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Chronic Conditions, MultipleNCT05240534

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

A study testing ET-Text (Laptop) and ET-Voice (Smart System) in people with Chronic Conditions, Multiple, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Chronic Conditions, Multiple
What is being tested?
ET-Text (Laptop) and ET-Voice (Smart System)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
502 participants
Where
1 siteUnited States
Study dates
29 Apr 2022to 3 Dec 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

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

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. Elder Tree (ET) is an evidence-based electronic health intervention 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.

Being tested
ET-Text (Laptop), ET-Voice (Smart System)
Keywords
Voice-activated "smart" technology, Older adults
Medical subject headings
Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ET-Text (Laptop)Behavioural

    Also called ET-LT

    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.

  • ET-Voice (Smart System)Behavioural

    Also called ET-SS

    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.

Study groups in NCT05240534
Study groupRoleWhat they receive
Control group (ET-Text)Placebo comparatorParticipants will receive ElderTree on a laptop.
Receives: Behavioral: ET-Text (Laptop)
Experimental group (ET-Voice)ExperimentalParticipants will receive ElderTree on a smart system.
Receives: Behavioral: ET-Voice (Smart System)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1

    Participant reported measure of overall health and level of physical disability. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  2. Pain Interference as Assessed by the PROMIS-29 v2.1

    Participant reported measure of pain interference. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  3. Pain Intensity as Assessed by the PROMIS-29 v2.1

    Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  4. Fatigue as Assessed by the PROMIS-29 v2.1

    Participant reported measure of fatigue. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  5. Sleep as Assessed by the PROMIS-29 v2.1

    Participant reported measure of sleep disturbance. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  6. Anxiety as Assessed by the PROMIS-29 v2.1

    Participant reported measure of anxiety. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  7. Depression as Assessed by the PROMIS-29 v2.1

    Participant reported measure of depression. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  8. Social Roles as Assessed by the PROMIS-29 v2.1

    Participant reported measure of satisfaction with participation in social roles. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

Secondary outcomes (12)
  1. ElderTree Days of Use

    Amount of ElderTree (ET) use will be calculated by the number of days.

    Measured: up to 12 months

  2. Physical Function as Assessed by PROMIS-43

    Participant reported measure of overall health and level of physical disability. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  3. Pain Interference as Assessed by PROMIS-43

    Participant reported measure of pain interference. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  4. Fatigue as Assessed by PROMIS-43

    Participant reported measure of fatigue. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  5. Sleep Disturbance as Assessed by PROMIS-43

    Participant reported measure of sleep disturbance. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  6. Anxiety as Assessed by PROMIS-43

    Participant reported measure of anxiety. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  7. Depression as Assessed by PROMIS-43

    Participant reported measure of depression. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  8. Social Roles as Assessed by PROMIS-43

    Participant reported measure of satisfaction with participation in social roles. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.

    Measured: Baseline, 6, 12, 18 months

  9. Lorig Health Distress Scale Score

    Health distress was measured using the 4-item Lorig Health Distress Scale. The items asked participants to answer regarding the past month. The measure was scored by averaging the items; with higher values indicating more health distress. Possible range is 0 to 5.

    Measured: Baseline, 6, 12, 18 months

  10. NIH Toolbox Loneliness Survey Scores

    NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate greater perceived loneliness.

    Measured: Baseline, 6, 12, 18 months

  11. Number of Unscheduled Healthcare Visits

    Participants report at each survey time point the number of urgent care clinic visits, emergency room visits, and overnight hospital stays in the past month.

    Measured: Baseline, 6, 12, 18 months

  12. Number of Falls in the Previous 6 Months

    The number of falls in the last 6 months

    Measured: Baseline, 6, 12, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start29 Apr 2022
  3. Primary completion3 Dec 2025
  4. Study completion3 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240534
Sponsor's protocol ID
2020-0984
Other IDs
A195000, Protocol Version 11/4/2024, 1R61HL151870-01A1, 5R33HL151870
Status last verified
Sep 2026
First submitted
4 Feb 2022
Last updated
20 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gustafson DH Sr, Mares ML, Johnston DC, Curtin JJ, Pe-Romashko K, Landucci G. Comparison of Smart Display Versus Laptop Platforms for an eHealth Intervention to Improve Functional Health for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Apr 3;14:e64449. doi: 10.2196/64449.

    PubMed 40080672

Questions about this trial

What is this clinical trial studying?

A study testing ET-Text (Laptop) and ET-Voice (Smart System) in people with Chronic Conditions, Multiple, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1 (time frame: Baseline, 6, 12, 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05240534, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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