14
Ethics committee reference number
IR.YUMS.REC.1403.115
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Quality of Life Questionnaire Score (DQOLY)
Timepoint
Measurement of quality of life score at the beginning of the study (before the intervention) and at the end of the fifth intervention session (sixth session).
Method of measurement
Type 1 Diabetic Adolescent Quality of Life Questionnaire (DQOLY)
2
Description
Self-efficacy questionnaire for diabetic patients
Timepoint
Measuring self-efficacy scores at the beginning of the study (before the intervention) and at the end of the fifth intervention session (sixth session).
Method of measurement
Self-efficacy questionnaire for diabetic patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participatory care model is implemented with researcher management for the intervention group. The participatory care model in this study consists of four stages: motivation, preparation, engagement, and evaluation. Training in the motivation stage is carried out by informing patients about the disease and its dangerous consequences and outcomes with the cooperation of all team members and the client. In the next step, preparation, educational goals and the timing of the education programs and the method of follow-up are determined. Engagement is also implemented by holding 5 training sessions for the intervention group, and then evaluation is carried out after the intervention.
Category
Lifestyle
2
Description
Control group: The control group does not receive any intervention.