Transition of youth with type 1 diabetes from pediatric to adult diabetes care with a transition coordinator using communication technologies
| ISRCTN | ISRCTN13459962 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13459962 |
- Submission date
- 20/01/2020
- Registration date
- 22/01/2020
- Last edited
- 14/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
1820 Richmond Road SW
Calgary
T2T 5C7
Canada
| Phone | +1 (0)4039558327 |
|---|---|
| sbutalia@ucalgary.ca |
Study information
| Study design | Multi-center open-label non-randomized multicentre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Transition of youth with type 1 diabetes with a technology-enhanced transition coordinator |
| 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(s) | 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 |
| 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 |
| 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 study start date | 01/01/2013 |
| Overall study end date | 01/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 142 |
| Total final enrolment | 303 |
| 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 exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/01/2013 |
| Recruitment end date | 31/08/2016 |
Locations
Countries of recruitment
- Canada
Study participating centres
Calgary
T3B 6A8
Canada
Calgary
T2T 5C7
Canada
Calgary
T1Y 6J4
Canada
Calgary
T2P 3C5
Canada
Sponsor information
University/education
2500 University Drive NW
Calgary
T2N 1N4
Canada
| Phone | +1 (0)403 220 5110 |
|---|---|
| sbutalia@ucalgary.ca | |
| Website | https://www.ucalgary.ca/ |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Canada
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2021 | 14/01/2021 | Yes | No |
Editorial Notes
14/01/2021: Publication reference added.
22/01/2020: Trial's existence confirmed by Conjoint Health Research Ethics Board.
