ElderTree Smart System for Older Adults

Not Applicable

Completed

Conditions: Chronic Pain

Interventions: Behavioral: Treatment as usual (TAU)
Behavioral: ElderTree on laptop (ET- LT)
Behavioral: ElderTree on smart system (ET- SS)

Registration Number: NCT04798196

Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 268

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Treatment as usual (TAU)	Participants will receive treatment as usual (TAU).
ElderTree on laptop (ET- LT)	ElderTree on laptop (ET- LT)	Participants will receive ElderTree on a laptop.
ElderTree on smart system (ET- SS)	ElderTree on smart system (ET- SS)	Participants will receive ElderTree on a smart system.

Primary Outcome Measures

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

Name	Time	Method
Health Distress	Baseline, 4 months, 8 months	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.
ElderTree Days of Use	baseline to 4 months, and 4 months to 8 months	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.
Physical Quality of Life	Baseline, 4 months, 8 months	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.
Pain Intensity	Baseline, 4 months, 8 months	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.
Number of Participants Readmitted Within 30-days	Baseline, 4 months, 8 months	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.
Well-being	Baseline, 4 months, 8 months	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.
Loneliness	Baseline, 4 months, 8 months	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.
Irritability	Baseline, 4 months, 8 months	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.
Communication With Physicians	Baseline, 4 months, 8 months	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.