We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Music Therapy in Sickle Cell Transition Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02466555
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Kulas Foundation
Information provided by (Responsible Party):
Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE June 4, 2015
First Posted Date  ICMJE June 9, 2015
Results First Submitted Date  ICMJE November 1, 2018
Results First Posted Date  ICMJE September 13, 2019
Last Update Posted Date September 13, 2019
Study Start Date  ICMJE June 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Change (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES) [ Time Frame: 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.
  • Change (T1-T5) From Baseline in Scores on the Wake Forest Trust in the Medical Profession Scale [ Time Frame: 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 Seidman Sickle Cell Knowledge Quiz [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Change from baseline in scores on the Sickle Cell Self-Efficacy Scale (SCSES) [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
    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.
  • Change from baseline in scores on the Wake Forest Trust in the Medical Profession Scale [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
    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 from baseline in scores on the Seidman Sickle Cell Knowledge Quiz [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
    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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)		 Change From Baseline in Percentage of Attended Clinic Appointments During the One-year Study Period. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2015)		 Change from baseline in rate of adherence to clinic appointments during the one-year study period. [ Time Frame: Baseline, 12 months ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Music Therapy in Sickle Cell Transition Study
Official Title  ICMJE The Effects of Music Therapy on Transition Outcomes in Young Adult Patients With Sickle Cell Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Behavioral: Music Therapy
During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.
Study Arms  ICMJE Experimental: Music Therapy Group
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).
Intervention: Behavioral: Music Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2015)		 30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 23 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02466555
Other Study ID Numbers  ICMJE 03-15-30
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Kulas Foundation
Investigators  ICMJE
Principal Investigator: Samuel N Rodgers-Melnick, MT-BC University Hospitals
PRS Account University Hospitals Cleveland Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP