Multiple Chronic Conditions for Older Adults

Study Overview
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Brief Summary
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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.

Official Title
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Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology

Conditions
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Chronic Disease

Intervention / Treatment
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* Other: Treatment as usual (TAU) + Internet
* Behavioral: TAU + ElderTree


Participation Criteria
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Eligibility Criteria
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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 Systolic and diastolic BP Weight BMI HDL/LDL HbA1C pain score lung function health care utilization: number of ER visits, urgent care visits, primary care visits and specialty care visits allow researchers to share information with their primary care physician

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Treatment as usual (TAU) + Internet<br>Patients will be given access to helpful websites such as National Institute on Aging. | Other: Treatment as usual (TAU) + Internet<br>* Patients in this group will receive TAU+internet and links to helpful websites.<br>|
| Experimental: Treatment as usual (TAU) + ElderTree<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity