Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care

Обзор

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.

Вмешательства

• Поведенческое Music therapy
  Live 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.

Первичные конечные точки

• Delirium scores [Срок оценки: every 24 hours until discharge (on average 7 days)]
• Number of music therapy sessions successfully completed [Срок оценки: during hospitalization, on average 7 days]

Вторичные конечные точки (4)

• Number of days that participants screen CAM-positive [Срок оценки: during hospitalization, on average 7 days]
• Number of participants given antipsychotic medications [Срок оценки: during hospitalization, on average 7 days]
• Number of participants requiring physical restraints [Срок оценки: during hospitalization, on average 7 days]
• Number of participants with one-to-one sitter orders [Срок оценки: during hospitalization, on average 7 days]

Критерии участия

Критерии включения

• Admitted as inpatient to Boston Medical Center.
• Cognitive impairment or neurodegenerative diseases as defined by either:

• 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
• Participants with cognitive impairment will be included. If unable to consent, legally authorized representative (LAR) based on HRP-013-SOP-LARs, Children, and Guardians will be contacted to consent.
• Spanish speaking participants will be included. Screening and informed consent procedures will be conducted using a certified medical interpreter. All intervention sessions and study team interactions will be conducted using these interpreter services.
• Patients admitted to an intensive care unit will be included as long as they are not receiving continuous intravenous sedative medications. Potential participants in the intensive care unit setting will be discussed with a PI/co-I to ensure participation is appropriate on a case-by-case basis. The PI/Co-I will confirm with the treating physician that there are no reasons as to why the potential participant should not be enrolled in the study.

Критерии исключения

• 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)
• Dislike of music: Barcelona Music Reward Questionnaire score of <40
• Patients who are currently prisoners
• Patients in the intensive care unit receiving continuous intravenous sedative medication
• Pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Boston Medical Center — Boston

Идентификаторы

NCT: NCT07137949 · H-46190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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