Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT04571502
Brief Summary:
Alzheimer's disease and related dementias (ADRD) are leading causes of disability and often result in communication deficits of the person with dementia (PWD) that can complicate ADRD caregiving and clinical care. The research team will work with stakeholders to develop and design a personalized Assistive and Alternative Communication (AAC) device that relies on information technology (IT) and touchscreens to promote communication and personhood for PWD about their care preferences and experiences. This study will integrate the AAC into an existing health IT intervention that already facilitates clinical communication between caregivers and providers of PWD. A clinical trial will be conducted to evaluate outcomes of 58 dyads (PWD/caregivers) and their health care provider utilizing the My PATI (My Person Assisted Touchscreen Interface)intervention as an adjunct to care and care giving for 6 months.
Detailed Description:
The target enrollment for the clinical trial is 58 dyads of caregivers and people with dementia (PWD), where 58 unique dyads of caregivers/PWD will participate. The team plans to enroll a total of 58 dyads across two participating clinical sites. Participants will be randomly assigned to either the full intervention or a control condition for a period of 6 months, where they will be asked to communicate clinical and other relevant information with one another as part of regular caregiving and clinical care activities. Several psychosocial outcome variables for providers, caregivers, and PWD will be assessed. We will compare outcomes based on group assignment and different amounts and patterns of use of the MyPATI (e.g., minimal/non-users versus frequent users). The primary outcome variables are quality of life for caregivers and PWD. The research team will recruit an estimated 15 healthcare providers across both sites at the end of study to assess their experience with My PATI using open and closed ended queries.
Study:
NCT04571502
Study Brief:
Protocol Section:
NCT04571502