Back to resultsElderTree Smart System for Older Adults
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ElderTree on laptop (ET- LT)
ElderTree on smart system (ET- SS)
Treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring Chronic conditions, Voice-activated "smart" technology
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 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
Sites / Locations
- University of Wisconsin School of Medicine and Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control group
ElderTree on laptop (ET- LT)
ElderTree on smart system (ET- SS)
Arm Description
Participants will receive treatment as usual (TAU).
Participants will receive ElderTree on a laptop.
Participants will receive ElderTree on a smart system.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Number of logons in ET per week
Amount of ET use will be calculated by number of logons in the ET portal.
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.
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.
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
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.
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).
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.
Number of participants with 30-day readmits
Data will be collected from electronic health record
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
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.
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.
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.
Full Information
NCT ID
NCT04798196
First Posted
March 11, 2021
Last Updated
October 3, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT04798196
Brief Title
ElderTree Smart System for Older Adults
Official Title
Using Smart Devices to Implement an Evidence-based eHealth System for Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
September 26, 2023 (Actual)
Study Completion Date
September 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic conditions, Voice-activated "smart" technology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants will receive treatment as usual (TAU).
Arm Title
ElderTree on laptop (ET- LT)
Arm Type
Experimental
Arm Description
Participants will receive ElderTree on a laptop.
Arm Title
ElderTree on smart system (ET- SS)
Arm Type
Experimental
Arm Description
Participants will receive ElderTree on a smart system.
Intervention Type
Behavioral
Intervention Name(s)
ElderTree on laptop (ET- LT)
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
ElderTree on smart system (ET- SS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Treatment as usual (TAU)
Primary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a score
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in PROMIS Short Form v1.0 - Depression 4a score
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in PROMIS Short Form v1.0 - Pain interference 4a score
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in PROMIS Short Form v1.0 - Ability to participate in social roles and activities 4a score
Description
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.
Time Frame
Baseline, 4 months, 8 months
Secondary Outcome Measure Information:
Title
Number of logons in ET per week
Description
Amount of ET use will be calculated by number of logons in the ET portal.
Time Frame
up to 8 months
Title
Change in PROMIS Item Bank v2.0 - Physical Function - Short Form 4a
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in Late Life Function and Disability Instrument (FDI) Score
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in the score of Lorig communication with physician scale
Description
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
Time Frame
Baseline, 4 months, 8 months
Title
Change in World Health Organization- Five Well-Being Index (WHO-5)
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in Lorig Health Distress Scale
Description
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).
Time Frame
Baseline, 4 months, 8 months
Title
Change in NIH Toolbox Loneliness Survey scores
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Number of participants with 30-day readmits
Description
Data will be collected from electronic health record
Time Frame
up to 8 months
Title
Change in the Brief Irritability Test (BITe) score
Description
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
Time Frame
Baseline, 4 months, 8 months
Title
Change in PROMIS Pain Intensity Item
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in PROMIS Short Form v1.0 - Fatigue 4a score
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Change in PROMIS Short Form v1.0 - Sleep disturbance 4a score
Description
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.
Time Frame
Baseline, 4 months, 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H. Gustafson, PhD
Organizational Affiliation
UW-Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35511229
Citation
Gustafson DH Sr, Mares ML, Johnston DC, Landucci G, Pe-Romashko K, Vjorn OJ, Hu Y, Gustafson DH Jr, Maus A, Mahoney JE, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 5;11(5):e37522. doi: 10.2196/37522.
Results Reference
derived
Learn more about this trial
ElderTree Smart System for Older Adults
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