An interventional study of Treatment as usual (TAU) + Internet and TAU + ElderTree in Chronic Disease, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care
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.
781 studies on the registry are indexed under Chronic Disease; 144 are open to participants now.
This study's enrollment of 346 is above the median of 140 across 582 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →University of Wisconsin, Madison is the lead sponsor of 1,189 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Compared within Chronic Disease, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria:
be willing to share health-related study data and
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be given access to helpful websites such as National Institute on Aging.
Other: Treatment as usual (TAU) + Internet
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.
Behavioral: TAU + ElderTree
Patients in this group will receive TAU+internet and links to helpful websites.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12-months
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.
Time frame: 12-months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12-months
Recruitment was conducted from January 2018 to December 2019. The intervention period ended in June 2021.
| Milestone | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Started | 168 | 176 |
| Completed | 160 | 160 |
| Not completed | 8 | 16 |
| Withdrew: Lost to follow-up | 4 | 8 |
| Withdrew: Death | 4 | 8 |
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.
| T-score | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline: Mental | 46.27 ± 7.42 | 46.21 ± 7.16 |
| 12 Months: Mental | 44.92 ± 6.82 | 46.38 ± 7.34 |
| Baseline: Physical | 42.40 ± 6.50 | 42.35 ± 5.99 |
| 12 Months: Physical | 42.13 ± 6.30 | 42.41 ± 6.32 |
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.
| score on a scale | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 31.55 ± 5.39 | 31.12 ± 5.08 |
| 12-months | 31.50 ± 5.15 | 31.48 ± 5.60 |
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.
| score on a scale | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 16.02 ± 5.77 | 17.12 ± 6.04 |
| 12-months | 16.05 ± 6.27 | 16.75 ± 5.86 |
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.
| fraction of unhealthy lab scores | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Unhealthy Laboratory Scores | 0.64 ± 0.31 | 0.64 ± 0.34 |
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.
| falls | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 0.36 ± 0.95 | 0.36 ± 0.88 |
| 12-months | 0.36 ± 0.89 | 0.72 ± 4.09 |
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.
| score on a scale | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 21.10 ± 14.56 | 20.58 ± 14.55 |
| 12-months | 18.86 ± 14.89 | 18.58 ± 14.14 |
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.
| score on a scale | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 13.14 ± 4.36 | 13.07 ± 3.88 |
| 12-months | 12.70 ± 4.23 | 12.56 ± 4.07 |
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.
| visits | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 0.42 ± 0.90 | 0.45 ± 1.06 |
| 12-months | 0.86 ± 1.76 | 0.76 ± 1.45 |
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.
| nights | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 0.01 ± 0.15 | 0.25 ± 2.50 |
| 12-months | 0.79 ± 7.76 | 0.29 ± 2.11 |
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.
| falls requiring medical attention | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree |
|---|---|---|
| Baseline | 0.23 ± 0.50 | 0.18 ± 0.39 |
| 12-months | 0.33 ± 0.84 | 0.16 ± 0.37 |
Collected over up to 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment as Usual (TAU) + Internet | 4/168 (2.4%) | 0/168 (0%) | 0/168 (0%) |
| Treatment as Usual (TAU) + ElderTree | 8/176 (4.5%) | 0/176 (0%) | 0/176 (0%) |
| Age, Continuous(years) | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree | Total |
|---|---|---|---|
| Mean | 74.54 ± 6.45 | 75.03 ± 6.27 | 74.79 ± 6.36 |
| Sex: Female, Male(Participants) | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree | Total |
|---|---|---|---|
| Female | 103 | 106 | 209 |
| Male | 65 | 70 | 135 |
| Ethnicity (NIH/OMB)(Participants) | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 167 | 176 | 343 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 8 | 22 |
| White | 153 | 164 | 317 |
| More than one race | 1 | 4 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree | Total |
|---|---|---|---|
| United States | 168 | 176 | 344 |
| Health Insurance type(Participants) | Treatment as Usual (TAU) + Internet | Treatment as Usual (TAU) + ElderTree | Total |
|---|---|---|---|
| Medicare | 57 | 69 | 126 |
| Medicaid | 2 | 1 | 3 |
| Affordable Care Act | 0 | 0 | 0 |
| Military | 0 | 0 | 0 |
| Private insurance | 3 | 2 | 5 |
| Covered under someone else | 0 | 0 | 0 |
| No insurance | 0 | 0 | 0 |
| NA | 1 | 1 | 2 |
| More than one source | 105 | 103 | 208 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2021, 41 months.
Results were first posted in Sep 2022, 1 year 2 months after primary completion.
Of 318 non-industry interventional studies with no phase under Chronic Disease, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 33. This study's 41 months is above that.
Counting every sponsor, half of 328 studies reached it within 21 months; a quarter within 11 and three quarters within 33.
Chronic Disease covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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