Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care

NCT ID: NCT04571502

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-07

Study Completion Date

2026-01-06

Brief Summary

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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

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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.

Conditions

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Neurocognitive Disorders Alzheimer Disease Caregiver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Outcome Assessors will not be involved with the intervention implementation and study participants will be asked not to reveal their group assignment.

Study Groups

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Full Intervention

Dyads (caregiver, PWD) randomly assigned to the experimental arm will have access to the newly developed My PATI app. Providers' will receive information via the app.

Group Type EXPERIMENTAL

My PATI ( Person Assisted Touchscreen Interface)

Intervention Type OTHER

My PATI was designed to support communication between PWD and their caregiver, and healthcare provide; promotes person centered care by giving the PWD their voice and specifically by supporting the PWD in expressing their experiences , needs, preferences in care activities (e.g., food choices, clothing), and entertainment ( personalized pictures, videos , and music). My PATI has multiple features including allowing the caregiver to assess symptoms of the PWD using clinical assessments, which can be shared with the healthcare provider. The clinical trial evaluates the impact of the My PATI interface that relies on touchscreen technology ( two interfaces one for PWD that can be used independently or with assistance, and a 2nd caregiver interface for customization ). The comparison group will receive usual care.

Usual Care

Dyads (caregiver, PWD) randomly assigned to the usual care condition will receive usual care from the memory clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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My PATI ( Person Assisted Touchscreen Interface)

My PATI was designed to support communication between PWD and their caregiver, and healthcare provide; promotes person centered care by giving the PWD their voice and specifically by supporting the PWD in expressing their experiences , needs, preferences in care activities (e.g., food choices, clothing), and entertainment ( personalized pictures, videos , and music). My PATI has multiple features including allowing the caregiver to assess symptoms of the PWD using clinical assessments, which can be shared with the healthcare provider. The clinical trial evaluates the impact of the My PATI interface that relies on touchscreen technology ( two interfaces one for PWD that can be used independently or with assistance, and a 2nd caregiver interface for customization ). The comparison group will receive usual care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Caregivers:

* Regular access to the internet (via computer or smartphone) and telephone
* 21 years-old or older
* Providing caregiving activities (Activities of Daily Living and/or Instrumental Activities of Daily Living) for an average of 2 hours or more per day of direct assistance or supervision for a person with ADRD
* Speak and understand English or Spanish.

Care Recipient:

* 60 years or older
* Speak and understand English or Spanish
* Have an established diagnosis of a Neurocognitive Disorder (Alzheimer's disease, vascular dementia, frontotemporal dementia, Lewy body dementia or Parkinson's disease dementia)
* Receive a score on the Mini Mental Status Exam of less than 24
* Be able to complete the eligibility vision screen.

Healthcare Providers:

\* Provide ongoing healthcare and support services to PWD and their families.

Exclusion Criteria

Caregivers:

* Provide care to a PWD living in an assisted living facility or nursing home
* Plan for the PWD to be placed in a long-term care facility during the study period
* Plan to end their role as caregiver within 6 months of study enrollment
* Have their own major medical conditions affecting independent functioning (e.g. illness or disability) or cognitive impairment
* Do not speak and read English or Spanish
* Have known active suicidal ideation

Care Recipients:

* Significant visual or hearing impairment (with supports)
* Known active suicidal ideation
* Schizophrenia diagnosis
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Alabama, Tuscaloosa

OTHER

Sponsor Role collaborator

Florida International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UAB Alzheimer's Risk Assessment and Intervention Clinic

Birmingham, Alabama, United States

Site Status

Miami Jewish Health

Miami, Florida, United States

Site Status

Countries

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United States

References

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Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

Tarlow BJ, Wisniewskil SR, Belle SH., et al. Positive Aspects of Caregiving: Contributions of the REACH Project to the Development of New Measures for Alzheimer's Caregiving. 2004; 26(4):429-53.

Reference Type BACKGROUND

Roth DL, Burgio LD, Gitlin LN, Gallagher-Thompson D, Coon DW, Belle SH, Stevens AB, Burns R. Psychometric analysis of the Revised Memory and Behavior Problems Checklist: factor structure of occurrence and reaction ratings. Psychol Aging. 2003 Dec;18(4):906-15. doi: 10.1037/0882-7974.18.4.906.

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Reference Type BACKGROUND
PMID: 29977440 (View on PubMed)

Brown EL, Agronin ME, Stein JR. Interventions to Enhance Empathy and Person-Centered Care for Individuals With Dementia: A Systematic Review. Res Gerontol Nurs. 2020 May 1;13(3):158-168. doi: 10.3928/19404921-20191028-01. Epub 2019 Nov 11.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Ruggiano N, Brown EL, Shaw S, Geldmacher D, Clarke P, Hristidis V, Bertram J. The Potential of Information Technology to Navigate Caregiving Systems: Perspectives from Dementia Caregivers. J Gerontol Soc Work. 2019 May-Jun;62(4):432-450. doi: 10.1080/01634372.2018.1546786. Epub 2018 Nov 13.

Reference Type BACKGROUND
PMID: 30422754 (View on PubMed)

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

Reference Type BACKGROUND
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Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

Reference Type BACKGROUND
PMID: 8628042 (View on PubMed)

Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral problems in dementia: the revised memory and behavior problems checklist. Psychol Aging. 1992 Dec;7(4):622-31. doi: 10.1037//0882-7974.7.4.622.

Reference Type BACKGROUND
PMID: 1466831 (View on PubMed)

Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.

Reference Type BACKGROUND
PMID: 3337862 (View on PubMed)

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Reference Type BACKGROUND

Brown EL, Ruggiano N, Roberts L, Clarke PJ, Davis DL, Agronin M, Geldmacher DS, Hough MS, Munoz MTH, Framil CV, Yang X. Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care: Intervention Trial. Res Gerontol Nurs. 2021 Sep-Oct;14(5):225-234. doi: 10.3928/19404921-20210825-02. Epub 2021 Sep 1.

Reference Type DERIVED
PMID: 34542347 (View on PubMed)

Other Identifiers

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NIH Award R01AG068572

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R01AG068572

Identifier Type: NIH

Identifier Source: org_study_id

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