On-site Evidence-based Physical Activity, Health and Wellness Classes for Healthy Aging

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cedars-Sinai Medical Center, Los Angeles, CA
Healthy Aging
In-home Preventive Health Visits by Advanced Practice Nurse - Behavioral
Eligibility
Any Age
All Sexes
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Study Summary

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.

Treatment Effectiveness

Study Objectives

3 Primary · 14 Secondary · Reporting Duration: Assessed at baseline, 9-months and 18-months (end of study)

Month 18
Health Services Use - Self Report N ED Visits in past 9 months
Health Services Use - Self Report of N SNF/Nursing Home/Rehab Admissions
Health Services Use - Self Report of N of Hospital Admissions
Health Services Use - Self Report of Number of ED Visits in past 9 months
Health Services Use - Self Report of Number of Hospital Admissions
Health Services Use - Self Report of Number of SNF/Nursing Home/Rehab Admissions
PROMIS Loneliness and Social Isolation (Ages 18+) fixed form
PROMIS Physical Functioning - Short Form 10b
PROMIS Self-Efficacy for Chronic conditions - Managing Daily Activities - Short Form 4a
PROMIS Social Isolation - Short Form 4a
PROMIS short form for general self-efficacy - Short Form 4a
PROMIS short form for self-efficacy for managing social interactions - Short Form 4a
Self Report of N of Injury Falls in past 9 months
Self Report of Number of Injury Falls in past 9 months
Assessed at baseline, 9-months and 18-months (end of study)
PROMIS 10-item Global Health Scale - Mental Functioning Subscale
PROMIS 10-item Global Health Scale - Physical Functioning Subscale
PROMIS 10-item Global Health Scale - Total Score

Trial Safety

Trial Design

2 Treatment Groups

On-site Evidence-based Physical Activity, Health and Wellness Classes
1 of 2
In-home Preventive Health Visits by Advanced Practice Nurse
1 of 2
Active Control

640 Total Participants · 2 Treatment Groups

Primary Treatment: On-site Evidence-based Physical Activity, Health and Wellness Classes · No Placebo Group · N/A

On-site Evidence-based Physical Activity, Health and Wellness Classes
Behavioral
ActiveComparator Group · 1 Intervention: On-site Evidence-based Physical Activity, Health and Wellness Classes · Intervention Types: Behavioral
In-home Preventive Health Visits by Advanced Practice Nurse
Behavioral
ActiveComparator Group · 1 Intervention: In-home Preventive Health Visits by Advanced Practice Nurse · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at baseline, 9-months and 18-months (end of study)
Closest Location: Cedars-Sinai Medical Center · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2006First Recorded Clinical Trial
2 TrialsResearching Healthy Aging
515 CompletedClinical Trials

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
449 Previous Clinical Trials
143,681 Total Patients Enrolled
1 Trials studying Healthy Aging
1,000 Patients Enrolled for Healthy Aging
Patient-Centered Outcomes Research InstituteOTHER
488 Previous Clinical Trials
29,866,145 Total Patients Enrolled
UniHealth FoundationUNKNOWN
1 Previous Clinical Trials
330 Total Patients Enrolled
Harriet U Aronow, PhDPrincipal InvestigatorCedars-Sinai Health System

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.