Youth with Multimorbidity or Rare DieasesNCT06583525
Evaluation of the TAC Program
A study testing Intensive Transition Support in people with Youth with Multimorbidity or Rare Dieases, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This is a mixed-methods evaluative study examining the effectiveness of the Transition to Adult Care Program at the Hospital for Sick Children (TAC) Program on high-risk youth with medical and psychosocial complexity transitioning to adult and/or primary care services. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Youth with Multimorbidity or Rare Dieases
- What is being tested?
- Intensive Transition Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 16 Aug 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 16-18 years old and have a complex medical history, as defined by:
- Clinical Characteristics: Multi-morbidity (≥ 3 long-term chronic physical and/or mental health conditions (with primary condition being a physical health condition AND/OR Rare disease/ genetic condition.
- High Risk: No clearly identified adult provider/services following transfer AND/OR experiencing significant barriers related to Social and Structural Determinants of Health.
Who cannot join
- Moderate to severe developmental/intellectual disabilities
- Followed by services at SickKids which has an established transition program/provider
- Does not provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Transition to Adult Care (TAC) Program for High-Risk Youth with Multimorbidity or Rare Disease: a Prospective Observation Cohort Study
This is a mixed-methods evaluative study examining the effectiveness of the Transition to Adult Care Program at the Hospital for Sick Children (TAC) Program on high-risk youth with medical and psychosocial complexity transitioning to adult and/or primary care services.
The overarching aim is to study the effectiveness of a new interdisciplinary and holistic Transition to Adult Care Program (TAC) on health-related outcomes for high-risk youth with multimorbidity or rare diseases and their caregivers by:
- Assess the effect of the TAC program on the youth's transition readiness, self-efficacy, self-management, health-related quality of life, and satisfaction.
- Assess the effect of the TAC program on the caregiver's satisfaction.
- Explore the experiences, perceptions, needs, and priorities of youth and caregivers participating in the TAC program using qualitative research methods.
- Describe the feasibility of the TAC program (defined as success in patient recruitment, attendance, participation, retention and transfer).
- Being tested
- Intensive Transition Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Transition SupportOther
A multidisciplinary transition team (nurse practitioner and social worker) will coordinate the transition process for each patient across multiple settings, focused on the youth's highest priority needs while also supporting the caregivers. Participants will receive case management and care navigation using an intensive transition support model provided through the partnership of a transition team. The transition team will collaborate with the participants existing care team to help coordinate care, provide consultation, and support adult and primary care accepting these youth for 1 year following the transfer. This Intervention is modelled on best practices by Health Quality Ontario's Quality Standards for Transition from Youth to Adult Health Care Services to support youth at high risk of having poor transitional outcomes as they move from pediatric to adult care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Intensive Transition Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Identification and Transition Readiness
The change in the patients demonstration of their self-management skills and transition readiness will be assessed using the Transition Readiness Assessment Questionnaire (20-item survey). A scoring of 4 or more across all domains is considered an indicator of transition readiness.
Measured: Baseline,12 months and 24 months
Early Identification and Transition Readiness
The change in the patients self-efficacy in their ability to manage their health and demonstrate transition readiness will be assessed using the General Self-Efficacy Scale (10 item survey). A total score is achieved from a range of 10 to 40, with high scores as an indication of better perceived general self-efficacy.
Measured: Baseline,12 months and 24 months
Early Identification and Transition Readiness
The change in the patients knowledge and confidence in their ability to manage their health and demonstrate transition readiness will be assessed using the Patient Activation Measure (10-item survey). An average net 6-point score increase demonstrating improvement
Measured: Baseline,12 months and 24 months
Early Identification and Transition Readiness - Service Satisfaction
The change in the patients and caregivers satisfaction with transitional health care services will be measured using the Larsen Client Satisfaction Questionnaire (8-item survey).
Measured: Baseline,12 months and 24 months
Information Sharing and Support
The transition intervention will include providing the patients and caregivers with information on available needs-based services and support. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Measured: 6 to 24 months
Information Sharing and Support
The transition intervention will include offering support from the time of discharge from pediatric services until the first appointment with adult services. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Measured: 6 to 24 months
Transition Plan
The transition intervention will include the co-creating an individualized transition plan to identify the patients transition goals and set timelines. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Measured: 6 to 24 months
Coordinated Transition
The transition intervention will include developing a patient-specific transfer package. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Measured: 6 to 24 months
Introduction to Adult Services
A joint clinic visit will be facilitated by the transition team with the identified receiving adult care provider. The number of patients who have received a warm handover visit with the transition team, primary care provider/service team, will be assessed via report in the patients medical record.
Measured: 24 to 36 months
Transition Completion
Successful transfer will be measured by the attendance of the first appointment with a primary care and/or subspecialty adult care provider between the first 6 to 12 months of transfer from the pediatric provider.
Measured: 24 to 36 months
Health-Related Quality of Life
The change in the patients quality of life will be measured using the The Pediatric Quality of Life Inventory 4.0 Generic Core Scale Teen Report The 23-item survey will assess four core health dimensions (physical functioning, emotional functioning, social functioning and school functioning) transformed into total scores ranging from 0 to 100. An increase in 12 and 24 months follow-up scores from baseline will be measured.
Measured: Baseline, 12 months and 24 months
Experience in the process
Semi-structured qualitative interviews will be conducted with a subset of participants to explore participants; experiences working with the transition team, and satisfaction with the tools and resources used.
Measured: 24 to 36 months
Secondary outcomes (1)
Program Feasibility
The successful implementation of the intervention will be evaluated by assessing the feasibility of the program. The percentage of attended appointments, completed questionnaires, individualized transition plans created, warm handovers completed prior to participants' 18th birthday, and additional clinic visits required will be documented for each participant.
Measured: 24 to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start16 Aug 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Youth with Multimorbidity or Rare DieasesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alene Toulany, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583525
- Sponsor's protocol ID
- 1000081574
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Transition to Adult Care (TAC) Program for High-Risk Youth with Multimorbidity or Rare Disease: a Prospective Observation Cohort Study
- ClinicalTrials.gov ID
- NCT06583525
- Acronym / sponsor ID
- 1000081574
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Sep 2024 (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.
This is a mixed-methods evaluative study examining the effectiveness of the Transition to Adult Care Program at the Hospital for Sick Children (TAC) Program on high-risk youth with medical and psychosocial complexity transitioning to adult and/or primary care services.
The overarching aim is to study the effectiveness of a new interdisciplinary and holistic Transition to Adult Care Program (TAC) on health-related outcomes for high-risk youth with multimorbidity or rare diseases and their caregivers by:
- Assess the effect of the TAC program on the youth's transition readiness, self-efficacy, self-management, health-related quality of life, and satisfaction.
- Assess the effect of the TAC program on the caregiver's satisfaction.
- Explore the experiences, perceptions, needs, and priorities of youth and caregivers participating in the TAC program using qualitative research methods.
- Describe the feasibility of the TAC program (defined as success in patient recruitment, attendance, participation, retention and transfer).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intensive Transition Support |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical Characteristics: Multi-morbidity (≥ 3 long-term chronic physical and/or mental health conditions (with primary condition being a physical health condition AND/OR Rare disease/ genetic condition.
- High Risk: No clearly identified adult provider/services following transfer AND/OR experiencing significant barriers related to Social and Structural Determinants of Health.
Key exclusion criteria (3 listed)
- Moderate to severe developmental/intellectual disabilities
- Followed by services at SickKids which has an established transition program/provider
- Does not provide consent
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 |
|---|---|---|
| Intensive Transition SupportA multidisciplinary transition team (nurse practitioner and social worker) will coordinate the transition process for each patient across multiple settings, focused on the youth's highest priority needs while also supporting the caregivers. Participants will receive case management and care navigation using an intensive transition support model provided through the partnership of a transition team. The transition team will collaborate with the participants existing care team to help coordinate care, provide consultation, and support adult and primary care accepting these youth for 1 year following the transfer. This Intervention is modelled on best practices by Health Quality Ontario's Quality Standards for Transition from Youth to Adult Health Care Services to support youth at high risk of having poor transitional outcomes as they move from pediatric to adult care. | Other | Intervention |
Primary outcome
Early Identification and Transition Readiness
Time frame: Baseline,12 months and 24 months
The change in the patients demonstration of their self-management skills and transition readiness will be assessed using the Transition Readiness Assessment Questionnaire (20-item survey). A scoring of 4 or more across all domains is considered an indicator of transition readiness.
Early Identification and Transition Readiness
Time frame: Baseline,12 months and 24 months
The change in the patients self-efficacy in their ability to manage their health and demonstrate transition readiness will be assessed using the General Self-Efficacy Scale (10 item survey). A total score is achieved from a range of 10 to 40, with high scores as an indication of better perceived general self-efficacy.
Early Identification and Transition Readiness
Time frame: Baseline,12 months and 24 months
The change in the patients knowledge and confidence in their ability to manage their health and demonstrate transition readiness will be assessed using the Patient Activation Measure (10-item survey). An average net 6-point score increase demonstrating improvement
Early Identification and Transition Readiness - Service Satisfaction
Time frame: Baseline,12 months and 24 months
The change in the patients and caregivers satisfaction with transitional health care services will be measured using the Larsen Client Satisfaction Questionnaire (8-item survey).
Information Sharing and Support
Time frame: 6 to 24 months
The transition intervention will include providing the patients and caregivers with information on available needs-based services and support. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Information Sharing and Support
Time frame: 6 to 24 months
The transition intervention will include offering support from the time of discharge from pediatric services until the first appointment with adult services. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Transition Plan
Time frame: 6 to 24 months
The transition intervention will include the co-creating an individualized transition plan to identify the patients transition goals and set timelines. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Coordinated Transition
Time frame: 6 to 24 months
The transition intervention will include developing a patient-specific transfer package. The number of patients who receive this intervention will be assessed via report in the patients medical record.
Introduction to Adult Services
Time frame: 24 to 36 months
A joint clinic visit will be facilitated by the transition team with the identified receiving adult care provider. The number of patients who have received a warm handover visit with the transition team, primary care provider/service team, will be assessed via report in the patients medical record.
Transition Completion
Time frame: 24 to 36 months
Successful transfer will be measured by the attendance of the first appointment with a primary care and/or subspecialty adult care provider between the first 6 to 12 months of transfer from the pediatric provider.
Health-Related Quality of Life
Time frame: Baseline, 12 months and 24 months
The change in the patients quality of life will be measured using the The Pediatric Quality of Life Inventory 4.0 Generic Core Scale Teen Report The 23-item survey will assess four core health dimensions (physical functioning, emotional functioning, social functioning and school functioning) transformed into total scores ranging from 0 to 100. An increase in 12 and 24 months follow-up scores from baseline will be measured.
Experience in the process
Time frame: 24 to 36 months
Semi-structured qualitative interviews will be conducted with a subset of participants to explore participants; experiences working with the transition team, and satisfaction with the tools and resources used.
1 secondary outcome
Program Feasibility
Time frame: 24 to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Transition Support in people with Youth with Multimorbidity or Rare Dieases, run by The Hospital for Sick Children 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 3 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: enrolling by invitation, as of the sponsor's last update on 4 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Early Identification and Transition Readiness (time frame: Baseline,12 months and 24 months). The study lists 12 primary outcomes in all. 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 4 Sep 2024.