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| ID | Type | Description | Link |
|---|---|---|---|
| A195010 | Other Identifier | UW Madison | |
| ENGR\INDUSTRIAL ENGR\CHESS | Other Identifier | UW Madison | |
| 1R01HL134146-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Multiple chronic conditions are common and expensive among patients aged ≥65 and are associated with lower quality of life, poorer response to treatment, worse medical and psychiatric outcomes, higher mortality, and higher costs of care.
The primary purpose of this study is to conduct a randomized clinical trial (RCT) to examine the effects of ElderTree --a web-based intervention--on health outcomes and healthcare use among older adults with several chronic health conditions, such as diabetes, high blood pressure, high cholesterol, COPD, BMI over 30, congestive heart failure, chronic kidney disease, arrhythmia/atrial fibrillation, chronic pain, arthritis.
The investigator's hypothesis is that patients assigned to TAU+ElderTree will have better quality of life and fewer primary care visits than those assigned to TAU+Internet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual (TAU) + Internet | Placebo Comparator | Patients will be given access to helpful websites such as National Institute on Aging. |
|
| Treatment as usual (TAU) + ElderTree | Experimental | Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as usual (TAU) + Internet | Other | Patients in this group will receive TAU+internet and links to helpful websites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Global Health Measure Score | Quality of life is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure. For consistency with other measures, the time frame has been modified to refer to the past 2 weeks. Scores are calculated using the HealthMeasures Scoring Service. Scores are a T-score metric with a mean of 50 and a standard deviation of 10 with a range of about 20 to 80. Higher scores indicate better quality of life. | Measured at baseline and 12 months |
| Psychological Flourishing Scale | Psychological well-being is assessed using the Psychological Flourishing Scale. The wording of items has been somewhat modified, including simplifying double-barreled items. For example, "I lead a purposeful and meaningful life" is shortened to "I lead a meaningful life." Scores are a sum of all items with a range from 8 to 40. Higher scores indicate a better well-being. | Baseline and 12-months |
| UCLA Loneliness Scale | Loneliness is measured using the 8 items from the UCLA Loneliness Scale with the highest factor loadings among older adults. Scores ranged from 8 to 40. Higher scores indicate more loneliness. | Baseline and 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Unhealthy Laboratory Scores | Laboratory scores are obtained from the patient's electronic health record (EHR) including blood pressure, HAC1 for diabetes, cholesterol, BMI. Some participants did not have this data. The final score is a fraction of the number of unhealthy labs over each persons total labs. Scores range from 0 to 1. Higher scores indicate more unhealthy lab records. | 12-months |
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Inclusion Criteria:
are ≥65 years old
have been treated in the University of Wisconsin Health clinics for at least the previous 18 months with no plans to leave during the study period
have 3 or more of the following chronic conditions: hypertension, hyperlipidemia, diabetes, arthritis, BMI over 30, chronic kidney disease, congestive heart failure, arrhythmia/atrial fibrillation, pulmonary heart disease or pulmonary vascular disease, chronic pain, COPD
report no current psychotic disorder that would prevent participation
have no acute medical problem requiring immediate hospitalization
be able to read and sign the consent form in English
have no known terminal illness
be willing to share health-related study data and
allow researchers to share information with their primary care physician
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| Name | Affiliation | Role |
|---|---|---|
| David H Gustafson, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health Clinics | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39642938 | Derived | Gustafson DH Sr, Mares ML, Johnston D, Vjorn OJ, Curtin JJ, Landucci G, Pe-Romashko K, Gustafson DH Jr, Shah DV. An eHealth Intervention to Improve Quality of Life, Socioemotional, and Health-Related Measures Among Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2024 Dec 6;7:e59588. doi: 10.2196/59588. | |
| 33605887 | Derived | Gustafson DH Sr, Mares ML, Johnston DC, Mahoney JE, Brown RT, Landucci G, Pe-Romashko K, Cody OJ, Gustafson DH Jr, Shah DV. A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 19;10(2):e25175. doi: 10.2196/25175. |
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Two participants signed the consent form and were randomized but did not start the study. One couldn't use the ET website due to macular degeneration. The other one decided he's not interested in using computers and ElderTree.
Recruitment was conducted from January 2018 to December 2019. The intervention period ended in June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual (TAU) + Internet | Patients will be given access to helpful websites such as National Institute on Aging. Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites. |
| FG001 | Treatment as Usual (TAU) + ElderTree | Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual (TAU) + Internet | Patients will be given access to helpful websites such as National Institute on Aging. Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites. |
| BG001 | Treatment as Usual (TAU) + ElderTree |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PROMIS Global Health Measure Score | Quality of life is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure. For consistency with other measures, the time frame has been modified to refer to the past 2 weeks. Scores are calculated using the HealthMeasures Scoring Service. Scores are a T-score metric with a mean of 50 and a standard deviation of 10 with a range of about 20 to 80. Higher scores indicate better quality of life. | Posted | Mean | Standard Deviation | T-score | Measured at baseline and 12 months |
|
up to 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual (TAU) + Internet | Patients will be given access to helpful websites such as National Institute on Aging. Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites. |
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We did not have health lab score baseline data for all participants
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CHESS Statistician | UW Madison | 6084772614 | ocody@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2019 | Jun 15, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 28, 2018 | Jul 14, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| D001168 | Arthritis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| TAU + ElderTree | Behavioral | For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits. |
|
| Falls | Falls were assessed by asking how often the participant had fallen in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen. Falls ranged from 0 to 14. | Baseline and 12-months |
| Symptom Distress | Symptom distress is assessed using a combined list of 20 symptoms and chronic conditions from the General Symptom Distress Scale and Bayliss Disease Burden Scale, assessing the severity of distress for each over the past 2 weeks (0=do not have this, 1=not very distressing, and 5=extremely distressing). Scores range from 0 to 100. Higher scores indicate more symptom distress. | Baseline and 12-months |
| Medication Adherence | Medication adherence is assessed with 8 items, 6 based on the Brief Medication Questionnaire by Svarstad et al. We simplified response options so that participants rate how often they had specific issues with medication (1=never and 5=always). On the basis of patients' experiences, we added 2 original items, "Feels like I no longer need it" and "Feels like I don't need the full dose. There were 8 items in total, summed to get a final score. Scores ranged from 8 to 40. Higher scores indicate less medication adherence. | Baseline and 12-months |
| Crisis Health Care Visits | Crisis health care was the total number of urgent care visits, emergency room visits, and hospitalizations combined. Reported is the average count of visits. Higher numbers indicate more visits. | Baseline and 12-months |
| Long-term Care | Long-term care was the number of nights spent in assisted living facilities and nursing homes over the past 3 months. Number of nights ranged from 0 to 92. Higher numbers indicate more nights spent. | Baseline and 12-months |
| Falls Requiring Medical Attention | Falls requiring medical attention was assessed by one item counting the number of times in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen and required medical attention. Falls needing medical attention ranged from 0 to 4. | Baseline and 12-months |
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health Insurance type | Count of Participants | Participants |
|
| Treatment as Usual (TAU) + ElderTree |
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits. |
|
|
| Primary | Psychological Flourishing Scale | Psychological well-being is assessed using the Psychological Flourishing Scale. The wording of items has been somewhat modified, including simplifying double-barreled items. For example, "I lead a purposeful and meaningful life" is shortened to "I lead a meaningful life." Scores are a sum of all items with a range from 8 to 40. Higher scores indicate a better well-being. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-months |
|
|
|
| Primary | UCLA Loneliness Scale | Loneliness is measured using the 8 items from the UCLA Loneliness Scale with the highest factor loadings among older adults. Scores ranged from 8 to 40. Higher scores indicate more loneliness. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-months |
|
|
|
| Secondary | Unhealthy Laboratory Scores | Laboratory scores are obtained from the patient's electronic health record (EHR) including blood pressure, HAC1 for diabetes, cholesterol, BMI. Some participants did not have this data. The final score is a fraction of the number of unhealthy labs over each persons total labs. Scores range from 0 to 1. Higher scores indicate more unhealthy lab records. | Posted | Mean | Standard Deviation | fraction of unhealthy lab scores | 12-months |
|
|
|
| Secondary | Falls | Falls were assessed by asking how often the participant had fallen in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen. Falls ranged from 0 to 14. | Posted | Mean | Standard Deviation | falls | Baseline and 12-months |
|
|
|
| Secondary | Symptom Distress | Symptom distress is assessed using a combined list of 20 symptoms and chronic conditions from the General Symptom Distress Scale and Bayliss Disease Burden Scale, assessing the severity of distress for each over the past 2 weeks (0=do not have this, 1=not very distressing, and 5=extremely distressing). Scores range from 0 to 100. Higher scores indicate more symptom distress. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-months |
|
|
|
| Secondary | Medication Adherence | Medication adherence is assessed with 8 items, 6 based on the Brief Medication Questionnaire by Svarstad et al. We simplified response options so that participants rate how often they had specific issues with medication (1=never and 5=always). On the basis of patients' experiences, we added 2 original items, "Feels like I no longer need it" and "Feels like I don't need the full dose. There were 8 items in total, summed to get a final score. Scores ranged from 8 to 40. Higher scores indicate less medication adherence. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-months |
|
|
|
| Secondary | Crisis Health Care Visits | Crisis health care was the total number of urgent care visits, emergency room visits, and hospitalizations combined. Reported is the average count of visits. Higher numbers indicate more visits. | Posted | Mean | Standard Deviation | visits | Baseline and 12-months |
|
|
|
| Secondary | Long-term Care | Long-term care was the number of nights spent in assisted living facilities and nursing homes over the past 3 months. Number of nights ranged from 0 to 92. Higher numbers indicate more nights spent. | Posted | Mean | Standard Deviation | nights | Baseline and 12-months |
|
|
|
| Secondary | Falls Requiring Medical Attention | Falls requiring medical attention was assessed by one item counting the number of times in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen and required medical attention. Falls needing medical attention ranged from 0 to 4. | Posted | Mean | Standard Deviation | falls requiring medical attention | Baseline and 12-months |
|
|
|
| 4 |
| 168 |
| 0 |
| 168 |
| 0 |
| 168 |
| EG001 | Treatment as Usual (TAU) + ElderTree | Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician. For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits. | 8 | 176 | 0 | 176 | 0 | 176 |
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| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |