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?

This trial explores the best way to help low-income older adults remain healthy and independent. It compares two approaches: in-home preventive health visits by an advanced practice nurse and on-site evidence-based physical activity, health, and wellness classes. The goal is to determine which method better supports health and independence, reducing the need for nursing homes and costly medical care. Residents of designated low-income senior apartment buildings in Los Angeles who are not cognitively impaired may qualify to participate. As an unphased trial, this study offers participants the chance to contribute to important research that could improve the quality of life for seniors.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown positive results from home visits by advanced practice nurses. These visits typically include health check-ups, education, and personalized care plans. Research indicates that such visits can improve quality of life and reduce falls and sudden health problems, suggesting they are generally safe and well-received by older adults.

Studies have also found on-site health and wellness classes to be effective. Exercise classes have been linked to better balance, strength, and flexibility, and they appear to lower the risk of falls and reduce feelings of depression. This indicates that these classes are safe and beneficial for older adults.

Both approaches have strong evidence supporting their safety and positive impact on health, making them good options for older adults who want to stay independent. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative approaches to healthy aging: nurse-led home visits and on-site wellness classes. Unlike typical clinic visits, in-home visits by advanced practice nurses offer personalized care and the chance to observe and address health needs in the patient's own environment, promoting shared decision-making. Meanwhile, the wellness classes provide a comprehensive approach, blending physical activity, mental health support, and practical skills like medication management, all tailored to individual abilities and preferences. This trial aims to find out which method better supports healthy aging, potentially transforming how we approach elder care.

What evidence suggests that this trial's treatments could be effective for healthy aging?

This trial will compare two approaches for healthy aging: in-home preventive health visits by advanced practice nurses and on-site evidence-based physical activity, health, and wellness classes. Studies have shown that when advanced practice nurses visit older adults at home for preventive health check-ups, their health and quality of life can improve. These visits often lead to better health and reduced need for medical services by providing personalized care and advice. Research indicates that these visits help manage health risks and promote healthy habits.

Meanwhile, physical activity and wellness classes based on scientific evidence can enhance physical abilities like balance, strength, and movement in older adults. Programs such as Enhance®Fitness have effectively supported older adults through group exercises and activities that prevent falls. These classes work best when tailored to the interests and needs of the participants. ^{2 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11216600/

The effectiveness of preventive home visits on resilience and ... This research aimed to assess the effectiveness of preventive home visits (PHVs) in enhancing resilience and health-related outcomes among older adults living ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7380935/

The outcomes of nurse practitioner (NP)-Provided home visits The purpose of this study was to systematically examine the current state of the evidence on health and healthcare utilization outcomes associated with NP-home ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666142X21000163

The effectiveness of the role of advanced nurse ... The evidence of this review supports the positive impact of advanced nurse practitioners on clinical and service-related outcomes.

4. researchgate.net researchgate.net/publication/230062862_Stay_Well_and_Healthy_Pilot_Study_Findings_from_an_Inhome_Preventive_Healthcare_Programme_for_Persons_Ageing_with_Intellectual_andor_Developmental_Disabilities

Stay Well and Healthy! Pilot Study Findings from an ... Outcome data on health risks were assessed from information collected using the 'Stay Well and Healthy!' HRA that was administered by a ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23194103/

Effects of an advanced practice nurse in-home ... Objectives: To evaluate the effects of an advanced practice nurse (APN) in-home health consultation program (HCP) on quality of life, health indicators (falls, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9175775/

Home-based primary care visits by nurse practitioners This review synthesizes research on NP home visits for continuous, comprehensive, non-specialized care, including history-taking, physical exams, and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723021127

Article Involvement of Advanced Practice Nurse in the ... The aim of this paper is to explain the need for advanced practice nurses to manage geriatric conditions.

8. researchgate.net researchgate.net/publication/233802979_Effects_of_an_Advanced_Practice_Nurse_In-Home_Health_Consultation_Program_for_Community-Dwelling_Persons_Aged_80_and_Older

Effects of an Advanced Practice Nurse In-Home Health ... Measurements: The primary outcome was quality of life at 3, 6, and 9 months. Secondary outcomes were incidence of falls, acute events due to health problems, ...

9. scholarlycommons.hcahealthcare.com scholarlycommons.hcahealthcare.com/cgi/viewcontent.cgi?article=1900&context=hcahealthcarejournal

Making the Case for Advanced Practice-Sensitive Quality ... APRN-sensitive outcome indicators measure the impact of APRNs' care on patient outcomes and quality, and are crucial for performance evaluation.