Music Therapy in Sickle Cell Transition Study

Not Applicable

Completed

Conditions: Sickle Cell Disease

Interventions: Behavioral: Music Therapy

Registration Number: NCT02466555

Lead Sponsor: University Hospitals Cleveland Medical Center

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?

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Music Therapy Group	Music Therapy	Music therapy is the clinical and evidence-based use of music interventions to accomplish individualized goals within a therapeutic relationship by a credentialed professional who has completed an approved music therapy program. Music therapy is an established health profession in which music is used within a therapeutic relationship to address physical, emotional, cognitive, and social needs of individuals (American Music Therapy Association \[AMTA\], 2013, para 1 and 2).

Primary Outcome Measures

Name	Time	Method
Change (T1-T5) From Baseline in Scores on the Seidman Sickle Cell Knowledge Quiz	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	Sickle Cell Disease knowledge will be measured using the Seidman Sickle Cell Knowledge Quiz developed specifically for this study. The Seidman Sickle Cell Knowledge Quiz is adapted from questions from the Sickle Cell Disease Knowledge Test (Kaslow et al., 2000) and How Much Do I Know About Sickle Cell Disease (Baskin, Collins, Kaslow, \& Hsu, 2002). The total score is reported with a minimum score of 0 and a maximum score of 12. Higher scores represent greater knowledge of sickle cell disease.
Change (T1-T5) From Baseline in Scores on the Wake Forest Trust in the Medical Profession Scale	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	Patient trust is the optimistic acceptance of a vulnerable situation in which the patient believes the health-care provider will take care of the patient's interests (Dugan, Trachtenberg, \& Hall, 2005).The Wake Forest Trust in the Medical Profession Scale is a five-item scale in which respondents express their level of agreement with the following statements: 1) Sometimes doctors care more about what is convenient for them than about their patients' medical needs (reverse coded); 2) Doctors are extremely thorough and careful; 3) You completely trust doctors' decisions about which medical treatments are best; 4) A doctor would never mislead you about anything; 5) All in all, you trust your doctor completely. Responses are summed and scores are on a 5-25 scale, with higher values indicating greater trust.
Change (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES)	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	Self-efficacy is the conviction that one can successfully execute the behavior required to produce the outcome. (Bandura, 1997, p. 193). The SCSES is a nine-item Likert scale originally developed for adults with sickle cell disease (Edwards, Telfair, Cecil, \& Lenoci, 2000) and revised in a follow up study by Clay and Telfair (2007) for adolescents using a sample of 131 individuals age 11-19. The total score is reported with a minimum score of 9 and a maximum score of 45. Higher scores represent higher/better self-efficacy.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Percentage of Attended Clinic Appointments During the One-year Study Period.	Baseline (T1), 12 months (T5)	Adherence is the extent to which a person's behavior coincides with medical or prescribed health advice (Julius, 2009). Adherence will be measured regularly throughout the study via medical record review. In order to assess adherence, the following data will be obtained from the medical record on each patient throughout the study period: 1) Total scheduled clinic visits with Adult Sickle Cell Disease Clinic, 2) Number of missed clinic visits to Adult Sickle Cell Disease Clinic due to no show, cancellation, or rescheduling. Adherence to clinic appointments is calculated as total number of attended clinic visits divided by total number of scheduled clinic visits (including no shows) multiplied by 100. The reported adherence percentage is the difference between percentage of visits attended during the 12 months study period minus the percentage of visits attended during the 12 months before the study period.