Clinical trial NCT04798196: ElderTree Smart System for Older Adults
Official title: Using Smart Devices to Implement an Evidence-based eHealth System for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic conditions
Voice-activated "smart" technology
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-03-15
Enrollment: 268
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score
timeFrame: Baseline, 4 months, 8 months
measure: Change in PROMIS Short Form v2.1 - Psychosocial Quality of Life Score
timeFrame: Baseline, 4 months, 8 months
Secondary outcomes:
measure: ElderTree Days of Use
timeFrame: baseline to 4 months, and 4 months to 8 months
measure: Physical Quality of Life
timeFrame: Baseline, 4 months, 8 months
measure: Pain Intensity
timeFrame: Baseline, 4 months, 8 months
measure: Number of Participants Readmitted Within 30-days
timeFrame: Baseline, 4 months, 8 months
measure: Health Distress
timeFrame: Baseline, 4 months, 8 months
measure: Well-being
timeFrame: Baseline, 4 months, 8 months
measure: Loneliness
timeFrame: Baseline, 4 months, 8 months
measure: Irritability
timeFrame: Baseline, 4 months, 8 months
measure: Communication With Physicians
timeFrame: Baseline, 4 months, 8 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW-Madison
name: David H. Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.