Apply the (MyTransition) App In Transition (ApplyIT)
|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: NCT03188224|
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Health Condition||Other: MyTransition app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||An App-based Transition Toolkit Targeting Youth With Chronic Health Conditions: A Randomized Trial as a Foundation to Improve Healthcare Transition and Outcomes|
|Actual Study Start Date :||October 11, 2017|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||March 31, 2019|
Other: MyTransition app
MyTransition app is designed to support youth moving from pediatric to adult healthcare.
No Intervention: Control
- Completion of Data Collection [ Time Frame: 6-Month Follow-Up ]Completion rate of 90% for all outcomes.
- Change in Short Form Six-Dimension (SF-6D) [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up ]Instrument for describing and valuing individual's health. Will be used to evaluate quality of life.
- Change in Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up ]Designed to measure satisfaction with health and human services received by individuals and families. Will be used to assess healthcare transition experience.
- Change in Transition-Q [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up ]Measures transition readiness/self-management ability. Will be used to evaluate readiness for transition.
- Change in Transition Readiness Assessment Questionnaire (TRAQ) [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up ]Patient-centered questionnaire that providers and families use to assess youths' ability to make appointments, to understand their medications, and to develop other skills needed for transition to adult care. Will be used to evaluate readiness for transition.
- Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline, 3-month follow-up, 6-month follow-up ]Designed to measure satisfaction with health and human services received by individuals and families. Will be used to determine achievement of health and life goals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188224
|Contact: Nadilein Mahlberg, MSc||905-525-9140 ext email@example.com|
|Contact: Jan Willem Gorter, PhD||905-525-9140 ext firstname.lastname@example.org|
|McMaster Children's Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Contact: Nadilein Mahlberg, MSc 905-525-9140 ext 27548 email@example.com|
|Contact: Jan Willem Gorter, PhD 905-525-9140 ext 27855 firstname.lastname@example.org|
|Principal Investigator:||Jan Willem Gorter, PhD||McMaster University|