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Clinical Trials/NCT04798196
NCT04798196
Completed
N/A

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

University of Wisconsin, Madison1 site in 1 country268 target enrollmentJuly 29, 2021
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Wisconsin, Madison
Enrollment
268
Locations
1
Primary Endpoint
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score
Status
Completed
Last Updated
last year

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.

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.

Registry
clinicaltrials.gov
Start Date
July 29, 2021
End Date
September 26, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • Autism spectrum disorder
  • Known terminal illness with less than 6 months to live
  • Acute medical problem requiring immediate hospitalization

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 4 months, 8 months

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).

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

Time Frame: Baseline, 4 months, 8 months

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.

Secondary Outcomes

  • 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)
  • Well-being(Baseline, 4 months, 8 months)
  • Loneliness(Baseline, 4 months, 8 months)
  • Irritability(Baseline, 4 months, 8 months)
  • Communication With Physicians(Baseline, 4 months, 8 months)

Study Sites (1)

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