Elders Preserving Independence in the Community

NCT05381480 | Terminated

• 1 other identifier: STUDY00001884
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Aging

Keywords

Low Income Older Adults

Outcome Measures

Primary Outcomes (3)

• PROMIS 10-item Global Health Scale - Total Score

  Change in Total Score (standardized T-scores average = 50, SD = 10)

  Assessed at baseline, 9-months and 18-months (end of study)

• PROMIS 10-item Global Health Scale - Physical Functioning Subscale

  Change in Physical Functioning subscale (standardized T-scores average = 50, SD = 10)

  Assessed at baseline, 9-months and 18-months (end of study)

• PROMIS 10-item Global Health Scale - Mental Functioning Subscale

  Change in Mental Functioning subscale (standardized T-scores average = 50, SD = 10)

  Assessed at baseline, 9-months and 18-months (end of study)

Secondary Outcomes (10)

• PROMIS Physical Functioning - Short Form 10b

  Assessed at baseline enrollment, 9-months, 18 months (end of study)

• PROMIS Self-Efficacy for Chronic conditions - Managing Daily Activities - Short Form 4a

  Assessed at baseline enrollment, 9-months, 18 months (end of study)

• PROMIS short form for general self-efficacy - Short Form 4a

  Assessed at baseline enrollment, 9-months, 18 months (end of study)

• PROMIS short form for self-efficacy for managing social interactions - Short Form 4a

  Assessed at baseline enrollment, 9-months, 18 months (end of study)

• PROMIS Loneliness and Social Isolation (Ages 18+) fixed form

  Assessed at baseline enrollment, 9-months, 18 months (end of study)

Study Arms (2)

In-home Preventive Health Visits by Advanced Practice Nurse

ACTIVE COMPARATOR

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.

Behavioral: In-home Preventive Health Visits by Advanced Practice Nurse

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

ACTIVE COMPARATOR

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.

Behavioral: On-site Evidence-based Physical Activity, Health and Wellness Classes

Interventions

In-home Preventive Health Visits by Advanced Practice Nurse BEHAVIORAL

Elements of Comprehensive Geriatric Assessment used as a preventive, health risk assessment, with recommendations tailored for health risks identified and offered to building tenants

In-home Preventive Health Visits by Advanced Practice Nurse

On-site Evidence-based Physical Activity, Health and Wellness Classes BEHAVIORAL

Weekly calendar of health promotion and injury/illness prevention classes offered to building tenants.

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and income qualified tenants in 18 identified older adult low income independent living apartment buildings.

You may not qualify if:

• Non-tenants in 18 identified buildings
• Assessed to be cognitively impaired and unable to consent.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• UniHealth Foundation: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Harriet U Aronow, PhD

  Cedars-Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist IV

Model Details: Cluster Randomized Controlled Trial, buildings randomized to one of two interventions

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 19, 2022
• Study Start: November 22, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)