Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-30 @ 10:23 PM
Study NCT ID:
NCT03233269
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEATS 2: Music Therapy in Sickle Cell
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
BEATS 2: The Effects of Music Therapy on Young Adults With Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2018-10
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:
None
Brief Summary:
The purpose of this study is to investigate the effects of the BEATS music therapy program on the self-efficacy, trust, knowledge, and adherence of young adult patients with SCD.
Primary Hypotheses:
Compared to baseline, young adult patients with SCD who receive the music therapy interventions will report:
Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES), Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and Higher SCD knowledge as measured by the Seidman Sickle Cell Knowledge Quiz.
Secondary Hypotheses Compared to the one year prior to the study period, young adults with SCD who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period.
Additional Questions Do music therapy interventions influence the rate of hospital utilization as measured by ED visits, Acute Care Clinic (ACC) visits, and admissions during the study period compared to the previous year? Do music therapy interventions influence adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the study period? Do music therapy interventions influence adherence to iron chelation therapy for patients receiving iron chelation therapy as measured by ferritin count during the study period? Does the schedule of music therapy interventions in this study improve outcomes more significantly than the schedule of music therapy interventions from \[IRB# 03-15-30\]?
Primary Hypotheses:
Compared to baseline, young adult patients with SCD who receive the music therapy interventions will report:
Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES), Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and Higher SCD knowledge as measured by the Seidman Sickle Cell Knowledge Quiz.
Secondary Hypotheses Compared to the one year prior to the study period, young adults with SCD who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period.
Additional Questions Do music therapy interventions influence the rate of hospital utilization as measured by ED visits, Acute Care Clinic (ACC) visits, and admissions during the study period compared to the previous year? Do music therapy interventions influence adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the study period? Do music therapy interventions influence adherence to iron chelation therapy for patients receiving iron chelation therapy as measured by ferritin count during the study period? Does the schedule of music therapy interventions in this study improve outcomes more significantly than the schedule of music therapy interventions from \[IRB# 03-15-30\]?
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: