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

NCT04571502 | Enrolling By Invitation DMC

• 2 other identifiers: R01AG068572NIH Award R01AG068572
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Neurocognitive Disorders; Alzheimer Disease; Caregiver

Keywords

Health technology; Assistive and Alternative Communication Device; Family Centered Care; Personhood

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Life In Alzheimer's disease- Care Recipient and Caregiver (proxy-interview)

  The 13-item QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the care recipient's physical health, mood, relationships, activities, and ability to complete tasks. The Care Recipient (self-assesses) and caregiver (proxy-interview) complete the QOL-AD.

  Baseline, 3-months, 6- months

• Change in Perceived Change Index- Caregiver QOL

  A 13-item scale that measures caregiver appraisals of self-improvement or decline in distinct areas of well- being. Caregiver indicates whether each item has become worse, stayed the same, or improved in the past month: feeling rested, ability to have time for yourself, and feelings of being upset. The total and subscales (Affect, Somatic, and Ability to Manage)

  Baseline, 3-months, 6- months

Secondary Outcomes (12)

• Change in PATIENT HEALTH QUESTIONNAIRE (PHQ-9)- Caregiver

  Baseline, 3-months, 6- months

• Change in The Positive Aspects of Caregiving Scale- Caregiver

  Baseline, 3-months, 6- months

• Change in Zarit Caregiver Burden Inventory-22 items (ZBI-22)- Caregiver

  Baseline, 3-months, 6-months

• Change in 12 Item Short-Form Health Survey (SF-12) - Caregiver

  Baseline,6-months

• Change in The Revised Memory and Behavior Problems Checklist - Caregiver interviewed about Care Recipient

  Baseline, 6-months

Study Arms (2)

Full Intervention

EXPERIMENTAL

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.

Other: My PATI ( Person Assisted Touchscreen Interface)

Usual Care

NO INTERVENTION

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

Interventions

My PATI ( Person Assisted Touchscreen Interface) 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.

Full Intervention

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers:
• Regular access to the internet (via computer or smartphone) and telephone
• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• National Institute on Aging (NIA): collaborator
• University of Alabama, Tuscaloosa: collaborator

Study Sites (2)

UAB Alzheimer's Risk Assessment and Intervention Clinic

Birmingham, Alabama, 35233, United States

Location

Miami Jewish Health

Miami, Florida, 33137, United States

Location

Related Publications (14)

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  PMID: 11556941 BACKGROUND

• 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.

  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.

  PMID: 14692875 BACKGROUND

• Brown EL, Ruggiano N, Page TF, Roberts L, Hristidis V, Whiteman KL, Castro J. CareHeroes Web and Android Apps for Dementia Caregivers: A Feasibility Study. Res Gerontol Nurs. 2016 Jul-Aug;9(4):193-203. doi: 10.3928/19404921-20160229-02. Epub 2016 Mar 4.

  PMID: 29977440 BACKGROUND

• 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.

  PMID: 31697393 BACKGROUND

• Ruggiano N, Brown EL, Li J, Scaccianoce M. Rural Dementia Caregivers and Technology: What Is the Evidence? Res Gerontol Nurs. 2018 Jul 1;11(4):216-224. doi: 10.3928/19404921-20180628-04.

  PMID: 30036405 BACKGROUND

• Brown EL, Ruggiano N, Li J, Clarke PJ, Kay ES, Hristidis V. Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. J Appl Gerontol. 2019 Jan;38(1):73-91. doi: 10.1177/0733464817723088. Epub 2017 Aug 4.

  PMID: 28774215 BACKGROUND

• 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.

  PMID: 30422754 BACKGROUND

• 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.

  PMID: 7203086 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 1466831 BACKGROUND

• 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.

  PMID: 3337862 BACKGROUND

• Bayles KA, Tomoeda CK. FLCI: Functional Linguistic Communication Inventory. Canyonlands Publishing, Incorporated; 1994.

  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.

  PMID: 34542347 DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessors will not be involved with the intervention implementation and study participants will be asked not to reveal their group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 1, 2020
• Study Start: February 7, 2025
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)