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Ambient Independence Measures for Guiding Care Transitions

Ambient Independence Measures for Guiding Care Transitions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02566239
Acronym
AIMs
Enrollment
96
Registered
2015-10-02
Start date
2014-03-31
Completion date
2019-08-12
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

aging, ORCATECH, Oregon Center for Aging & Technology, Life Lab, Living Lab, in-home assessment, technology and aging

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.

Interventions

OTHERShare activity data with care team

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Increased Need for Assistance During 3-year Study Period3 yearsSelf-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

Countries

United States

Participant flow

Pre-assignment details

Ninety-six participants were enrolled and signed consent however five withdrew before randomization and data collection began.

Participants by arm

ArmCount
Shared Data
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.
43
Non-shared Data
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.
48
Total91

Baseline characteristics

CharacteristicShared DataNon-shared DataTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
43 Participants48 Participants91 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous86.4 years
STANDARD_DEVIATION 7
86.2 years
STANDARD_DEVIATION 7
86.3 years
STANDARD_DEVIATION 7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
41 Participants47 Participants88 Participants
Sex: Female, Male
Female
38 Participants34 Participants72 Participants
Sex: Female, Male
Male
5 Participants14 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 437 / 48
other
Total, other adverse events
0 / 430 / 48
serious
Total, serious adverse events
0 / 430 / 48

Outcome results

Primary

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

Time frame: 3 years

Population: Ninety-one participants were enrolled and randomized.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Shared DataNumber of Participants With Increased Need for Assistance During 3-year Study Period13 Participants
Non-shared DataNumber of Participants With Increased Need for Assistance During 3-year Study Period16 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026