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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Conditions, Multiple
• Intervention / Treatment: Behavioral: ET-Text (Laptop); Behavioral: ET-Voice (Smart System)

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group (ET-Text); Participants will receive ElderTree on a laptop.	Behavioral: ET-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.
Experimental: Experimental group (ET-Voice); Participants will receive ElderTree on a smart system.	Behavioral: ET-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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. There are 4 questions with a possible score of 4-16. Lower scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in pain interference as assessed by the PROMIS-29 v2.1	Participant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in 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.	Baseline, 6, 12, 18 months
Change in fatigue as assessed by the PROMIS-29 v2.1	Participant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in sleep as assessed by the PROMIS-29 v2.1	Participant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in anxiety as assessed by the PROMIS-29 v2.1	Participant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in depression as assessed by the PROMIS-29 v2.1	Participant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in social roles as assessed by the PROMIS-29 v2.1	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.	Baseline, 6, 12, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in overall ElderTree use across the 12-month intervention	Amount of ElderTree use will be calculated by number of logons in the ET portal.	up to 12 months
Change in NIH Toolbox Loneliness Survey scores	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.	Baseline, 6, 12, 18 months
Change in Physical Function as assessed by PROMIS-43	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.	Baseline, 6, 12, 18 months
Change in Pain Interference as assessed by PROMIS-43	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.	Baseline, 6, 12, 18 months
Change in Fatigue as assessed by PROMIS-43	Participant reported measure of fatigue. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in Sleep Disturbance as assessed by PROMIS-43	Participant reported measure of sleep disturbance. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in Anxiety as assessed by PROMIS-43	Participant reported measure of anxiety. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in Depression as assessed by PROMIS-43	Participant reported measure of depression. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes.	Baseline, 6, 12, 18 months
Change in Social Roles as assessed by PROMIS-43	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.	Baseline, 6, 12, 18 months
Change in Lorig Health Distress Scale Score	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).	Baseline, 6, 12, 18 months
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.	Baseline, 6, 12, 18 months
Change in Falls	The number of falls in the last 6 months	Baseline, 6, 12, 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NIH Toolbox Loneliness Survey scores	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.	Baseline, 6, 12, 18 months
ElderTree usefulness	This is a 9 item scale created for the study to assess the usefulness of ElderTree. Participants rate items on a 4-point scale, with options ranging from not at all (1) to very much so (4), with higher scores indicating finding ElderTree useful.	6, 12, 18 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: David H Gustafson, PhD, University of Wisconsin, Madison

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Actual): December 3, 2025
• Study Completion (Actual): December 3, 2025

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Older adults; Voice-activated "smart" technology
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Multiple Chronic Conditions
• Other Study ID Numbers: 2020-0984; A195000 (Other Identifier: UW Madison); 1R61HL151870-01A1 (U.S. NIH Grant/Contract); 5R33HL151870 (U.S. NIH Grant/Contract); Protocol Version 11/4/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No