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

NCT ID: NCT05240534

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2027-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control group (ET-Text)

Participants will receive ElderTree on a laptop.

Group Type: PLACEBO_COMPARATOR

ET-Text (Laptop)

Intervention Type: 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.

Experimental group (ET-Voice)

Participants will receive ElderTree on a smart system.

Group Type: EXPERIMENTAL

ET-Voice (Smart System)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H Gustafson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40080672 (View on PubMed)

Other Identifiers

A195000

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 3/2/2023

Identifier Type: OTHER

Identifier Source: secondary_id

1R61HL151870-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R33HL151870

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0984

Identifier Type: -

Identifier Source: org_study_id