Clinical trial NCT05240534: ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)
Official title: Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Conditions, Multiple
Keywords: Voice-activated "smart" technology
Older adults
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-02-15
Enrollment: 502
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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. 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.


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)

Primary outcomes:
measure: Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
timeFrame: Baseline, 6, 12, 18 months
measure: Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
timeFrame: Baseline, 6, 12, 18 months
measure: Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
timeFrame: Baseline, 6, 12, 18 months
measure: Change in fatigue as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
timeFrame: Baseline, 6, 12, 18 months
measure: Change in sleep as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
timeFrame: Baseline, 6, 12, 18 months
measure: Change in anxiety as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
timeFrame: Baseline, 6, 12, 18 months
measure: Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
timeFrame: Baseline, 6, 12, 18 months
Secondary outcomes:
measure: Change in overall ElderTree use across the 12-month intervention
timeFrame: up to 12 months
measure: Change in healthcare use (primary care, specialist, urgent care, emergency room visits, and 30-day readmissions
timeFrame: Baseline, 6, 12, 18 months
measure: Change in health distress
timeFrame: Baseline, 6, 12, 18 months
measure: Change in function and disability
timeFrame: Baseline, 6, 12, 18 months
measure: Change in well-being
timeFrame: Baseline, 6, 12, 18 months
measure: Change in symptom distress
timeFrame: Baseline, 6, 12, 18 months
measure: Change in falls
timeFrame: Baseline, 6, 12, 18 months
measure: ElderTree ease of use
timeFrame: 6, 12, 18 months
Other outcomes:
measure: Change in NIH Toolbox Loneliness Survey scores
timeFrame: Baseline, 6, 12, 18 months
measure: ElderTree usefulness
timeFrame: 6, 12, 18 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David H Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References: