ElderTree Smart System for Older Adults

NCT04798196 | Completed Results DMC

• 5 other identifiers: 2020-0868A195000Protocol Version 10/20/2021ENGR/INDUSTRIAL ENGR1R18HS026853-01A1
• Study Type: interventional
• Target: 268
• 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. The primary purpose of this study is to investigate whether voice-activated "smart" technology increases adoption and sustains use of an evidence-based electronic health intervention (Elder Tree, or ET) for older adults with multiple chronic conditions, and thereby improves its potential to widely enhance quality of life and health outcomes. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. An Agency for Health Care Research and Quality (AHRQ)-funded randomized controlled trial (RCT) found that ET improved quality of life and other factors among high users of primary care with multiple chronic conditions such as diabetes and hypertension. However, many people did not use it extensively, which is a common problem with all web apps.

Conditions

Chronic Pain

Keywords

Chronic conditions; Voice-activated "smart" technology

Outcome Measures

Primary Outcomes (2)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score

  Pain interference was measured using the 4-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more pain interference. The possible range is 41.1 to 76.3 (PROMIS scores reported here have weighted ranges).

  Baseline, 4 months, 8 months

• Change in PROMIS Short Form v2.1 - Psychosocial Quality of Life Score

  Psychosocial quality of life was measured using the 12-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating better quality of life. The possible range is 21.2 to 67.6.

  Baseline, 4 months, 8 months

Secondary Outcomes (9)

• ElderTree Days of Use

  baseline to 4 months, and 4 months to 8 months

• Physical Quality of Life

  Baseline, 4 months, 8 months

• Pain Intensity

  Baseline, 4 months, 8 months

• Number of Participants Readmitted Within 30-days

  Baseline, 4 months, 8 months

• Health Distress

  Baseline, 4 months, 8 months

Study Arms (3)

Control group

PLACEBO COMPARATOR

Participants will receive treatment as usual (TAU).

Behavioral: Treatment as usual (TAU)

ElderTree on laptop (ET- LT)

EXPERIMENTAL

Participants will receive ElderTree on a laptop.

Behavioral: ElderTree on laptop (ET- LT)

ElderTree on smart system (ET- SS)

EXPERIMENTAL

Participants will receive ElderTree on a smart system.

Behavioral: ElderTree on smart system (ET- SS)

Interventions

ElderTree on laptop (ET- LT) BEHAVIORAL

ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. 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. 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-LT arm will access ET on Laptop (ET- LT)

ElderTree on laptop (ET- LT)

ElderTree on smart system (ET- SS) BEHAVIORAL

ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. 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. 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. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided.

ElderTree on smart system (ET- SS)

Treatment as usual (TAU) BEHAVIORAL

Treatment as usual (TAU)

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥60 years old;
• Have been treated in University of Wisconsin (UW) Health clinics, with no plans to leave during the study period (only relevant for UW Health patients, not patients recruited from the community);
• Have a chronic pain diagnosis AND a medical diagnoses of three or more of the following common chronic conditions: Chronic obstructive pulmonary disease (COPD), asthma, diabetes, hyperlipidemia, hypertension, ischemic heart disease, atrial fibrillation, heart failure, stroke, BMI 30+, cancer, chronic kidney disease, depression, osteoporosis, arthritis, or dizziness/falls/loss of vestibular function;
• Be willing to share healthcare use (e.g. 30-day readmissions) in electronic health records (only relevant for UW Health patients, not patients recruited from the community); and
• Allow researchers to share information about a patient's health status with their primary care physician (PCP).

You may not qualify if:

• Require an interpreter
• Have a medical diagnosis of any of the following:
• Alzheimer's
• Schizophrenia/other psychotic disorders
• Dementia
• Autism spectrum disorder
• Known terminal illness with less than 6 months to live
• Acute medical problem requiring immediate hospitalization

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53704, United States

Location

Related Publications (2)

• Landucci G, Gustafson DH Sr, Mares ML, Pe-Romashko K, Curtin JJ, Hu Y, Maus A, Thompson K, Saunders S, Brown K, Woodburn J, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2025 Nov 18;8:e75991. doi: 10.2196/75991.

  PMID: 40961249 DERIVED

• Gustafson DH Sr, Mares ML, Johnston DC, Landucci G, Pe-Romashko K, Vjorn OJ, Hu Y, Gustafson DH Jr, Maus A, Mahoney JE, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 5;11(5):e37522. doi: 10.2196/37522.

  PMID: 35511229 DERIVED

MeSH Terms

Conditions

Chronic Pain; Chronic Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Gina Landucci
• Organization: UW-Madison

gina.landucci@wisc.edu

(608) 890-1440

Study Officials

• David H. Gustafson, PhD

  UW-Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: March 11, 2021
• First Posted: March 15, 2021
• Study Start: July 29, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)