ElderTree Smart System for Older Adults

Using Smart Devices to Implement an Evidence-based eHealth System for Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Treatment as usual (TAU); Behavioral: ElderTree on laptop (ET- LT); Behavioral: ElderTree on smart system (ET- SS)

• Study Type: Interventional
• Enrollment (Actual): 268
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Participants will receive treatment as usual (TAU).	Behavioral: Treatment as usual (TAU); Treatment as usual (TAU)
Experimental: ElderTree on laptop (ET- LT); Participants will receive ElderTree on a laptop.	Behavioral: ElderTree on laptop (ET- LT); 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)
Experimental: ElderTree on smart system (ET- SS); Participants will receive ElderTree on a smart system.	Behavioral: ElderTree on smart system (ET- SS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ElderTree Days of Use	Days of ElderTree use within a 4 month period before their survey date. The possible range for days of ElderTree use is 0 to 120.	baseline to 4 months, and 4 months to 8 months
Physical Quality of Life	Physical quality of life was measured using the 12-item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. 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 physical quality of life. The possible range is 16.2-67.7.	Baseline, 4 months, 8 months
Pain Intensity	Pain intensity was measured using a single item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The item asked participants to answer regarding the past 7 days. The raw score of the item was used (range: 0-10); with higher values indicating more pain intensity.	Baseline, 4 months, 8 months
Number of Participants Readmitted Within 30-days	30-day readmissions were measured using a single item asking participants to answer regarding the past 4 months. The raw score, answering yes/no to having a 30-day readmission, was used. Those participants answering 'yes' to being readmitted in the last 30 days are reported for each time point.	Baseline, 4 months, 8 months
Health Distress	Health distress was measured using the 4-item Lorig Health Distress Scale. The items asked participants to answer regarding the past month. The measure was scored by averaged the items; with higher values indicating more health distress. Possible range is 0 to 5.	Baseline, 4 months, 8 months
Well-being	Well-being was measured using the 5-items World Health Organization (WHO) Well-Being Index. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating better well-being. Possible range is 0 to 25.	Baseline, 4 months, 8 months
Loneliness	Loneliness was measured using the 5-item NIH Toolbox Social Relationship Scale Loneliness. The items asked participants to answer regarding the past month. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more Loneliness. Possible range is 20 to 80.	Baseline, 4 months, 8 months
Irritability	Irritability was measured using the 5-item Brief Irritability Test. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating more irritability. Possible range is 5 to 30.	Baseline, 4 months, 8 months
Communication With Physicians	Communication with physicians was measured using the 3-item Lorig Communication with Physicians. The items asked participants to answer regarding the past 4 months. The measure was scored by averaging the items; with higher values indicating better communication with the healthcare provider. Possible range is 0 to 5.	Baseline, 4 months, 8 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: David H. Gustafson, PhD, UW-Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Chronic conditions; Voice-activated "smart" technology
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2020-0868; ENGR/INDUSTRIAL ENGR (Other Identifier: UW Madison); A195000 (Other Identifier: UW Madison); Protocol Version 10/20/2021 (Other Identifier: UW Madison); 1R18HS026853-01A1 (U.S. AHRQ Grant/Contract)

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