Multiple Chronic Conditions for Older Adults

Not Applicable

Completed

Conditions: Chronic Disease

Interventions: Behavioral: TAU + ElderTree
Other: Treatment as usual (TAU) + Internet

Registration Number: NCT03387735

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 346

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual (TAU) + ElderTree	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.
Treatment as usual (TAU) + Internet	Treatment as usual (TAU) + Internet	Patients will be given access to helpful websites such as National Institute on Aging.

Primary Outcome Measures

Name	Time	Method
UCLA Loneliness Scale	Baseline and 12-months	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.
PROMIS Global Health Measure Score	Measured at baseline and 12 months	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.
Psychological Flourishing Scale	Baseline and 12-months	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.

Secondary Outcome Measures

Name	Time	Method
Symptom Distress	Baseline and 12-months	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.
Medication Adherence	Baseline and 12-months	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.
Falls	Baseline and 12-months	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 Requiring Medical Attention	Baseline and 12-months	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.
Unhealthy Laboratory Scores	12-months	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.
Long-term Care	Baseline and 12-months	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.
Crisis Health Care Visits	Baseline and 12-months	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.