NCT03188224

Brief Summary

Moving from child care to adult care is a hard time for patients and their families. Parents of children with chronic conditions say they need more support around the time of changing care. Care providers say they do not have the tools to provide smooth transitions or help their patients manage their own health. This study is to see if a smart-phone-based app (named MyTransition) can improve healthcare transition experiences and health outcomes for youth, compared to usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

June 13, 2017

Last Update Submit

September 25, 2019

Conditions

Keywords

TransitionImproved patient outcomesRCTChild healthEmpower youth

Outcome Measures

Primary Outcomes (1)

  • Completion of Data Collection

    Completion rate of 90% for all outcomes.

    6-Month Follow-Up

Secondary Outcomes (1)

  • Change in Short Form Six-Dimension (SF-6D)

    Baseline, 3-month follow-up, 6-month follow-up

Other Outcomes (4)

  • Change in Client Satisfaction Questionnaire (CSQ-8)

    Baseline, 3-month follow-up, 6-month follow-up

  • Change in Transition-Q

    Baseline, 3-month follow-up, 6-month follow-up

  • Change in Transition Readiness Assessment Questionnaire (TRAQ)

    Baseline, 3-month follow-up, 6-month follow-up

  • +1 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

MyTransition app

Other: MyTransition app

Control

NO INTERVENTION

Usual care

Interventions

MyTransition app is designed to support youth moving from pediatric to adult healthcare.

Intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Attending participating clinic at McMaster Children's Hospital
  • Diagnosed with chronic health condition
  • Must be able to utilize the intervention tool
  • Must be able to read and understand English

You may not qualify if:

  • Dependence on caregivers in areas of daily functioning, self-care and/or communication
  • Inability to lead or provide own care
  • Enrolled in a potentially confounding trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Study Officials

  • Jan Willem Gorter, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: After completing the baseline assessment, participants will be randomized into one of two groups: intervention or control. Those in the control group will be thanked for their time and informed that the research coordinator will be in touch to set up the follow-up visits (3- and 6-months following baseline). Those in the intervention group will be provided access to the MyTransition app (intervention). The research coordinator will help them navigate through the app and will instruct them on how to use it. These participants will also receive monthly reminder messages from the research coordinator to promote the use of the app.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

January 25, 2018

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations