Sickle Cell DiseaseNCT03233269
BEATS 2: Music Therapy in Sickle Cell
A study testing Music Therapy in people with Sickle Cell Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Subject has significant hearing impairment that has not been corrected
- Subject has significant visual impairment that has not been corrected
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: BEATS 2: The Effects of Music Therapy on Young Adults With Sickle Cell Disease
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:
Read more
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]?
- Conditions
- Sickle Cell Disease
- Being tested
- Music Therapy
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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 via a prerecorded video. The Music Therapist will then engage the patients 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 group | Role | What they receive |
|---|---|---|
| Music Therapy Group | Experimental | 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). Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in scores on the Sickle Cell Self-Efficacy Scale (SCSES)
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.
Measured: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
Change from baseline in scores on the Wake Forest Trust in the Medical Profession Scale
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.
Measured: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
Change from baseline in scores on the Seidman Sickle Cell Knowledge Quiz
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).
Measured: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
Secondary outcomes (1)
Change from baseline in rate of adherence to clinic appointments during the one-year study period.
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
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start26 Jun 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kulas Foundation
- Responsible party
- Principal investigator, Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
- Investigators
- Samuel N Rodgers-Melnick, MT-BC, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233269
- Sponsor's protocol ID
- 06-17-07
- Status last verified
- Oct 2018
- First submitted
- 25 Jul 2017
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEATS 2: The Effects of Music Therapy on Young Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03233269
- Acronym / sponsor ID
- 06-17-07
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Kulas Foundation
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Group | Experimental | Behavioral: Music TherapyMusic 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject has significant hearing impairment that has not been corrected
- Subject has significant visual impairment that has not been corrected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyDuring 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 via a prerecorded video. The Music Therapist will then engage the patients 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. | Behavioural | Music Therapy Group |
Primary outcome
Change from baseline in scores on the Sickle Cell Self-Efficacy Scale (SCSES)
Time frame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
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, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
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, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.
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).
1 secondary outcome
Change from baseline in rate of adherence to clinic appointments during the one-year study period.
Time frame: Baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Website for music therapy program at UH Seidman Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel N Rodgers-Melnick, MT-BC principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Sickle Cell Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in scores on the Sickle Cell Self-Efficacy Scale (SCSES) (time frame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.