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Apply the (MyTransition) App In Transition (ApplyIT)

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ClinicalTrials.gov Identifier: NCT03188224
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Hamilton Academic Health Sciences Organization
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Chronic Health Condition Other: MyTransition app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: Intervention
MyTransition app
Other: MyTransition app
MyTransition app is designed to support youth moving from pediatric to adult healthcare.

No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Completion of Data Collection [ Time Frame: 6-Month Follow-Up ]
    Completion rate of 90% for all outcomes.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Nadilein Mahlberg, MSc 905-525-9140 ext 27548 mahlbn@mcmaster.ca
Contact: Jan Willem Gorter, PhD 905-525-9140 ext 27855 gorter@mcmaster.ca

Locations
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Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Nadilein Mahlberg, MSc    905-525-9140 ext 27548    mahlbn@mcmaster.ca   
Contact: Jan Willem Gorter, PhD    905-525-9140 ext 27855    gorter@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Hamilton Academic Health Sciences Organization
Investigators
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Principal Investigator: Jan Willem Gorter, PhD McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03188224     History of Changes
Other Study ID Numbers: ApplyIT Study
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
Transition
Improved patient outcomes
RCT
Child health
Empower youth

Additional relevant MeSH terms:
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Disease
Pathologic Processes