Clinical trial NCT04571502: Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care
Official title: Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurocognitive Disorders
Alzheimer Disease
Caregiver
Keywords: Health technology
Assistive and Alternative Communication Device
Family Centered Care
Personhood
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Alabama, Tuscaloosa
First posted: 2020-10-01
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life In Alzheimer's disease- Care Recipient and Caregiver (proxy-interview)
timeFrame: Baseline, 3-months, 6- months
measure: Change in Perceived Change Index- Caregiver QOL
timeFrame: Baseline, 3-months, 6- months
Secondary outcomes:
measure: Change in PATIENT HEALTH QUESTIONNAIRE (PHQ-9)- Caregiver
timeFrame: Baseline, 3-months, 6- months
measure: Change in The Positive Aspects of Caregiving Scale- Caregiver
timeFrame: Baseline, 3-months, 6- months
measure: Change in Zarit Caregiver Burden Inventory-22 items (ZBI-22)- Caregiver
timeFrame: Baseline, 3-months, 6-months
measure: Change in 12 Item Short-Form Health Survey (SF-12) - Caregiver
timeFrame: Baseline,6-months
measure: Change in The Revised Memory and Behavior Problems Checklist - Caregiver interviewed about Care Recipient
timeFrame: Baseline, 6-months
measure: Change in Oberved PHQ-9 Caregiver Interviewed about Care Recipient
timeFrame: Baseline, 6-months
measure: Change in Geriatric Depression Scale (GDS-15)- Care Recipient
timeFrame: Baseline, 6-months
measure: Change in Partner-Patient Questionnaire for Shared Activities-Caregiver interviewed about relationship with Care Recipient
timeFrame: Baseline, 3 Months, 6 Months
measure: Change in Functional Linguistic Communication Inventory (FLCI)- Care Recipient
timeFrame: Baseline
measure: My PATI Usage - Links clicked on the app, resources accessed
timeFrame: 6 months
measure: Provider Interviews
timeFrame: 6 months
measure: My PATI Usage- Links clicked on the app, resources accessed
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Alzheimer's Risk Assessment and Intervention Clinic
state: Alabama
city: Miami
country: United States
facility: Miami Jewish Health
state: Florida
Study officials:
References:
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bayles KA, Tomoeda CK. FLCI: Functional Linguistic Communication Inventory. Canyonlands Publishing, Incorporated; 1994.
citation: 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.