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ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)

Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05240534
Enrollment
502
Registered
2022-02-15
Start date
2022-04-29
Completion date
2025-12-03
Last updated
2026-06-17

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

Conditions

Chronic Conditions, Multiple

Keywords

Voice-activated "smart" technology, Older adults

Brief summary

Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills. Patients often struggle with treatment adherence and the emotional and physical burdens of self-management and health tracking. Chronic conditions reduce quality of life (QOL) and increase loneliness, which exacerbate those conditions. The primary purpose of this study is to investigate whether a voice-based platform is better for delivering an electronic health intervention to older adults than a text/typing-based platform. We have an evidence-based electronic health intervention (Elder Tree, ET) that has been shown to improve quality of life, physical and socio-emotional health outcomes for older adults with multiple chronic conditions when delivered via a text/typing-based system. The current project would test whether such patients would benefit even more if ET were delivered via a voice-based system (vs. the text-based system) because they would use it more consistently. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.

Interventions

BEHAVIORALET-Text (Laptop)

ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Text arm will access ET on Laptop.

BEHAVIORALET-Voice (Smart System)

ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Voice arm will access ET on a smart speaker. Voice-activated devices can potentially be easy to use, even by those with limited dexterity or computer experience.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Be ≥60 years old; * Have medical record diagnoses of at least 5 chronic conditions of which at least 3 must come from the following: hypertension, hyperlipidemia, obesity, prediabetes or diabetes, or depression; * Be willing to share medical record data about healthcare use (30-day hospital readmissions and ER, urgent care, primary care, and specialty care visits); * Allow researchers to share information with the patient's primary care provider

Exclusion criteria

* Require an interpreter * Report no current psychotic disorder that would prevent participation * Have no acute medical problem requiring immediate hospitalization * Not report impairments preventing use of a computer or tablet (e.g. blind, deaf)

Design outcomes

Primary

MeasureTime frameDescription
Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of overall health and level of physical disability. There are 4 questions with a possible score of 4-16. Lower scores indicate worse outcomes.
Change in pain interference as assessed by the PROMIS-29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.
Change in pain intensity as assessed by the PROMIS-29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.
Change in fatigue as assessed by the PROMIS-29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.
Change in sleep as assessed by the PROMIS-29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.
Change in anxiety as assessed by the PROMIS-29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.
Change in depression as assessed by the PROMIS-29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.
Change in social roles as assessed by the PROMIS-29 v2.1Baseline, 6, 12, 18 monthsParticipant reported measure of satisfaction with participation in social roles, there are 4 questions, with a possible score of 4-20. Lower scores indicate worse outcomes.

Secondary

MeasureTime frameDescription
Change in overall ElderTree use across the 12-month interventionup to 12 monthsAmount of ElderTree use will be calculated by number of logons in the ET portal.
Change in Physical Function as assessed by PROMIS-43Baseline, 6, 12, 18 monthsParticipant reported measure of overall health and level of physical disability. There are 6 questions with a possible score of 6-30. Lower scores indicate worse outcomes.
Change in Pain Interference as assessed by PROMIS-43Baseline, 6, 12, 18 monthsParticipant reported measure of overall health and level of physical disability. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.
Change in Fatigue as assessed by PROMIS-43Baseline, 6, 12, 18 monthsParticipant reported measure of fatigue. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.
Change in Sleep Disturbance as assessed by PROMIS-43Baseline, 6, 12, 18 monthsParticipant reported measure of sleep disturbance. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.
Change in Anxiety as assessed by PROMIS-43Baseline, 6, 12, 18 monthsParticipant reported measure of anxiety. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.
Change in Depression as assessed by PROMIS-43Baseline, 6, 12, 18 monthsParticipant reported measure of depression. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.
Change in Social Roles as assessed by PROMIS-43Baseline, 6, 12, 18 monthsParticipant reported measure of satisfaction with participation in social roles. There are 6 questions with a possible score of 6-30. Lower scores indicate worse outcomes.
Change in Lorig Health Distress Scale ScoreBaseline, 6, 12, 18 monthsLorig Health Distress Scale is a self-reported measure. It has questions about how participant feel and how things have been during the past month. It is a 4 item scale. Each item can be score from 0-none of the time to 5- all the time. Higher scores corresponds to more amount of time the participant has been distressed about health (e.g.,discouraged, worried, fearful, frustrated by health problems).
Change in NIH Toolbox Loneliness Survey scoresBaseline, 6, 12, 18 monthsNIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness.
Number of Unscheduled Healthcare VisitsBaseline, 6, 12, 18 monthsParticipants report at each survey time point the number of urgent care clinic visits, emergency room visits, and overnight hospital stays in the past month.
Change in FallsBaseline, 6, 12, 18 monthsThe number of falls in the last 6 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid H Gustafson, PhD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026