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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04172077
Other study ID # 1000059604
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2019
Est. completion date January 30, 2020

Study information

Verified date July 2021
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project will assess self-efficacy levels(SE) ,resiliency and attachment style of adolescent with type 1 diabetes and their caregivers.SE and attachment style of patients and parents will be compared with each other as well as correlated with diabetes management as assessed by A1C and self inventory scale.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date January 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - T1DM patients age 12 - 18 yrs from Sick Kids Diabetes Clinic and a primary caregiver - T1DM > 1yr and able to communicate in English Exclusion Criteria: - Families who cannot communicate in English (read, write, speak) - Diagnosed less than 1 year diabetes - Transient form of Diabetes (such as medication induced diabetes) - Exclude type 2 Diabetes and CFRD (cystic fibrosis related diabetes)

Study Design


Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Examine the effects of patients' attachment styles (secure, mixed and fearful) on their type one diabetes management represented by A1C level The following tool will be used - Relationship Scale Questionnaire (RSQ): The 30-item RSQ is valid and reliable. 76 Re-test reliability of the RSQ ranged from 0.54 to 0.78 and correlation coefficients of RSQ and RQ ranged from 0.41 to 0.6191.
Adolescent Relationship Scale Questionnaire (A-RSQ): Sümer & Güngör (1999) used the A-RSQ and report validity of 0.7-0.95 as well as an internal consistency of 0.82.
25 minutes
Secondary a) Effect of attachment style on self efficacy level in patients. The following tool will be used - Self-Efficacy of Diabetes Self-Management (SEDM): This is a 10-item questionnaire that is used to assess perceived self-efficacy to preform diabetes care behaviours. Respondents are asked to score responses on a 1-10 Likert scale in which '1= not at all sure' to '10= completely sure'. 25 minutes
Secondary a) Effect of attachment style on self efficacy level in parents. The following tool will be used - Self-Efficacy of Diabetes Self-Management (SEDM): This is a 10-item questionnaire that is used to assess perceived self-efficacy to preform diabetes care behaviours. Respondents are asked to score responses on a 1-10 Likert scale in which '1= not at all sure' to '10= completely sure'. 25 minutes
Secondary b)Compare diabetes management self-efficacy and attachment style in patients. To compare diabetes self-efficacy (SEDM) in patients and their parents, paired t-tests will be calculated. In addition, to compare attachment styles in patients and their parents, McNemar's test will be used. Paired t-tests and McNemar's tests effectively take into account the correlations between parent-adolescent measures from the same family. 25 minutes
Secondary b)Compare diabetes management self-efficacy and attachment style in parents To compare diabetes self-efficacy (SEDM) in patients and their parents, paired t-tests will be calculated. In addition, to compare attachment styles in patients and their parents, McNemar's test will be used. Paired t-tests and McNemar's tests effectively take into account the correlations between parent-adolescent measures from the same family. 25 minutes
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