Nurse-Led Home Visits vs. Wellness Classes for Healthy Aging

(EPIC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Non-tenants, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Twenty percent of the US population will be age 65 or older by 2050, a surge from 8 percent in 1950 and 12 percent in 2000. The proportion of low-income older adults is also growing. Approximately 70 percent of people 65 and older are expected to need some level of long-term care, which may burden the nation's health and caregiver systems. While there are many models to care for chronically ill older adults, there is less agreement on how to support healthier, low-income older adults to stay independent in their communities. This study will compare the effectiveness of an in-home preventive healthcare program delivered by nurses to on-site health and wellness classes for older adults living in low-income independent housing. We also want to understand adherence and preferences of older adults for these two options. The three-year study will take place in up to 18 low-income independent older adult apartment buildings in Los Angeles. Half of buildings will be randomized to offer the health and wellness classes, and the other half will offer the in-home preventive healthcare program. All study activities will be provided on-site at the building locations, and individuals living in the buildings will be invited to participate. A total of 480 participants will be recruited to participate, 240 in each group. Residents from participating buildings will meet with the research team to provide feedback throughout the study. Other stakeholders, including doctors, housing services, social agencies, hospital leaders, professional societies, advocacy groups, and city policymakers will also meet with the team as an advisory group to share input and concerns. This project seeks to compare how each option maintains or improves health and functional independence in low-income older adults, with the goal of limiting dependency, moves to nursing homes, and the use of costly health services, while improving health behaviors and promoting the use of preventive health and appropriate community services.

Who Is on the Research Team?

Harriet U Aronow, PhD

Principal Investigator

Cedars-Sinai Health System

Are You a Good Fit for This Trial?

This trial is for tenants aged 65 or older living in certain low-income independent housing in Los Angeles. Participants must be able to consent, meaning they can't have cognitive impairments that would prevent them from understanding the study.

Inclusion Criteria

I am a senior living in a low-income independent apartment.

Exclusion Criteria

Non-tenants in 18 identified buildings

I am unable to make medical decisions due to cognitive impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Enrollment and Assessment

Baseline enrollment and assessment conducted prior to randomization of buildings

2 weeks

1 visit (in-person)

Intervention

Participants receive either in-home preventive health visits by APRNs or on-site health and wellness classes

18 months

Quarterly follow-up visits for APRN group; Weekly classes for class group

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• In-home Preventive Health Visits by Advanced Practice Nurse
• On-site Evidence-based Physical Activity, Health and Wellness Classes

Trial Overview The study compares two programs: one where nurses visit homes to provide preventive healthcare, and another offering on-site health and wellness classes. The goal is to see which helps maintain or improve health and independence among elders.

How Is the Trial Designed?

Group I: In-home Preventive Health Visits by Advanced Practice Nurse Active Control 1 Intervention

APRNs will perform in-home multidimensional health assessment with quarterly follow up visits to provide individualized patient education, negotiation of recommendations to maintain/improve health and wellness. All participants continue to receive care from their primary care provider and other community-based providers, although use might be modified. Throughout the intervention, participants are encouraged to take a primary role in the management of their own health. APRNs coach and guide the participant in navigating existing service providers as well as accessing and establishing new services. Having the program in-home promotes an atmosphere of shared decision-making, while allowing the nurse to observe the physical and social environment. Key to this model is identification of individual profiles of health strengths and health risks; recommendations and negotiation over priority health behavior change; and quarterly follow up.

Group II: On-site Evidence-based Physical Activity, Health and Wellness Classes Active Control 1 Intervention

Curriculum. There will be three categories of classes offered at sites randomized into this intervention. A physical activity class will be offered three times weekly, and will include elements of Tai Chi, fall prevention, and arthritis exercises. Class content/activity will be modified for all levels of ability. A class focused on mental health and functioning will be offered weekly, and include activities targeting depression prevention, memory enhancement, and engagement (e.g., life review, agile mind). There will also be offered a weekly multi-topic class with a repeating cycle of topics and instructors including medication management, computer literacy and electronic health records, etc.. Tenants will be engaged in choosing topics that reflect the group consensus on importance. Altogether, at each location there will be five scheduled class opportunities each week for tenants to choose among.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

UniHealth Foundation

Collaborator

Trials

2

Recruited

430+