Chronic PainNCT04798196
ElderTree Smart System for Older Adults
A study testing ElderTree on laptop (ET- LT), ElderTree on smart system (ET- SS) and Treatment as usual (TAU) in people with Chronic Pain, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ElderTree on laptop (ET- LT), ElderTree on smart system (ET- SS) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 26 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53704
About this study
Official title: Using Smart Devices to Implement an Evidence-based eHealth System for Older Adults
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.
- Conditions
- Chronic Pain
- Being tested
- ElderTree on laptop (ET- LT), ElderTree on smart system (ET- SS), Treatment as usual (TAU)
- Keywords
- Chronic conditions, Voice-activated "smart" technology
- Medical subject headings
- Chronic Pain, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElderTree on laptop (ET- LT)Behavioural
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)Behavioural
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)Behavioural
Treatment as usual (TAU)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants will receive treatment as usual (TAU). Receives: Behavioral: Treatment as usual (TAU) |
| ElderTree on laptop (ET- LT) | Experimental | Participants will receive ElderTree on a laptop. Receives: Behavioral: ElderTree on laptop (ET- LT) |
| ElderTree on smart system (ET- SS) | Experimental | Participants will receive ElderTree on a smart system. Receives: Behavioral: ElderTree on smart system (ET- SS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score
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).
Measured: Baseline, 4 months, 8 months
Change in PROMIS Short Form v2.1 - Psychosocial Quality of Life Score
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.
Measured: Baseline, 4 months, 8 months
Secondary outcomes (9)
ElderTree Days of Use
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.
Measured: baseline to 4 months, and 4 months to 8 months
Physical Quality of Life
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.
Measured: Baseline, 4 months, 8 months
Pain Intensity
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.
Measured: Baseline, 4 months, 8 months
Number of Participants Readmitted Within 30-days
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.
Measured: Baseline, 4 months, 8 months
Health Distress
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.
Measured: Baseline, 4 months, 8 months
Well-being
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.
Measured: Baseline, 4 months, 8 months
Loneliness
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.
Measured: Baseline, 4 months, 8 months
Irritability
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.
Measured: Baseline, 4 months, 8 months
Communication With Physicians
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.
Measured: Baseline, 4 months, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start29 Jul 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- David H. Gustafson, PhD, Principal investigator, UW-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798196
- Sponsor's protocol ID
- 2020-0868
- Other IDs
- A195000, Protocol Version 10/20/2021, ENGR/INDUSTRIAL ENGR, 1R18HS026853-01A1
- Status last verified
- Oct 2024
- First submitted
- 11 Mar 2021
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landucci G, Gustafson DH Sr, Mares ML, Pe-Romashko K, Curtin JJ, Hu Y, Maus A, Thompson K, Saunders S, Brown K, Woodburn J, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2025 Nov 18;8:e75991. doi: 10.2196/75991.
PubMed 40961249Gustafson 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.
PubMed 35511229
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smart Devices to Implement an Evidence-based eHealth System for Older Adults
- ClinicalTrials.gov ID
- NCT04798196
- Acronym / sponsor ID
- 2020-0868
- Conditions
- Chronic Pain
- Keywords
- Chronic conditions, Voice-activated "smart" technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: Treatment as usual (TAU)Participants will receive treatment as usual (TAU). |
| ElderTree on laptop (ET- LT) | Experimental | Behavioral: ElderTree on laptop (ET- LT)Participants will receive ElderTree on a laptop. |
| ElderTree on smart system (ET- SS) | Experimental | Behavioral: ElderTree on smart system (ET- SS)Participants will receive ElderTree on a smart system. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- Require an interpreter
- Have a medical diagnosis of any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | ElderTree 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. | Behavioural | ElderTree on smart system (ET- SS) |
| Treatment as usual (TAU)Treatment as usual (TAU) | Behavioural | Control group |
Primary outcome
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.
9 secondary outcomes
ElderTree Days of Use
Time frame: baseline to 4 months, and 4 months to 8 months
Physical Quality of Life
Time frame: Baseline, 4 months, 8 months
Pain Intensity
Time frame: Baseline, 4 months, 8 months
Number of Participants Readmitted Within 30-days
Time frame: Baseline, 4 months, 8 months
Health Distress
Time frame: Baseline, 4 months, 8 months
Well-being
Time frame: Baseline, 4 months, 8 months
Loneliness
Time frame: Baseline, 4 months, 8 months
Irritability
Time frame: Baseline, 4 months, 8 months
Communication With Physicians
Time frame: Baseline, 4 months, 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40961249Landucci G, Gustafson DH Sr, Mares ML, Pe-Romashko K, Curtin JJ, Hu Y, Maus A, Thompson K, Saunders S, Brown K, Woodburn J, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2025 Nov 18;8:e75991. doi: 10.2196/75991.
- Derived from this study: PubMed 35511229Gustafson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H. Gustafson, PhD principal investigator
UW-Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ElderTree on laptop (ET- LT), ElderTree on smart system (ET- SS) and Treatment as usual (TAU) in people with Chronic Pain, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score (time frame: Baseline, 4 months, 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.