Clinical trial NCT03387735: Multiple Chronic Conditions for Older Adults
Official title: Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-01-02
Enrollment: 346
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. are ≥65 years old
2. 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
3. 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
4. report no current psychotic disorder that would prevent participation
5. have no acute medical problem requiring immediate hospitalization
6. be able to read and sign the consent form in English
7. have no known terminal illness
8. 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
9. allow researchers to share information with their primary care physician

Primary outcomes:
measure: PROMIS Global Health Measure Score
timeFrame: Measured at baseline and 12 months
measure: Psychological Flourishing Scale
timeFrame: Baseline and 12-months
measure: UCLA Loneliness Scale
timeFrame: Baseline and 12-months
Secondary outcomes:
measure: Unhealthy Laboratory Scores
timeFrame: 12-months
measure: Falls
timeFrame: Baseline and 12-months
measure: Symptom Distress
timeFrame: Baseline and 12-months
measure: Medication Adherence
timeFrame: Baseline and 12-months
measure: Crisis Health Care Visits
timeFrame: Baseline and 12-months
measure: Long-term Care
timeFrame: Baseline and 12-months
measure: Falls Requiring Medical Attention
timeFrame: Baseline and 12-months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David H Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.