Apply the (MyTransition) App In Transition | NCT03188224

Studies
Apply the (MyTransition) App In Transition

NCT03188224

Sponsor

McMaster University

Status

Completed

Last Update Posted

Sep 26, 2019Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Chronic Health Condition

Interventions

MyTransition app

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2018Actual

Primary Completion Date

Dec 20, 2018Actual

Completion Date

Dec 20, 2018Actual

First Submitted Date

Jun 13, 2017

First Submission Date that Met QC Criteria

Jun 14, 2017

First Posted Date

Jun 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2019

Last Update Posted Date

Sep 26, 2019Actual

Name	Class
Hamilton Academic Health Sciences Organization	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Transition to adult care is an unavoidable and challenging period for patients and their families, and comes with adverse outcomes in experience of care, population health, and costs. Parents of children with chronic conditions report a greater need for support around the time of healthcare transition. Providers report neither having the tools nor appropriate resources to foster smooth transitions for patients and their families. We hypothesize that an app-based transition toolkit (named MyTransition) designed to support youth moving from child to adult care can improve their experiences and lead to better health. The main objective of this study is to collect information to design a large multi-centre randomized control trial to assess implementation of the MyTransition app including recruitment, completion of follow-up, and scale-ability of the intervention. The secondary objective is to assess the feasibility and potential effect of the MyTransition app-based transition toolkit for improving health of youth (quality of life), healthcare transition experience, and achievement of health and life goals.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	MyTransition app	Other: MyTransition app
Control	No Intervention	Usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MyTransition app	Other	MyTransition app is designed to support youth moving from pediatric to adult healthcare.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Completion of Data Collection	Completion rate of 90% for all outcomes.	6-Month Follow-Up

Secondary Outcomes

Measure	Description	Time Frame
Change in Short Form Six-Dimension (SF-6D)	Instrument for describing and valuing individual's health. Will be used to evaluate quality of life.	Baseline, 3-month follow-up, 6-month follow-up

Other Outcomes

Measure	Description	Time Frame
Change in Client Satisfaction Questionnaire (CSQ-8)	Designed to measure satisfaction with health and human services received by individuals and families. Will be used to assess healthcare transition experience.	Baseline, 3-month follow-up, 6-month follow-up
Change in Transition-Q

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Willem Gorter, PhD	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster Children's Hospital		Hamilton	Ontario	L8N 3Z5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

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.