Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care
ConditionDelirium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorBoston Medical Center
About this trial
In this pilot study a new kind of music therapy will be created and tested to help prevent confusion, called delirium, that can happen in the hospital. This can affect people with brain diseases like Alzheimer's disease and Parkinson's disease.
Each of the anticipated 30 participants will have up to five music therapy sessions. The sessions will be made just for them and may include live music, playing instruments, or listening to recorded music. Surveys will be used to learn how easy the therapy is to do in the hospital and what people think about how helpful the sessions may be for future patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted as inpatient to Boston Medical Center.
Diagnosis of Parkinson's Disease, Dementia with Lewy Bodies (ICD-10 G20 and G31.83 respectively), Alzheimer's Disease-related dementias (ICD-10 6D80), vascular dementia (F01), or other cognitive impairment (R41) on active problem list or past medical history
"Cognitive impairment" on active problem list or past medical history
Documentation elsewhere in the electronic medical record (e.g. notes) of any of these conditions
Disqualifiers
Admitted to observation status (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)
Patients who will be discharged within 24 hours of eligibility based on discussion with primary admitting team
Self-reported history of musicogenic seizures
Hearing loss: unable to hear a recorded sound <70 decibels (dB)
Trial design
Design model
Single group
Treatments tested in this trial
Music therapy
BehavioralLive music therapy (MT) sessions will occur 3 times/week, up to 5 sessions. Sessions will be responsive to patient preferences, culture, and identity using information gained from medical record review, intake assessment, and in the moment therapeutic assessments.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Music therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Delirium scores
The 3-Minute Diagnostic Interview for the Confusion Assessment Method (3D-CAM) will be used to assess presence and severity of delirium. For participants who cannot complete the 3D-CAM due to non-verbal status, the CAM-ICU will be used in its place.
Time frame
every 24 hours until discharge (on average 7 days)2
Number of music therapy sessions successfully completed
Based on data from study records.
Time frame
during hospitalization, on average 7 daysSecondary outcomes
1
Number of days that participants screen CAM-positive
The 3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM) will be used to assess delirium. It will provide a binary outcome: delirium present (CAM positive) or absent (CAM negative).
Time frame
during hospitalization, on average 7 days2
Number of participants given antipsychotic medications
Based on data from the electronic medical record.
Time frame
during hospitalization, on average 7 days3
Number of participants requiring physical restraints
Based on data from the electronic medical record.
Time frame
during hospitalization, on average 7 days4
Number of participants with one-to-one sitter orders
Based on data from the electronic medical record.
Time frame
during hospitalization, on average 7 daysSponsors and contacts
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Source ClinicalTrials.gov