Standing Strong in Tribal Communities: Assessing Elder Falls Disparity

Fall Clinical Trial

Official title:

Zuni Health Initiative- Sub Study - Standing Strong in Tribal Communities: Assessing Elder Falls Disparity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04876729
• Other study ID #: 21-261 -Falls study
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: University of New Mexico
• Contact: Vallabh Shah, PhD
• Phone: 505-272-9615
• Email: vshah[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Falls and fall-related injuries are major health risks in American Indian elders. The data showed 52 percent of Zuni elders reporting a fall during the past year, which is significantly higher than the US national average of one out of three adults older then 65 years. In partnership with Zuni Pueblo leadership and community stake holders, the feasibility will be reviewed in hopes of implementing Community Health Representative delivered fall risk screening and evidence-based Otago Exercise Program with physical therapist consultation to address lack of access to home delivered physical therapy and health disparity, as well as empower the participants to address fall risk, avert injury, and preserve aging in place within their community.

Description:

Native elders are essential to preserving the culture and history of tribal communities, but fall related injuries can jeopardize their ability to age in place. The Zuni Pueblo is geographically isolated with limited access to rehabilitative and supportive services. Home health physical therapy services are unavailable at the Pueblo. Therefore, Zuni elders must choose between leaving their community and social network for rehabilitative care or remain in the community with unmet needs, and increased risk of not regaining their prior level of function.

This study proposes to culturally tailor the traditional Physical Therapy delivered Otago Exercise Program, to evaluate its effectiveness in reducing falls risk and to empower elders and their families to engage in preventing falls in their community. Native Zuni CHRs will deliver OEP using novel consultation and telehealth with a Physical Therapist. The CHRs offer important advantage of speaking Zuni tribal language and understanding Zuni traditions, family structures, and elders' preferences for receiving health information. The investigators overall objective is to compare the effectiveness of a CHR delivered, culturally adapted OEP fall prevention program to the standard of care education based fall risk management.

The investigators disparity driven aims are:

Aim: To compare the effectiveness of the adapted OEP to an education-based fall risk management usual care program in improving strength and balance and reducing falls risk. Approach: Screen 400 Zuni elders, aged 65yrs and older, to identify 200 elders with elevated fall risk. Randomize 200 Zuni elders at risk for falls into a 6-month OEP intervention versus education-based control; Aim: To compare the effectiveness of the adapted OEP to an education-based fall risk management program in improving overall health status, self-management of daily activities, and social engagement. Approach: The SF12 Health Survey and Short Form PROMIS measures Self-Efficacy for Managing Daily Activities and Ability to Participate in Social Roles and Activities will be administered to all randomized participants, at baseline and 6 months, and during the final follow up visit at 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Zuni tribal members aged 65 years and older who demonstrate elevated fall risk according to 2 or more of the following test outcomes: (1) Timed Up and Go >12 seconds; (2) 30 Second Chair Stand Test below age and gender norms; (3) Inability to complete the Four Stage Balance Test; (4) Four or more positive responses on the CDC Stay Independent: Check Your Risk for Falling; or (5) history of 2 or more falls during past year or one injurious fall during past year

Exclusion Criteria:

(1)Self-reported diagnosis of terminal cancer in the last 6 months; (2) Currently on dialysis; (3) Mini-Cog score of 0 to 1; (4) Unwillingness to consent to participate; (5) Unable to walk with or without an assistive device; or (6) Legally blind.

Related Conditions & MeSH terms

• Fall

Intervention

Behavioral:
• Otago Exercise Program
Otago Exercise program implemented including education on fall risk reduction, instruction on strength and balance exercises and walking program. Perform a home safety assessment and provide recommendations to reduce trip hazards. CHRs will engage local housing authority services to complete the modifications (such as grab bar installation). CHRs will complete approximately 10 home visits during 12 months with reassessment at 3, 6, and 12 months.

Locations

Country	Name	City	State
United States	Zuni Health Initiative	Zuni Pueblo	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Strength and Balance at 3 months, 6 months, and 12 months	Changes Timed Up and Go, 30 Second Chair Stand, and Four Stage Balance test	3 months, 6 months and 12 months
Secondary	Stop Elderly Accidents, Deaths and Injuries (STEADI) Stay Independent is a 12-item assessment	History of falls and other issues related to increased chance of a fall; Scale: 0-14; Higher score indicates greater falls risk	Baseline
Secondary	The Attitudes to Falls-Related Interventions Scale (AFRIS)	Examines beliefs about falls prevention; Scale: 0-18; Higher score indicates more positive beliefs about falls prevention	Baseline and 12 months
Secondary	Medical Outcomes Study Short Form 12 (SF-12v2)	12-item questionnaire that tests how health affects quality of life; Scale: 12-47; Higher score indicates better quality of life	Baseline, 6 months and 12 months
Secondary	Falls incidence	Monthly falls calendar over 12 months	Monthly from baseline to 12 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Daily Activities	Measures ability to manage daily activities; Scale: 4-20; Higher score indicates greater self-efficacy to manage daily activities	Baseline, 6 months and 12 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities	Measures participation in the community; Scale: 4-20; Higher score indicates more difficulty participating in social roles and activities	Baseline, 6 months and 12 months
Secondary	Clinical Characteristics	Anthropological Measurement (Ht & Wt)	Baseline and 12 months
Secondary	Clinical Characteristics	Blood Pressure	Baseline, 3 months, 6 months, 12 months