Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT06853158
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease
Sponsor:
University of California, Irvine
Organization:
Study Overview
Official Title:
MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MULTI-MUSIQOLS
Brief Summary:
This is a multi-site, multi-visit feasibility RCT of music therapy (MT) among adolescent and adult patients (aged 14 and older) with sickle cell disease (SCD).
Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE).
Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule.
The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met.
This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.
Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE).
Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule.
The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met.
This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.
Detailed Description:
The objectives of this study are to (1) conduct a feasibility randomized control trial (RCT), to examine the data collection processes, and intervention (in-person music therapy \[InMT\], hybrid MT \[HybMT\], and hybrid health education \[HybHE\]) implementation overall and across 2 sites (University Hospitals/Case Western Reserve University \[site 1\] and Prisma Health/University of South Carolina \[site 2\]); and (2) evaluate the implementation of the InMT, HybMT, and HybHE interventions using both quantitative data (study records, stakeholder surveys) and qualitative data (interviews).
Three wellbeing programs for individuals with SCD will be compared: (1) InMT, (2) HybMT, and (3) HybHE. Each intervention includes 6 sessions. The treatment period for each group will be 6 to 8 weeks. Each weekly session will last up to one hour in all arms of the study. MT sessions in the InMT and HybMT arms will include the topics of SCD education and MT rationale, breathing exercises, relaxation, imagery, music making, and review and creation of a coping plan for future challenges. The HybHE group will use an adapted version of Project Patients Empowered and Educated Providers (PEEP). Covered topics include: science of SCD, identifying barriers in the Emergency Department, tools for navigating the healthcare system, healthcare based communication, and review and planning for future challenges.
Semi-structured qualitative interview topics will focus on participants' perceptions of the interventions, perceived benefits and burdens of the interventions, and other barriers and facilitators to in-person and hybrid delivery.
Three wellbeing programs for individuals with SCD will be compared: (1) InMT, (2) HybMT, and (3) HybHE. Each intervention includes 6 sessions. The treatment period for each group will be 6 to 8 weeks. Each weekly session will last up to one hour in all arms of the study. MT sessions in the InMT and HybMT arms will include the topics of SCD education and MT rationale, breathing exercises, relaxation, imagery, music making, and review and creation of a coping plan for future challenges. The HybHE group will use an adapted version of Project Patients Empowered and Educated Providers (PEEP). Covered topics include: science of SCD, identifying barriers in the Emergency Department, tools for navigating the healthcare system, healthcare based communication, and review and planning for future challenges.
Semi-structured qualitative interview topics will focus on participants' perceptions of the interventions, perceived benefits and burdens of the interventions, and other barriers and facilitators to in-person and hybrid delivery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 7R01AT012508-02 | NIH | None | https://reporter.nih.gov/quic… | View |