Prototype Development for Enhanced Ultrasound Treatment by Caregivers of Patients with Alzheimer’s Disease or Related Dementia in the Home Setting

  • STATUS
    Recruiting
  • days left to enroll
    23
Updated on 25 July 2022
Investigator
Zach Hathaway
Primary Contact
Drexel University (online study) Contact
Online studies
Accepts healthy volunteers

Summary

We are conducting this voluntary research study to build the operational concept for a device that will test low-intensity ultrasound as a treatment for chronic wounds in the homecare setting. During the study participants will be asked to participate in a focus group or individual interview to help us understand the challenges associated with providing wound care in a homecare setting and how people will interact with and use the device in a homecare setting, with individuals who have Alzheimer’s disease or related dementia. With permission these sessions may be recorded, and we expect participation in a single interview/focus group to last 60-90 minutes.

Description

We are conducting this voluntary research study to build the operational concept for a device that will test low-intensity ultrasound as a treatment for chronic wounds in the homecare setting. During the study participants will be asked to participate in a focus group or individual interview to help us understand the challenges associated with providing wound care in a homecare setting and how people will interact with and use the device in a homecare setting, with individuals who have Alzheimer’s disease or related dementia. With permission these sessions may be recorded, and we expect participation in a single interview/focus group to last 60-90 minutes. We do not anticipate any direct benefits for participating in this study; however, we believe this research may lead to a safe and effective treatment for individuals with Alzheimer’s disease or related dementia and chronic wounds. The risks of participating are minimal, and include potential loss of privacy. Every effort will be taken to protect participants' information. Participants may feel uncomfortable sharing certain information in a group setting, but are not obligated to share any information that makes them uncomfortable. Participants may choose not to participate, or may leave the study at any time.

Details
Condition Alzheimer’s disease, Lewy Body Dementia, Vascular contributions to cognitive impairment and dementia, Mixed etiology dementias, Chronic wounds, Frontotemporal degeneration
Clinical Study IdentifierTX302915
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Family caregivers of individuals with a documented history of AD/ADRD and a chronic leg wound (currently or within the past 3 years). AD/ADRD includes diagnoses of Alzheimer’s disease, Frontotemporal degeneration, Lewy body dementia, Vascular contributions to cognitive impairment and dementia, and Mixed etiology dementias
OR Homecare nurses with AD/ADRD expertise, and wound care expertise

Exclusion Criteria

Adults unable to consent
Individuals who are not yet adults
Individuals who are prisoners
Individuals unable to read, write, or speak English
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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