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Clinical Trials/NCT02566239
NCT02566239CompletedNot Applicable

Ambient Independence Measures for Guiding Care Transitions

Oregon Health and Science University2 sites in 1 country96 target enrollmentStarted: March 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
96
Locations
2
Primary Endpoint
Number of Participants With Increased Need for Assistance During 3-year Study Period

Study Overview

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.

Detailed Description

The proposed study has the potential to transform current research and clinical practice paradigms of prediction and decision making about independent living. This is accomplished by shifting from reliance on episodic, self-reported or crisis event provoked data to the use of ecologically valid multidimensional and continuous physiological, activity, and behavioral data. This approach has great potential to substantially improve care need and transition decisions. In achieving this goal several innovations beyond available systems and ongoing research are notable. First, grounded by prior studies associating static clinical measures to future placement outcomes, we now contemporaneously and continuously will acquire fundamental physiological measures (weight and walking speed), activity and behavioral measures, thereby improving our ability to proactively discriminate important health and functional change in real time. Using existing in-home activity data collected longitudinally in an aging population combined with simulated data from additional new sensed measures (phone use, medication taking, body composition) we will generate derived novel metrics - AIMs - to provide objective dynamic measures of activity and behaviors that are essential to maintaining independence. These metrics will be used to develop prediction algorithms based on documented transition outcomes from the original data set to be used by care teams (Aim 1). Working care transition professionals will be iteratively queried for the refinement of these objective measures (Aim 2). These care providers' expertise and understanding of key changes that impact independence is invaluable to identification of ambient independence measures that matter, and lead to meaningful care implementation pathways. The efficacy of the final set of measures chosen and built into a user friendly interface for the care team to use (Aim 2) will then be tested (Aim 3) by comparing independently living seniors in one of three comparison groups: 1) installed technology, from which AIMs data will be extracted and provided to the care transition team to aid in transition decisions; 2) installed technology, from which AIMs data will be extracted but will not be available to the transition team; and 3) no technology. We may have insufficient power to recognize significant change between the validation group and the control group. However, this primarily study is intended to test the feasibility of the approach, and to identify those types of AIMs data that are most useful for making transition decisions, which will be used to inform larger, more definitive studies in the future.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Live alone
  • Live independently
  • Computer user with internet

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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

Time Frame: 3 years

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Kaye

Layton Endowed Professor of Neurology & Biomedical Engineering, Director of ORCATECH

Oregon Health and Science University

Study Sites (2)

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