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Completed

NCT Number: NCT05240534

ElderTree Via a Voice Activated Device for Managing Chronic Health 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. 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.

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Key information

Conditions

Chronic Conditions, Multiple Chronic Disease Disease Attributes Multiple Chronic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ET-Text (Laptop)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1

    Time frame: Baseline, 6, 12, 18 months

    Participant 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.

  2. Change in pain interference as assessed by the PROMIS-29 v2.1

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

  3. Change in pain intensity as assessed by the PROMIS-29 v2.1

    Time frame: Baseline, 6, 12, 18 months

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

  4. Change in fatigue as assessed by the PROMIS-29 v2.1

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

  5. Change in sleep as assessed by the PROMIS-29 v2.1

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

  6. Change in anxiety as assessed by the PROMIS-29 v2.1

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

  7. Change in depression as assessed by the PROMIS-29 v2.1

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

  8. Change in social roles as assessed by the PROMIS-29 v2.1

    Time frame: Baseline, 6, 12, 18 months

    Participant 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 outcomes

  1. Change in overall ElderTree use across the 12-month intervention

    Time frame: up to 12 months

    Amount of ElderTree use will be calculated by number of logons in the ET portal.

  2. Change in Physical Function as assessed by PROMIS-43

    Time frame: Baseline, 6, 12, 18 months

    Participant 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.

  3. Change in Pain Interference as assessed by PROMIS-43

    Time frame: Baseline, 6, 12, 18 months

    Participant 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.

  4. Change in Fatigue as assessed by PROMIS-43

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of fatigue. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.

  5. Change in Sleep Disturbance as assessed by PROMIS-43

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of sleep disturbance. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.

  6. Change in Anxiety as assessed by PROMIS-43

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of anxiety. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.

  7. Change in Depression as assessed by PROMIS-43

    Time frame: Baseline, 6, 12, 18 months

    Participant reported measure of depression. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.

  8. Change in Social Roles as assessed by PROMIS-43

    Time frame: Baseline, 6, 12, 18 months

    Participant 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.

  9. Change in Lorig Health Distress Scale Score

    Time frame: Baseline, 6, 12, 18 months

    Lorig 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).

  10. Change in NIH Toolbox Loneliness Survey scores

    Time frame: Baseline, 6, 12, 18 months

    NIH 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.

  11. Number of Unscheduled Healthcare Visits

    Time frame: Baseline, 6, 12, 18 months

    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.

  12. Change in Falls

    Time frame: Baseline, 6, 12, 18 months

    The number of falls in the last 6 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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