Sickle Cell DiseaseEMPOWER-AYANCT05383911
Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
A study testing SCD Shared Decision-Making Toolkit for AYAs - including VR and SCD Shared Decision-Making Toolkit for AYAs - without VR in people with Sickle Cell Disease, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- SCD Shared Decision-Making Toolkit for AYAs - including VR and SCD Shared Decision-Making Toolkit for AYAs - without VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 30 Jun 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours and their caregivers will be included. Patients must be deemed candidates for initiation of one or more disease-modifying therapies by their SCD healthcare provider.
- Nemours SCD healthcare providers will also be included.
- English language fluency is a requirement for all participants.
Who cannot join
- Patients/ caregivers who previously participated in usability testing of the intervention will be excluded.
- Patients will also be excluded if they have history of seizures, if their medical status or cognitive functioning preclude completion of interviews, or if no legal guardian is available to provide consent (for patients < 18 years).
- Providers still completing training will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
About this study
This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.
- Conditions
- Sickle Cell Disease
- Being tested
- SCD Shared Decision-Making Toolkit for AYAs - including VR, SCD Shared Decision-Making Toolkit for AYAs - without VR
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCD Shared Decision-Making Toolkit for AYAs - including VRBehavioural
The SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including virtual reality, online (videos, animations, articles), and print materials); and 3) implementation (e.g., clinic audit and feedback strategies).
SCD Shared Decision-Making Toolkit for AYAs - without VRBehavioural
The SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including online videos, animations, and articles as well as print materials); and 3) implementation (e.g., clinic audit and feedback strategies).
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making Toolkit including VR | Experimental | Not described Receives: Behavioral: SCD Shared Decision-Making Toolkit for AYAs - including VR |
| Shared Decision Making Toolkit without VR | Experimental | Not described Receives: Behavioral: SCD Shared Decision-Making Toolkit for AYAs - without VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
Questionnaire assessing healthcare provider perspectives on acceptability of the intervention. Total score ranges from 4-20, with higher scores indicating greater acceptability.
Measured: Within 2 weeks post-intervention
Patient/Caregiver Satisfaction Questionnaire
Survey assessing patient/caregiver satisfaction with the intervention. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.
Measured: Within 2 weeks post-intervention
Feasibility of Intervention Measure (FIM)
Questionnaire assessing healthcare provider perspectives on the feasibility of the intervention. Total score ranges from 4-20, with higher scores indicating greater feasibility.
Measured: Within 2 weeks post-intervention
Participant Recruitment Rate
Rate of participant enrollment and retention in the study
Measured: Time of enrollment through study completion, approximately 12 months
Shared Decision Making Questionnaire (SDM-Q-9)
Questionnaire assessing patient- and caregiver-reported engagement in decision making. Total score ranges from 0 to 100, with higher scores indicating greater engagement in decision making.
Measured: Within 2 weeks post-intervention
Disease-Modifying Therapy Knowledge Questionnaire
Questionnaire assessing patient and caregiver knowledge of disease modifying-therapies for sickle cell disease. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.
Measured: Within 2 weeks post-intervention
Secondary outcomes (1)
Initiation of disease-modifying therapy
Proportion of patients who agree to initiate a disease-modifying therapy following use of the shared decision making intervention
Measured: Within 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start26 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimee Hildenbrand, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383911
- Sponsor's protocol ID
- 348507
- Acronym
- EMPOWER-AYA
- Status last verified
- Jun 2026
- First submitted
- 9 May 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
- ClinicalTrials.gov ID
- NCT05383911
- Acronym / sponsor ID
- EMPOWER-AYA / 348507
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 May 2022 (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 study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making Toolkit including VR | Experimental | Behavioral: SCD Shared Decision-Making Toolkit for AYAs - including VR |
| Shared Decision Making Toolkit without VR | Experimental | Behavioral: SCD Shared Decision-Making Toolkit for AYAs - without VR |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours and their caregivers will be included. Patients must be deemed candidates for initiation of one or more disease-modifying therapies by their SCD healthcare provider.
- Nemours SCD healthcare providers will also be included.
- English language fluency is a requirement for all participants.
Key exclusion criteria (3 listed)
- Patients/ caregivers who previously participated in usability testing of the intervention will be excluded.
- Patients will also be excluded if they have history of seizures, if their medical status or cognitive functioning preclude completion of interviews, or if no legal guardian is available to provide consent (for patients < 18 years).
- Providers still completing training will be excluded.
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 |
|---|---|---|
| SCD Shared Decision-Making Toolkit for AYAs - including VRThe SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including virtual reality, online (videos, animations, articles), and print materials); and 3) implementation (e.g., clinic audit and feedback strategies). | Behavioural | Shared Decision Making Toolkit including VR |
| SCD Shared Decision-Making Toolkit for AYAs - without VRThe SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including online videos, animations, and articles as well as print materials); and 3) implementation (e.g., clinic audit and feedback strategies). | Behavioural | Shared Decision Making Toolkit without VR |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: Within 2 weeks post-intervention
Questionnaire assessing healthcare provider perspectives on acceptability of the intervention. Total score ranges from 4-20, with higher scores indicating greater acceptability.
Patient/Caregiver Satisfaction Questionnaire
Time frame: Within 2 weeks post-intervention
Survey assessing patient/caregiver satisfaction with the intervention. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.
Feasibility of Intervention Measure (FIM)
Time frame: Within 2 weeks post-intervention
Questionnaire assessing healthcare provider perspectives on the feasibility of the intervention. Total score ranges from 4-20, with higher scores indicating greater feasibility.
Participant Recruitment Rate
Time frame: Time of enrollment through study completion, approximately 12 months
Rate of participant enrollment and retention in the study
Shared Decision Making Questionnaire (SDM-Q-9)
Time frame: Within 2 weeks post-intervention
Questionnaire assessing patient- and caregiver-reported engagement in decision making. Total score ranges from 0 to 100, with higher scores indicating greater engagement in decision making.
Disease-Modifying Therapy Knowledge Questionnaire
Time frame: Within 2 weeks post-intervention
Questionnaire assessing patient and caregiver knowledge of disease modifying-therapies for sickle cell disease. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.
1 secondary outcome
Initiation of disease-modifying therapy
Time frame: Within 6 months post-intervention
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 16 Jun 2026.
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCD Shared Decision-Making Toolkit for AYAs - including VR and SCD Shared Decision-Making Toolkit for AYAs - without VR in people with Sickle Cell Disease, run by Nemours Children's Clinic at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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 United States. 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?
Contact Clinical Research Coordinator (302-723-9331, benjamin.bear@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: Within 2 weeks post-intervention). The study lists 6 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 16 Jun 2026.