Overview

This trial is active, not recruiting.

Condition aging
Treatment share activity data with care team
Sponsor Oregon Health and Science University
Collaborator National Institute on Aging (NIA)
Start date March 2014
End date June 2018
Trial size 96 participants
Trial identifier NCT02566239, 5R01AG042191-03, OHSU9944

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(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.
share activity data with care team
Share participant in-home activity data with retirement community care team.
(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.

Primary Outcomes

Measure
Self-Reported Activities of Daily Living (ADL) Assistance
time frame: 3 years

Secondary Outcomes

Measure
Transfers to Higher Level of Care
time frame: 3 years
Incidence of Adverse Events
time frame: 3 years
Additional Resident Assistance
time frame: 3 years

Eligibility Criteria

Male or female participants at least 70 years old.

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)

Additional Information

Official title Ambient Independence Measures for Guiding Care Transitions
Principal investigator Jeffrey Kaye, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.