Skip to main content
OpenTrials
Completed

NCT Number: NCT04876729

Standing Strong in Tribal Communities: Assessing Elder Falls Disparity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuni Health Initiative

Zuni Pueblo, New Mexico, 87327, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Otago Exercise Program

Behavioral

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.

Primary outcomes

  1. Changes in Strength and Balance at 3 months, 6 months, and 12 months

    Time frame: 3 months, 6 months and 12 months

    Changes Timed Up and Go, 30 Second Chair Stand, and Four Stage Balance test

Secondary outcomes

  1. Stop Elderly Accidents, Deaths and Injuries (STEADI) Stay Independent is a 12-item assessment

    Time frame: Baseline

    History of falls and other issues related to increased chance of a fall; Scale: 0-14; Higher score indicates greater falls risk

  2. The Attitudes to Falls-Related Interventions Scale (AFRIS)

    Time frame: Baseline and 12 months

    Examines beliefs about falls prevention; Scale: 0-18; Higher score indicates more positive beliefs about falls prevention

  3. Medical Outcomes Study Short Form 12 (SF-12v2)

    Time frame: Baseline, 6 months and 12 months

    12-item questionnaire that tests how health affects quality of life; Scale: 12-47; Higher score indicates better quality of life

  4. Falls incidence

    Time frame: Monthly from baseline to 12 months

    Monthly falls calendar over 12 months

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Daily Activities

    Time frame: Baseline, 6 months and 12 months

    Measures ability to manage daily activities; Scale: 4-20; Higher score indicates greater self-efficacy to manage daily activities

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities

    Time frame: Baseline, 6 months and 12 months

    Measures participation in the community; Scale: 4-20; Higher score indicates more difficulty participating in social roles and activities

  7. Clinical Characteristics

    Time frame: Baseline and 12 months

    Anthropological Measurement (Ht & Wt)

  8. Clinical Characteristics

    Time frame: Baseline, 3 months, 6 months, 12 months

    Blood Pressure

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 6, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.