Chronic Health ConditionApplyITNCT03188224
Apply the (MyTransition) App In Transition
A study testing MyTransition app in people with Chronic Health Condition, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Chronic Health Condition
- What is being tested?
- MyTransition app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Health Condition
- Being tested
- MyTransition app
- Keywords
- Transition, Improved patient outcomes, RCT, Child health, Empower youth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyTransition appOther
MyTransition app is designed to support youth moving from pediatric to adult healthcare.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | MyTransition app Receives: Other: MyTransition app |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Data Collection
Completion rate of 90% for all outcomes.
Measured: 6-Month Follow-Up
Secondary outcomes (1)
Change in Short Form Six-Dimension (SF-6D)
Instrument for describing and valuing individual's health. Will be used to evaluate quality of life.
Measured: Baseline, 3-month follow-up, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start25 Jan 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Health ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Sponsor
- Investigators
- Jan Willem Gorter, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188224
- Sponsor's protocol ID
- ApplyIT Study
- Acronym
- ApplyIT
- Status last verified
- Sep 2019
- First submitted
- 13 Jun 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03188224
- Acronym / sponsor ID
- ApplyIT / ApplyIT Study
- Conditions
- Chronic Health Condition
- Keywords
- Transition, Improved patient outcomes, RCT, Child health, Empower youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MyTransition appMyTransition app |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyTransition appMyTransition app is designed to support youth moving from pediatric to adult healthcare. | Other | Intervention |
Primary outcome
Completion of Data Collection
Time frame: 6-Month Follow-Up
Completion rate of 90% for all outcomes.
1 secondary outcome
Change in Short Form Six-Dimension (SF-6D)
Time frame: Baseline, 3-month follow-up, 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Willem Gorter, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyTransition app in people with Chronic Health Condition, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Data Collection (time frame: 6-Month Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.