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Group Education Trial to Improve Transition in Type 1 Diabetes (GET-IT-T1D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703440
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
St. Justine's Hospital
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Meranda Nakhla, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE October 9, 2018
First Posted Date  ICMJE October 12, 2018
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE November 19, 2019
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Hemaglobin A1c (HbA1c) [ Time Frame: 0, 12, 24 months ]
HbA1c will be measured using an A1c Test Kit, which is a non-fasting, finger stick, whole blood test
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Hemaglobin A1c (HbA1c) [ Time Frame: 0, 12, 24 months ]
HbA1c will be measured using an AccuBase A1c Test Kit, which is a non-fasting, finger stick, whole blood test
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Delay in establishing adult Diabetes Care (gap in care>6 months) [ Time Frame: 24 months ]
    Delay greater than 6 months (Y/N) between the last Diabetes Care visit with a pediatric care physician and the first Diabetes Care visit with an adult care physician will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
  • Delay in establishing adult Diabetes Care (days) [ Time Frame: 24 months ]
    Time in days between the last Diabetes Care visit with a pediatric care physician and the first Diabetes Care visit with an adult care physician will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
  • Diabetes-related hospitalizations [ Time Frame: 0, 12, 24 months ]
    Any diabetes-related hospitalizations in the past 12 months, expressed as number of hospitalizations per person-years (P-Y) at risk will be derived from the Hospital Discharge Database (Med-Echo) and medical record chart
  • Diabetes-related emergency department visits [ Time Frame: 0, 12, 24 months ]
    Any diabetes-related emergency-department visits in the past 12 months, expressed as number of emergency department visits per person-years (P-Y) at risk will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
  • Severe hypoglycemic events [ Time Frame: 0,12, 24 months ]
    Any patient-reported severe hypoglycemic events in the past 12 months
  • Stigma [ Time Frame: 0,12, 24 months ]
    Presence of stigma defined as an affirmative response to at least one of 3 key items on the Barriers to Diabetes Adherence in Adolescence (BDA) questionnaire stigma subscale (score >2 on a 5-point Likert-type scale)
  • Self-efficacy [ Time Frame: 0,12, 24 months ]
    Self-efficacy for Diabetes Self-Management Measure (SEDM) assesses self-efficacy. The score ranges from 1 to 10. All item scores are averaged to compute the score. A higher score represents a better outcome.
  • Diabetes knowledge [ Time Frame: 0, 12, 24 months ]
    L'Aide aux Jeunes Diabétiques Diabetes Knowledge and Skills Questionnaire assesses diabetes knowledge. The score ranges from 0 to 50. The number of correct items are summed to compute the score. A higher score represents a better outcome.
  • Transition readiness [ Time Frame: 0, 12 months ]
    Am I ON TRAC? For Adult Care Questionnaire (Youth Version of Questionnaire) measures transition readiness. Scores range from 13 to 64 on the Knowledge Scale. Item scores are summed to compute the Knowledge Scale score. Higher scores on the Knowledge Scale represent a better outcome. Raw scores range from 8 to 45 on the Behaviour Index. Item scores are summed to compute the raw scores on the Behaviour Index. Higher raw scores on the Behaviour Index represent a better outcome. Cut-off scores range from 0 to 9 on the Behaviour Index. Threshold scores are summed to compute the cut-off scores on the Behaviour Index. Higher cut-off scores on the Behaviour Index represent a better outcome.
  • Diabetes distress [ Time Frame: 0, 12, 24 months ]
    Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) measures diabetes-related distress. The Total Score ranges from 1 to 6. All item scores are averaged to compute the Total Score. A higher Total Score represents a worse outcome. Scores range from 1 to 6 on the 7 Subscales (1. Powerlessness, 2. Management Distress, 3. Hypoglycemia Distress, 4. Negative Social Perceptions, 5. Eating Distress, 6. Physician Distress, 7. Friend/Family Distress) and Screener. Item scores are averaged to compute the Subscale and Screener scores. Higher Subscale and Screener scores represent a worse outcome.
  • Quality of life (Generic Core) [ Time Frame: 0, 12, 24 months ]
    Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale assesses Health-Related Quality of Life. Scores are transformed on a scale from 0 to 100. The Scale Scores (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) range from 0 to 100. To create Scale Scores, the mean is computed as the sum of the items over the number of items answered. Higher Scale Scores represent a better outcome. To create the Psychosocial Health Summary Score, the mean is computed as the sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales. The Physical Health Summary Score is the same as the Physical Functioning Scale Score. The Total Scale Score ranges from 0 to 100. To create the Total Scale Score, the mean is computed as the sum of all the items over the number of items answered on all the Scales. A higher Total Scale Score represents a better outcome.
  • Quality of life (Diabetes Module) [ Time Frame: 0, 12, 24 months ]
    Pediatric Quality of Life Inventory (PedsQL) Diabetes Module assesses diabetes-specific quality of life. Scores are transformed on a scale from 0 to 100. The Scale Scores by Dimension (About My Diabetes, Treatment-I, Treatment II, Worry, and Communication) range from 0 to 100. To calculate Scale Scores by Dimension, the mean is computed as the sum of the items over the number of items answered. Higher Scale Scores represent a better outcome. To calculate the Total Score, the mean is computed as the sum of all the items over the number of items answered on all the Scales. A higher Total Score represents a better outcome.
  • Cost effectiveness (HbA1c) [ Time Frame: 12 and 24 months ]
    Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for HbA1c
  • Cost effectiveness (QOL) [ Time Frame: 12 and 24 months ]
    Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for QOL
  • Cost effectiveness (self-efficacy) [ Time Frame: 12 and 24 months ]
    Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for self-efficacy
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Delay in establishing adult Diabetes Care (gap in care>6 months) [ Time Frame: 24 months ]
    Delay greater than 6 months (Y/N) between the last Diabetes Care visit with a pediatric care physician and the first Diabetes Care visit with an adult care physician will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
  • Delay in establishing adult Diabetes Care (days) [ Time Frame: 24 months ]
    Time in days between the last Diabetes Care visit with a pediatric care physician and the first Diabetes Care visit with an adult care physician will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
  • Diabetes-related hospitalizations [ Time Frame: 0, 12, 24 months ]
    Any diabetes-related hospitalizations in the past 12 months, expressed as number of hospitalizations per person-years (P-Y) at risk will be derived from the Hospital Discharge Database (Med-Echo) and medical record chart
  • Diabetes-related emergency department visits [ Time Frame: 0, 12, 24 months ]
    Any diabetes-related emergency-department visits in the past 12 months, expressed as number of emergency department visits per person-years (P-Y) at risk will be derived from the Physician Service Claims Database (RAMQ) and medical record chart
  • Severe hypoglycemic events [ Time Frame: 0,12, 24 months ]
    Any patient-reported severe hypoglycemic events in the past 12 months
  • Stigma [ Time Frame: 0,12, 24 months ]
    Presence of stigma defined as an affirmative response to at least one of 3 key items on the Barriers to Diabetes Adherence in Adolescence (BDA) questionnaire stigma subscale (score >2 on a 5-point Likert-type scale)
  • Self-efficacy [ Time Frame: 0,12, 24 months ]
    Self-efficacy for Diabetes Self-Management Measure (SEDM)
  • Diabetes knowledge [ Time Frame: 0, 12, 24 months ]
    L'Aide aux Jeunes Diabétiques Diabetes Knowledge and Skills (AJD DKS) Questionnaire
  • Transition readiness [ Time Frame: 0, 12 months ]
    Am I ON TRAC? For Adult Care Questionnaire (TRAQ)
  • Diabetes distress [ Time Frame: 0, 12, 24 months ]
    Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)
  • Quality of life (Generic Core) [ Time Frame: 0, 12, 24 months ]
    Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
  • Quality of life (Diabetes Module) [ Time Frame: 0, 12, 24 months ]
    Pediatric Quality of Life Inventory (PedsQL) Diabetes Module
  • Cost effectiveness (HbA1c) [ Time Frame: 12 and 24 months ]
    Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for HbA1c
  • Cost effectiveness (QOL) [ Time Frame: 12 and 24 months ]
    Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for QOL
  • Cost effectiveness (self-efficacy) [ Time Frame: 12 and 24 months ]
    Cost-effectiveness of group education visits compared with usual care in terms of incremental cost effectiveness ratio (ICER) for self-efficacy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Education Trial to Improve Transition in Type 1 Diabetes
Official Title  ICMJE Evaluation of a Group Education Program to Improve the Transition From Pediatric to Adult Care for Emerging Adults With Type 1 Diabetes
Brief Summary The investigators will conduct a randomized controlled trial (RCT) to examine group education visits as an innovative and potentially cost-effective approach to transition care delivery, that can be easily integrated into usual diabetes care. Among emerging adults with type 1 diabetes (T1D), the investigators aim to assess the effect of group education visits integrated into pediatric care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures after the transfer to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment.
Detailed Description

Rationale. The transition from pediatric to adult diabetes care is a challenging period for adolescents and emerging adults (ages 18-30 years) with type 1 diabetes (T1D). It is characterized by a deterioration in glycemic control (Hemoglobin A1c [HbA1c]), decreased adherence to self-management tasks and to clinic attendance and an increased risk of adverse outcomes. The investigators propose to examine group education visits as a potentially cost-effective approach. In emerging adults with T1D, the investigators hypothesize that group education visits, as compared with usual care, will result in better HbA1c, less adverse outcomes and better psychosocial outcomes after the transfer to adult care.

Primary Aim. To determine the impact of group educations visits, compared with usual care, on HbA1c after the transfer to adult care.

Secondary Aims. 1. To determine the impact of group education visits, compared with usual care, on time between last pediatric and first adult T1D visit (gap > 6 months), emergency department (ED) visits and hospitalizations, severe hypoglycemic events, stigma, self-efficacy, disease knowledge, transition readiness, quality of life (QOL) and diabetes distress, after the transfer to adult care. 2. To determine the cost-effectiveness of group education visits.

Methods. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Patients will be recruited over 24 months. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio . Visits in the active arm will consist of a group education session followed by an individual appointment with the diabetes care physician every 3-months. The group education session, facilitated by a diabetes nurse educator or dietitian, will consist of a patient-driven discussion on topics relevant to adolescents with T1D. Patients in the control group, will have in parallel with the intervention group, individual appointments with their diabetes provider as per usual care. The primary outcome is the change in HbA1c measured at 24 months (HbA1c measured at 24 months - HbA1c measured at baseline). Secondary outcomes are delays in establishing adult T1D care (Y/N), T1D-related hospitalizations and ED-visits (rates/P-Y), severe hypoglycemic events, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, and QOL. Assessments are at baseline, 12 and 24 months . Analysis will be by intention to treat. Outcomes will be calculated and compared between the two trial arms using differences with 95% Confidence Intervals, along with a cost-effectiveness analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Active arm: Patients randomized to the active arm will be asked to attend ≥ 3 group education sessions, in addition to their usual diabetes clinic visits every 3 months, over the 12-month intervention period. Group education sessions will coincide with regularly scheduled clinic visits.

Control arm: Patients randomized to usual care will attend their usual 3-month interval diabetes clinic visits, over the 12-month intervention period, which consists of visits with their diabetes care physician.

Masking: Single (Outcomes Assessor)
Masking Description:
Data analysts
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Type1diabetes
  • Insulin Dependent Diabetes
Intervention  ICMJE
  • Other: Active arm
    ≥3 group education sessions in addition to usual diabetes care, every 3 months for 12 months
  • Other: Control arm
    Usual diabetes care, every 3-month for 12 months
Study Arms  ICMJE
  • Experimental: Active
    ≥3 group education sessions (60 minutes per session) in addition to usual diabetes care, every 3 months for 12 months. Each group session (3-8 patients per group) will be facilitated by a diabetes nurse educator and/or dietitian. The group session content will be guided by the needs of the group participants. The group discussion will end with participants setting goals for their next appointment.
    Intervention: Other: Active arm
  • Control
    Usual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual diabetes care, an individual education session and written information will be provided before formal transfer.
    Intervention: Other: Control arm
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
212
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adolescents with a diagnosis of Type 1 Diabetes
  • 16 to 17 years of age
  • Receiving diabetes care at one of two university teaching hospital-based pediatric diabetes clinics in Montreal: Montreal Children's Hospital (MCH) or Centre Hospitalier Universitaire Sainte Justine (CHUSJ)
  • Fluent in English or French

Exclusion Criteria:

  • Severe neurocognitive disabilities that may preclude patient's ability to participate in a group education visit
  • Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elise Mok, PhD 514-412-4400 ext 23527 elise.mok@muhc.mcgill.ca
Contact: Jennifer Frei, BA 514-412-4400 ext 23868 jennifer.frei@muhc.mcgill.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03703440
Other Study ID Numbers  ICMJE MP-37-2019-4434
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data supporting the results reported in the published research articles, after de-identification will be available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: The data will be available immediately following article publication and ending 5 years after article publication.
Access Criteria: Data will be shared with researchers who provide a scientifically sound proposal that has been approved by an independent Institutional Review Board and for analyses that addresses the aims specified in the proposal (e.g. for individual participant data meta-analysis). Proposals should be submitted to meranda.nakhla@mcgill.ca. Data requestors will need to sign a data access agreement. Data will be available up to 5 years following article publication at (Link to be included).
Responsible Party Meranda Nakhla, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE
  • St. Justine's Hospital
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Meranda Nakhla, MD, MSc Montreal Children's Hospital - McGill University Health Centre (MUHC)
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP