NCT02566239

Brief Summary

The purpose of this study is to learn more about how to maintain health and independence for seniors by developing tools that collect data constantly from their home. Caregivers can then use this information to make decisions about their health care, such as when an individual may not be able to live independently any longer. Specific Aims of this study are:

  • Aim 1: To identify trends in our data that predict health decline. To serve this aim, we want to test a number of tools that we have developed, such as in-home sensors, to determine which ones are best at measuring health risks in seniors. After collecting information for one year, we will look at which tools could be most useful to provide feedback to seniors and their communities about the process of aging.
  • Aim 2: To develop a system for analyzing the data we collect and presenting a summary of the data to care teams.
  • Aim 3: To validate our data and the computer-based tool in senior community settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 4, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

5.5 years

First QC Date

August 14, 2015

Results QC Date

June 22, 2021

Last Update Submit

July 13, 2021

Conditions

Keywords

agingORCATECHOregon Center for Aging & TechnologyLife LabLiving Labin-home assessmenttechnology and aging

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Increased Need for Assistance During 3-year Study Period

    Self-reported endorsement to the question "In the past week, is someone newly assisting you with medication management, bathing, dressing or grooming?" OR permanent move from independent living to assisted living or to a health care center

    3 years

Study Arms (2)

Shared Data

EXPERIMENTAL

Share activity data with care team. Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors.

Other: Share activity data with care team

Non-shared Data

NO INTERVENTION

Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors.

Interventions

Share participant in-home activity data with retirement community care team.

Shared Data

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Live alone
  • Live independently
  • Computer user with internet

You may not qualify if:

  • Dementia (CDR scale score \> 0.5)
  • Medical illness that would limit physical participation (e.g. wheelchair use) or likely to lead to death within three years (e.g. terminal cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (14)

  • Kaye J, Reynolds C, Bowman M, Sharma N, Riley T, Golonka O, Lee J, Quinn C, Beattie Z, Austin J, Seelye A, Wild K, Mattek N. Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data. J Vis Exp. 2018 Jul 27;(137):56942. doi: 10.3791/56942.

    PMID: 30102277BACKGROUND
  • Seelye A, Mattek N, Sharma N, Riley T, Austin J, Wild K, Dodge HH, Lore E, Kaye J. Weekly observations of online survey metadata obtained through home computer use allow for detection of changes in everyday cognition before transition to mild cognitive impairment. Alzheimers Dement. 2018 Feb;14(2):187-194. doi: 10.1016/j.jalz.2017.07.756. Epub 2017 Oct 26.

    PMID: 29107052BACKGROUND
  • Austin J, Hollingshead K, Kaye J. Internet Searches and Their Relationship to Cognitive Function in Older Adults: Cross-Sectional Analysis. J Med Internet Res. 2017 Sep 6;19(9):e307. doi: 10.2196/jmir.7671.

    PMID: 28877864BACKGROUND
  • Seelye A, Mattek N, Sharma N, Witter P, Brenner A, Wild K, Dodge H, Kaye J. Passive Assessment of Routine Driving with Unobtrusive Sensors: A New Approach for Identifying and Monitoring Functional Level in Normal Aging and Mild Cognitive Impairment. J Alzheimers Dis. 2017;59(4):1427-1437. doi: 10.3233/JAD-170116.

    PMID: 28731434BACKGROUND
  • Austin J, Klein K, Mattek N, Kaye J. Variability in medication taking is associated with cognitive performance in nondemented older adults. Alzheimers Dement (Amst). 2017 Mar 6;6:210-213. doi: 10.1016/j.dadm.2017.02.003. eCollection 2017.

    PMID: 28349120BACKGROUND
  • Kaye J. Making Pervasive Computing Technology Pervasive for Health & Wellness in Aging. Public Policy Aging Rep. 2017;27(2):53-61. doi: 10.1093/ppar/prx005. Epub 2017 Jun 9. No abstract available.

    PMID: 31148911BACKGROUND
  • Austin J, Dodge HH, Riley T, Jacobs PG, Thielke S, Kaye J. A Smart-Home System to Unobtrusively and Continuously Assess Loneliness in Older Adults. IEEE J Transl Eng Health Med. 2016 Jun 10;4:2800311. doi: 10.1109/JTEHM.2016.2579638. eCollection 2016.

    PMID: 27574577BACKGROUND
  • Silbert LC, Dodge HH, Lahna D, Promjunyakul NO, Austin D, Mattek N, Erten-Lyons D, Kaye JA. Less Daily Computer Use is Related to Smaller Hippocampal Volumes in Cognitively Intact Elderly. J Alzheimers Dis. 2016;52(2):713-7. doi: 10.3233/JAD-160079.

    PMID: 26967228BACKGROUND
  • Seelye A, Hagler S, Mattek N, Howieson DB, Wild K, Dodge HH, Kaye JA. Computer mouse movement patterns: A potential marker of mild cognitive impairment. Alzheimers Dement (Amst). 2015 Dec 1;1(4):472-480. doi: 10.1016/j.dadm.2015.09.006. Epub 2015 Oct 19.

    PMID: 26878035BACKGROUND
  • Petersen J, Austin D, Mattek N, Kaye J. Time Out-of-Home and Cognitive, Physical, and Emotional Wellbeing of Older Adults: A Longitudinal Mixed Effects Model. PLoS One. 2015 Oct 5;10(10):e0139643. doi: 10.1371/journal.pone.0139643. eCollection 2015.

    PMID: 26437228BACKGROUND
  • Seelye A, Mattek N, Howieson DB, Austin D, Wild K, Dodge HH, Kaye JA. Embedded Online Questionnaire Measures Are Sensitive to Identifying Mild Cognitive Impairment. Alzheimer Dis Assoc Disord. 2016 Apr-Jun;30(2):152-9. doi: 10.1097/WAD.0000000000000100.

    PMID: 26191967BACKGROUND
  • Lyons BE, Austin D, Seelye A, Petersen J, Yeargers J, Riley T, Sharma N, Mattek N, Wild K, Dodge H, Kaye JA. Pervasive Computing Technologies to Continuously Assess Alzheimer's Disease Progression and Intervention Efficacy. Front Aging Neurosci. 2015 Jun 10;7:102. doi: 10.3389/fnagi.2015.00102. eCollection 2015.

    PMID: 26113819BACKGROUND
  • Seelye A, Mattek N, Howieson D, Riley T, Wild K, Kaye J. The impact of sleep on neuropsychological performance in cognitively intact older adults using a novel in-home sensor-based sleep assessment approach. Clin Neuropsychol. 2015;29(1):53-66. doi: 10.1080/13854046.2015.1005139. Epub 2015 Feb 2.

    PMID: 25642948BACKGROUND
  • Wild K, Sharma N, Mattek N, Karlawish J, Riley T, Kaye J. Application of In-Home Monitoring Data to Transition Decisions in Continuing Care Retirement Communities: Usability Study. J Med Internet Res. 2021 Jan 13;23(1):e18806. doi: 10.2196/18806.

Results Point of Contact

Title
Dr. Jeffrey Kaye
Organization
Oregon Health & Science University

Study Officials

  • Jeffrey Kaye, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Layton Endowed Professor of Neurology & Biomedical Engineering, Director of ORCATECH

Study Record Dates

First Submitted

August 14, 2015

First Posted

October 2, 2015

Study Start

March 1, 2014

Primary Completion

August 12, 2019

Study Completion

August 12, 2019

Last Updated

August 4, 2021

Results First Posted

August 4, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations