Clinical trial NCT02466555: Music Therapy in Sickle Cell Transition Study
Official title: The Effects of Music Therapy on Transition Outcomes in Young Adult Patients 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: 2015-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
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 sickle cell disease during transition.

Primary Hypotheses:

Compared to baseline, young adult patients with sickle cell disease who receive the music therapy interventions will report:

1. Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES),
2. Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and
3. Higher sickle cell disease knowledge as measured by the Seidman Sickle Cell Knowledge Quiz.

Secondary Hypotheses

1. Compared to the one year prior to the study period, young adults with sickle cell disease who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period.

Additional Questions

1. Do music therapy interventions influence attendance to scheduled blood transfusions?
2. Do music therapy interventions influence the rate of hospital utilization as measured by Emergency Department visits, Acute Care Clinic visits, and admissions during the study period compared to the previous year?
3. 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?
4. 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?


Eligibility criteria: Inclusion Criteria:

* Subject is between 18 and 23 years of age
* Subject is diagnosed with sickle cell disease
* Subject is able to speak and understand English
* Subject is currently scheduled for quarterly appointments in the Bridge Clinic

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 (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES)
timeFrame: Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported
measure: Change (T1-T5) From Baseline in Scores on the Wake Forest Trust in the Medical Profession Scale
timeFrame: Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported
measure: Change (T1-T5) From Baseline in Scores on the Seidman Sickle Cell Knowledge Quiz
timeFrame: Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported
Secondary outcomes:
measure: Change From Baseline in Percentage of Attended Clinic Appointments During the One-year Study Period.
timeFrame: Baseline (T1), 12 months (T5)
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: