Multiple Chronic Conditions for Older Adults

Overview

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.

Full Title of Study: “Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 29, 2021

Interventions

  • Other: Treatment as usual (TAU) + Internet
    • Patients in this group will receive TAU+internet and links to helpful websites.
  • Behavioral: 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Treatment as usual (TAU) + Internet
    • Patients will be given access to helpful websites such as National Institute on Aging.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Health outcomes
    • Time Frame: up to 18 months
    • The investigator’s hypothesis is that participants assigned to TAU+ElderTree will have better quality of life than those assigned to TAU+Internet. The investigators will be measuring the quality of life using PROMIS Global Health (10) SF to see if there are any changes to the quality of life reported in the baseline survey, 6, 12, 18 month follow-up surveys.
  • Healthcare use
    • Time Frame: up to 18 months
    • The investigator’s hypothesis is that participants assigned to TAU+ElderTree will have less primary care use (fewer visits) than those assigned to TAU+Internet. The investigators will be measuring the use of health services to see if there are any changes to their visits to primary care clinic, emergency room, urgent care clinic and specialty care visits as reported in the baseline survey, 6, 12, 18 month follow-up surveys.

Secondary Measures

  • Chronic condition outcome: Hypertension
    • Time Frame: 18 months
    • The investigator’s hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as hypertension than participants assigned to TAU+Internet. The investigators will look at the hypertension level using a data pull from the participants’ medical records to see if there are any changes in their millimeters of mercury (mm Hg).
  • Chronic condition outcome: Hyperlipidemia
    • Time Frame: 18 months
    • The investigator’s hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as hyperlipidemia (LDL) than participants assigned to TAU+Internet. The investigators will be looking at the LDL level using a data pull from the participants’ medical records to see if there are any changes in their LDL (bad cholesterol) in their blood.
  • Chronic condition outcome: HbA1c for diabetes
    • Time Frame: 18 months
    • The investigator’s hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as HbA1c than participants assigned to TAU+Internet. The investigators will be looking at the HbA1c level using a data pull from the participants’ medical records to see if there are any changes in their HbA1c level.
  • Chronic condition outcome: Pain
    • Time Frame: 18 months
    • The investigator’s hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as arthritis pain than participants assigned to TAU+Internet. The investigators will be looking at the pain score using a data pull from the participants’ medical records to see if there are any changes in their pain level.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Collaborator
    • Medical University of South Carolina
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David H Gustafson, PhD, Principal Investigator, University of Wisconsin, Madison

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.