The goal of this study is to develop an operational concept (OpsCon) and refined device prototype for delivering low frequency, low intensity (LFLI) ultrasound therapy to patients with chronic wounds and Alzheimer's disease or Alzheimer's disease related dementia (AD/ADRD) in a home setting by family caregivers. The number of individuals with AD/ADRD who have chronic wounds such as venous ulcers, diabetic foot ulcers, and pressure ulcers is expected to increase in the older American population. Wound care is reported to be a difficult medical/nursing task for family caregivers of persons with cognitive impairment, and is associated with the challenging behavior of resistiveness to care among people with AD/ADRD. There is an urgent need to address wound care in people with AD/ADRD and develop chronic wound care treatments and protocols that reduce resistiveness to care and expedite healing. We have developed a safe, wearable, battery-operated prototype for delivering low frequency, low intensity therapeutic ultrasound to chronic wounds. The current iteration is being used in a clinical trial (parent grant, 5R01NR015995) in an outpatient clinical setting where it is operated and maintained by trained research personnel. The system's safety profile and potential simplicity of operation and maintenance make it an excellent candidate for use in home settings. However, the system must be redesigned for in-home treatment of AD/ADRD patients with chronic wounds.
The aims of this proposal are to: (1) Develop the operational concept for ultrasound treatment by home caregivers providing chronic wound care to older adults with AD/ADRD.
This aim focuses on specifying the operational concept for using and maintaining the ultrasound treatment in the home. Focus groups with patients, caregivers, homecare nurses, and physicians as well as simulations using the ultrasound prototype will help to define the components of the OpsCon: user description, operational environment, and operation scenarios. (2) Refine the ultrasound prototype for use by AD/ADRD caregivers in the home setting, by addressing device usability and maintenance needs identified during our ongoing clinical trial. Successful completion of this interdisciplinary administrative supplement will enable the design and implementation of a pragmatic clinical trial in homecare settings with people having both AD/ADRD and chronic wounds.
The number of individuals with Alzheimer?s disease and Alzheimer?s disease related dementia (AD/ADRD) who have chronic wounds such as venous ulcers, diabetic foot ulcers, and pressure ulcers is expected to increase in the older American population. Wound care is reported to be the second most difficult medical/nursing task performed by family caregivers of persons with challenging behaviors (including cognitive impairment), and there is need for improved chronic wound therapies for individuals with AD/ADRD. We have developed a wearable low frequency, low intensity ultrasound therapy that is undergoing clinical testing in the setting of a wound clinic; we propose to develop an operational concept and refined ultrasound device prototype that will enable delivery of this therapy to patients with AD/ADRD and chronic wounds and in a home setting by family caregivers.
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