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| ID | Type | Description | Link |
|---|---|---|---|
| A195000 | Other Identifier | UW Madison | |
| Protocol Version 11/4/2024 | Other Identifier | UW Madison | |
| 1R61HL151870-01A1 | U.S. NIH Grant/Contract | View source | |
| 5R33HL151870 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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. Patients often struggle with treatment adherence and the emotional and physical burdens of self-management and health tracking. Chronic conditions reduce quality of life (QOL) and increase loneliness, which exacerbate those conditions.
The primary purpose of this study is to investigate whether a voice-based platform is better for delivering an electronic health intervention to older adults than a text/typing-based platform. We have an evidence-based electronic health intervention (Elder Tree, ET) that has been shown to improve quality of life, physical and socio-emotional health outcomes for older adults with multiple chronic conditions when delivered via a text/typing-based system. The current project would test whether such patients would benefit even more if ET were delivered via a voice-based system (vs. the text-based system) because they would use it more consistently. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (ET-Text) | Placebo Comparator | Participants will receive ElderTree on a laptop. |
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| Experimental group (ET-Voice) | Experimental | Participants will receive ElderTree on a smart system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET-Text (Laptop) | Behavioral | ElderTree (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. Like all CHESS systems, 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-Text arm will access ET on Laptop. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1 | Participant reported measure of overall health and level of physical disability. There are 4 questions with a possible score of 4-16. Lower scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in pain interference as assessed by the PROMIS-29 v2.1 | Participant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in pain intensity as assessed by the PROMIS-29 v2.1 | Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in fatigue as assessed by the PROMIS-29 v2.1 | Participant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in sleep as assessed by the PROMIS-29 v2.1 | Participant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in anxiety as assessed by the PROMIS-29 v2.1 | Participant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in overall ElderTree use across the 12-month intervention | Amount of ElderTree use will be calculated by number of logons in the ET portal. | up to 12 months |
| Change in Physical Function as assessed by PROMIS-43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Gustafson, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40080672 | Derived | Gustafson DH Sr, Mares ML, Johnston DC, Curtin JJ, Pe-Romashko K, Landucci G. Comparison of Smart Display Versus Laptop Platforms for an eHealth Intervention to Improve Functional Health for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Apr 3;14:e64449. doi: 10.2196/64449. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2022 | Jun 15, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ET-Voice (Smart System) | Behavioral | ElderTree (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. Like all CHESS systems, 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-Voice arm will access ET on a smart speaker. Voice-activated devices can potentially be easy to use, even by those with limited dexterity or computer experience. |
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| Baseline, 6, 12, 18 months |
| Change in depression as assessed by the PROMIS-29 v2.1 | Participant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in social roles as assessed by the PROMIS-29 v2.1 | Participant reported measure of satisfaction with participation in social roles, there are 4 questions, with a possible score of 4-20. Lower scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
Participant reported measure of overall health and level of physical disability. There are 6 questions with a possible score of 6-30. Lower scores indicate worse outcomes.
| Baseline, 6, 12, 18 months |
| Change in Pain Interference as assessed by PROMIS-43 | Participant reported measure of overall health and level of physical disability. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in Fatigue as assessed by PROMIS-43 | Participant reported measure of fatigue. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in Sleep Disturbance as assessed by PROMIS-43 | Participant reported measure of sleep disturbance. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in Anxiety as assessed by PROMIS-43 | Participant reported measure of anxiety. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in Depression as assessed by PROMIS-43 | Participant reported measure of depression. There are 6 questions with a possible score of 6-30. Higher scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in Social Roles as assessed by PROMIS-43 | Participant reported measure of satisfaction with participation in social roles. There are 6 questions with a possible score of 6-30. Lower scores indicate worse outcomes. | Baseline, 6, 12, 18 months |
| Change in Lorig Health Distress Scale Score | 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, 6, 12, 18 months |
| 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, 6, 12, 18 months |
| Number of Unscheduled Healthcare Visits | Participants report at each survey time point the number of urgent care clinic visits, emergency room visits, and overnight hospital stays in the past month. | Baseline, 6, 12, 18 months |
| Change in Falls | The number of falls in the last 6 months | Baseline, 6, 12, 18 months |