Clinical trial NCT03233269: BEATS 2: Music Therapy in Sickle Cell
Official title: BEATS 2: The Effects of Music Therapy on Young Adults With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Kulas Foundation
First posted: 2017-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[IRB# 03-15-30\]?


Eligibility criteria: Inclusion Criteria:

* Subject is between 18 and 35 years of age
* Subject is diagnosed with sickle cell disease
* Subject is able to speak and understand English
* Subject has a working email address.
* Subject has access to a mobile device with email capabilities.

Exclusion Criteria:

* Subject has significant hearing impairment that has not been corrected
* Subject has significant visual impairment that has not been corrected

Primary outcomes:
measure: Change from baseline in scores on the Sickle Cell Self-Efficacy Scale (SCSES)
timeFrame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
measure: Change from baseline in scores on the Wake Forest Trust in the Medical Profession Scale
timeFrame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
measure: Change from baseline in scores on the Seidman Sickle Cell Knowledge Quiz
timeFrame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
Secondary outcomes:
measure: Change from baseline in rate of adherence to clinic appointments during the one-year study period.
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals
name: Samuel N Rodgers-Melnick, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: