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Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA) (EMPOWER-AYA)

Primary Purpose

Sickle Cell Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shared Decision Making Intervention
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sickle Cell Disease

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours or ChristianaCare 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 and ChristianaCare SCD healthcare providers will also be included.
  • English language fluency is a requirement for all participants.

Exclusion Criteria:

  • Patients/ caregivers who previously participated in usability testing of the intervention will be excluded.
  • Patients will also be excluded 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Shared Decision Making Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    Participant Recruitment Rate
    Rate of participant enrollment and retention in the study
    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.
    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.

    Secondary Outcome Measures

    Initiation of disease-modifying therapy
    Proportion of patients who agree to initiate a disease-modifying therapy following use of the shared decision making intervention

    Full Information

    First Posted
    May 9, 2022
    Last Updated
    June 5, 2023
    Sponsor
    Nemours Children's Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05383911
    Brief Title
    Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
    Acronym
    EMPOWER-AYA
    Official Title
    Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nemours Children's Clinic

    4. Oversight

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

    5. Study Description

    Brief 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). 30 AYAs with SCD (ages 15-25 years) and their caregivers and 10 healthcare providers will participate in the single-arm pilot trial. Study procedures for this future clinical trial will be specified once intervention development, usability testing, and implementation planning phases (currently underway) have been completed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sickle Cell Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Shared Decision Making Intervention
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Shared Decision Making Intervention
    Intervention Description
    We are currently developing a shared decision making intervention for AYAs with SCD to provide decision supports for disease-modifying therapies. As the intervention is currently in development, additional details will be provided once development and usability testing phases have been completed.
    Primary Outcome Measure Information:
    Title
    Acceptability of Intervention Measure (AIM)
    Description
    Questionnaire assessing healthcare provider perspectives on acceptability of the intervention. Total score ranges from 4-20, with higher scores indicating greater acceptability.
    Time Frame
    Within 2 weeks post-intervention
    Title
    Patient/Caregiver Satisfaction Questionnaire
    Description
    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.
    Time Frame
    Within 2 weeks post-intervention
    Title
    Feasibility of Intervention Measure (FIM)
    Description
    Questionnaire assessing healthcare provider perspectives on the feasibility of the intervention. Total score ranges from 4-20, with higher scores indicating greater feasibility.
    Time Frame
    Within 2 weeks post-intervention
    Title
    Participant Recruitment Rate
    Description
    Rate of participant enrollment and retention in the study
    Time Frame
    Time of enrollment through study completion, approximately 12 months
    Title
    Shared Decision Making Questionnaire (SDM-Q-9)
    Description
    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.
    Time Frame
    Within 2 weeks post-intervention
    Title
    Disease-Modifying Therapy Knowledge Questionnaire
    Description
    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.
    Time Frame
    Within 2 weeks post-intervention
    Secondary Outcome Measure Information:
    Title
    Initiation of disease-modifying therapy
    Description
    Proportion of patients who agree to initiate a disease-modifying therapy following use of the shared decision making intervention
    Time Frame
    Within 6 months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours or ChristianaCare 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 and ChristianaCare SCD healthcare providers will also be included. English language fluency is a requirement for all participants. Exclusion Criteria: Patients/ caregivers who previously participated in usability testing of the intervention will be excluded. Patients will also be excluded 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.

    12. IPD Sharing Statement

    Learn more about this trial

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