Trial Outcomes & Findings for Ambient Independence Measures for Guiding Care Transitions (NCT NCT02566239)

Last Updated: 2021-08-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

3 years

Results posted on

2021-08-04

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	43	48
Overall Study COMPLETED	39	44
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ambient Independence Measures for Guiding Care Transitions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shared Data n=43 Participants 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.	Non-shared Data n=48 Participants 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.	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Age, Continuous	86.4 years STANDARD_DEVIATION 7.0 • n=5 Participants	86.2 years STANDARD_DEVIATION 7.0 • n=7 Participants	86.3 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	47 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Ninety-one participants were enrolled and randomized.

Outcome measures

Outcome measures
Measure	Shared Data n=43 Participants 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.	Non-shared Data n=48 Participants 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.
Number of Participants With Increased Need for Assistance During 3-year Study Period	13 Participants	16 Participants

Adverse Events

Shared Data

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Non-shared Data

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Kaye

Oregon Health & Science University

Phone: 503 494 6695

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place