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Clinical Trials/NCT05240534
NCT05240534
Active, Not Recruiting
N/A

Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)

University of Wisconsin, Madison1 site in 1 country502 target enrollmentApril 29, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Conditions, Multiple
Sponsor
University of Wisconsin, Madison
Enrollment
502
Locations
1
Primary Endpoint
Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.
Status
Active, Not Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 29, 2022
End Date
April 30, 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

Time Frame: Baseline, 6, 12, 18 months

Participant reported measure of overall health and level of physical disability. There are 4 questions with a possible score of 4-16. Lower scores indicate worse outcomes.

Change in anxiety as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

Time Frame: Baseline, 6, 12, 18 months

Participant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

Time Frame: Baseline, 6, 12, 18 months

Participant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

Time Frame: Baseline, 6, 12, 18 months

Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.

Change in fatigue as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

Time Frame: Baseline, 6, 12, 18 months

Participant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in sleep as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

Time Frame: Baseline, 6, 12, 18 months

Participant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

Time Frame: Baseline, 6, 12, 18 months

Participant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.

Secondary Outcomes

  • Change in overall ElderTree use across the 12-month intervention(up to 12 months)
  • Change in health distress(Baseline, 6, 12, 18 months)
  • Change in falls(Baseline, 6, 12, 18 months)
  • Change in healthcare use (primary care, specialist, urgent care, emergency room visits, and 30-day readmissions(Baseline, 6, 12, 18 months)
  • Change in well-being(Baseline, 6, 12, 18 months)
  • Change in symptom distress(Baseline, 6, 12, 18 months)
  • Change in function and disability(Baseline, 6, 12, 18 months)
  • ElderTree ease of use(6, 12, 18 months)

Study Sites (1)

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