Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/01/2020
Date assigned
22/01/2020
Last edited
22/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The transition from pediatric to adult diabetes care is associated with high rates of medical follow-up dropout. Young adults with type 1 diabetes may be difficult to engage through traditional modes of communication. This study aims to address this care gap by using a technology-enhanced transition coordinator, a liaison between patients and healthcare services, to facilitate seamless care during the transition period.

Who can participate?
Youth with type 1 diabetes aged 17 or 18

What does the study involve?
A transition coordinator connects with young adults with type 1 diabetes using communication technologies commonly used by this age group, including texting, email and social media. The researchers assess the impact of a technology-enhanced transition coordinator by comparing a group of young adults with diabetes who had access to this service to a group who did not.

What are the possible benefits and risks of participating?
It is hoped that this intervention will reduce the number of young adults with diabetes who fall out of medical follow-up. This study will provide crucial information that will help improve care practices for this vulnerable population. The possible risk to consider is the threat to privacy and confidentiality with new communication technologies. In order to contain this risk, the researchers will be working closely with the Privacy Office to ensure that they take all measures possible to protect patients’ privacy.

Where is the study run from?
Alberta Children’s Hospital (Canada)

When is the study starting and how long is it expected to run for?
January 2013 to March 2019

Who is funding the study?
The Lawson Foundation (Canada)

Who is the main contact?
Dr Sonia Butalia
sbutalia@ucalgary.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sonia Butalia

ORCID ID

Contact details

1820 Richmond Road SW
Calgary
T2T 5C7
Canada
+1 (0)4039558327
sbutalia@ucalgary.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Transition of youth with type 1 diabetes with a technology-enhanced transition coordinator

Acronym

Study hypothesis

It is hypothesized that the technology-enhanced transition coordinator will reduce loss to follow up in youth with type 1 diabetes transitioning from pediatric to adult diabetes care.

Ethics approval

Approved 17/11/2014, Conjoint Health Research Ethics Board (CHREB) (Research Services Office, 2500 University Drive, NW, Calgary AB T2N 1N4, Canada; Tel: +1 (403) 220-2297; Email: chreb@ucalgary.ca), ID #REB14-1158

Study design

Multi-center open-label non-randomized multicentre clinical trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Type 1 diabetes

Intervention

The usual care group was a historical group not exposed to the transition coordinator for a period equivalent to the intervention prior to the start of the intervention. The intervention group had the transition coordinator role established as “standard of care for all patients” attending pediatric clinics for the period of the intervention.

Both usual care and intervention groups received routine diabetes and transition care as per national diabetes guidelines. Usual care included regular appointments with their pediatric diabetes care team (endocrinologist, diabetes nurse, dietician and on an as needed with a psychologist and/or a social worker) and transition discussions starting at age 14. The intervention group was provided additional support by way of a non-medical transition coordinator during the transition and transfer from pediatric to adult diabetes care. The transition coordinator role included the: use of text messaging or email communication (as per participant’s preference) every 2 months and as needed by participants, communication with pediatric and adult diabetes teams regarding emergency visits or hospitalizations, and supporting participants (i.e. completion of forms, finding a family doctor, psychosocial resources). The intervention group were also encouraged to use a transition website and were invited to join a private Facebook® page moderated by the transition coordinator. The transition coordinator met in person with individuals at least 6 months prior to referral to adult diabetes care and continued their support for 12 months past the transfer date. Both usual care and intervention groups had routine adult diabetes care which included their endocrinologist and as needed visits with a diabetes educator and/or a dietician. Follow up was for 18 months post transfer for both study arms.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Proportion of participants that did not attend at least one routine clinic visit in adult diabetes care within 1 year after transfer

Secondary outcome measures

Measured at 12 and 18 months post-transfer:
1. Diabetes-related clinical outcomes (i.e., hemoglobin A1c, albumin:creatinine ratio (ACR), number of A1c's, number of ACRs, emergency department visits and hospitalizations for diabetic ketoacidosis)
2. Quality of life measured using Diabetes Self-Efficacy questionnaire, Problem Areas in Diabetes questionnaire, Diabetes Quality of life for Youth questionnaire, and a program satisfaction questionnaire

Overall trial start date

01/01/2013

Overall trial end date

01/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of type 1 diabetes according to the American Diabetes Association for at least the last 6 months
2. Aged 17 to 18 years
3. Had been seen by their pediatric endocrinologist in the last 12 months
4. In the last year of pediatric care and transitioning to an adult care site in the city within the next year
5. A Personal Health Number (PHN) for data linkage

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

142

Total final enrolment

303

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2013

Recruitment end date

31/08/2016

Locations

Countries of recruitment

Canada

Trial participating centre

Alberta Children's Hospital
28 Oki Drive NW
Calgary
T3B 6A8
Canada

Trial participating centre

Diabetes Centre
1820 Richmond Road SW
Calgary
T2T 5C7
Canada

Trial participating centre

Peter Lougheed Hospital
3500 26 Avenue NE
Calgary
T1Y 6J4
Canada

Trial participating centre

Associate's Clinic
401-9 Avenue SW
Calgary
T2P 3C5
Canada

Sponsor information

Organisation

University of Calgary

Sponsor details

2500 University Drive NW
Calgary
T2N 1N4
Canada
+1 (0)403 220 5110
sbutalia@ucalgary.ca

Sponsor type

University/education

Website

https://www.ucalgary.ca/

Funders

Funder type

Charity

Funder name

Lawson Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Canada

Results and Publications

Publication and dissemination plan

The researchers plan to publish the study protocol and statistical analysis. The trial (including focus groups that informed the intervention) results will be disseminated through presentations, conferences and peer-reviewed journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sonia Butalia (sbutalia@ucalgary.ca). The data will be in anonymized form and in numerical format. The data will become available within 2-4 weeks of request and sent electronically with password protection and encryption. The data will be available for the analyses conducted in this study and for up to five years post study completion. The ethical and legal restrictions are as per the researchers' Institution (The University of Calgary; www.ucalgary.ca and its ethics board for human research, the Conjoint Health Research Ethics Board).

Intention to publish date

01/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/01/2020: Trial's existence confirmed by Conjoint Health Research Ethics Board.