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

NCT05240534 | Active Not Recruiting DMC

• 5 other identifiers: 2020-0984A195000Protocol Version 3/2/20231R61HL151870-01A15R33HL151870
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Conditions, Multiple

Keywords

Voice-activated "smart" technology; Older adults

Outcome Measures

Primary Outcomes (7)

• Change in functional health 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 Patient-Reported Outcomes Measurement Information System (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 Patient-Reported Outcomes Measurement Information System (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 Patient-Reported Outcomes Measurement Information System (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 Patient-Reported Outcomes Measurement Information System (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 Patient-Reported Outcomes Measurement Information System (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 Patient-Reported Outcomes Measurement Information System (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

Secondary Outcomes (8)

• Change in overall ElderTree use across the 12-month intervention

  up to 12 months

• Change in healthcare use (primary care, specialist, urgent care, emergency room visits, and 30-day readmissions

  Baseline, 6, 12, 18 months

• Change in health distress

  Baseline, 6, 12, 18 months

• Change in function and disability

  Baseline, 6, 12, 18 months

• Change in well-being

  Baseline, 6, 12, 18 months

Other Outcomes (2)

• Change in NIH Toolbox Loneliness Survey scores

  Baseline, 6, 12, 18 months

• ElderTree usefulness

  6, 12, 18 months

Study Arms (2)

Control group (ET-Text)

PLACEBO COMPARATOR

Participants will receive ElderTree on a laptop.

Behavioral: ET-Text (Laptop)

Experimental group (ET-Voice)

EXPERIMENTAL

Participants will receive ElderTree on a smart system.

Behavioral: ET-Voice (Smart System)

Interventions

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.

Control group (ET-Text)

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.

Experimental group (ET-Voice)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• 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.

  PMID: 40080672 DERIVED

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

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

Study Officials

• David H Gustafson, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: April 29, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)