ElderTree Smart System for Older Adults

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798196
• Other study ID #: 2020-0868
• Secondary ID: A195000Protocol
• Status: Completed
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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 EHRs (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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• ElderTree on laptop (ET- LT)
ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-LT arm will access ET on Laptop (ET- LT)
• ElderTree on smart system (ET- SS)
ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided.
• Treatment as usual (TAU)
Treatment as usual (TAU)

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a score	Participant reported measure of anxiety, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.	Baseline, 4 months, 8 months
Primary	Change in PROMIS Short Form v1.0 - Depression 4a score	Participant reported measure of depression collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.	Baseline, 4 months, 8 months
Primary	Change in PROMIS Short Form v1.0 - Pain interference 4a score	Participant reported measure of pain interference, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.	Baseline, 4 months, 8 months
Primary	Change in PROMIS Short Form v1.0 - Ability to participate in social roles and activities 4a score	Participant reported measure of one's ability to participate in social roles and other activities, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Lower scores indicate worse outcomes.	Baseline, 4 months, 8 months
Secondary	Number of logons in ET per week	Amount of ET use will be calculated by number of logons in the ET portal.	up to 8 months
Secondary	Change in PROMIS Item Bank v2.0 - Physical Function - Short Form 4a	Participant reported measure of overall health, level of physical disability and general well-being, collected as part of the PROMIS-29 v2.1 profile. There are four questions with a possible score of four to 16. Lower scores indicate worse outcomes.	Baseline, 4 months, 8 months
Secondary	Change in Late Life Function and Disability Instrument (FDI) Score	FDI evaluates self-reported difficulty a person has in performing activities of daily living tasks. There are 32 items with response options of "none," "a little," "some," "quite a lot," and "cannot do." An additional eight items for participants who use a walking device. Scores range from 1-5 with higher scores indicating higher levels of functioning.	Baseline, 4 months, 8 months
Secondary	Change in the score of Lorig communication with physician scale	Lorig Communication with Physicians scale is a 3-item scale used to determine how patients prepare for visits with their healthcare provider as well as communication utilized during their visit. Patients circle the number (0-5) that corresponds with how often they utilize the communication item being measured (0=never, 3=fairly often, 5=always, etc). The healthcare provider administering the scale finds the mean of the items circled to determine the score of the scale. Higher scores correspondence to more preparedness for physician visit	Baseline, 4 months, 8 months
Secondary	Change in World Health Organization- Five Well-Being Index (WHO-5)	The World Health Organization- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. The WHO-5 consists of five statements, which respondents rate from 'All of the time = 5' to 'At no time = 0'. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.	Baseline, 4 months, 8 months
Secondary	Change in Lorig Health Distress Scale	Lorig Health Distress Scale is a self-reported measure. It has questions about how participant feel and how things have been during the past month. It is a 4 item scale. Each item can be score from 0-none of the time to 5- all the time. Higher scores corresponds to more amount of time the participant has been distressed about health (e.g., discouraged, worried, fearful, frustrated by health problems).	Baseline, 4 months, 8 months
Secondary	Change in NIH Toolbox Loneliness Survey scores	NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness.; Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness.	Baseline, 4 months, 8 months
Secondary	Number of participants with 30-day readmits	Data will be collected from electronic health record	up to 8 months
Secondary	Change in the Brief Irritability Test (BITe) score	Brief Irritability Test (BITe) is a 5-item measure of irritability. Irritability is the proneness and susceptibility towards states of frustration and annoyance despite little provocation. The test consists of 5 items. Each item can be answered from Never = 1, Rarely = 2, Sometimes = 3, Often = 4, Very Often = 5, Always = 6. Total score ranges from 5-30. Higher score corresponds to higher irritability	Baseline, 4 months, 8 months
Secondary	Change in PROMIS Pain Intensity Item	Participant reported measure of pain intensity, collected as a part of the PROMIS-29 v2.1 profile. This is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.	Baseline, 4 months, 8 months
Secondary	Change in PROMIS Short Form v1.0 - Fatigue 4a score	Participant reported measure of fatigue, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.	Baseline, 4 months, 8 months
Secondary	Change in PROMIS Short Form v1.0 - Sleep disturbance 4a score	Participant reported measure of sleep disturbance, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.	Baseline, 4 months, 8 months