Standing Strong in Tribal Communities: Assessing Elder Falls Disparity

NCT04876729 | Completed

• 1 other identifier: 21-261 -Falls study
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fall

Keywords

American Indians; Zuni Indians; Falls Screening; Otago Exercise program (OEP); STEADI toolkit; Older adult; Falls Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Baseline

• The Attitudes to Falls-Related Interventions Scale (AFRIS)

  Baseline and 12 months

• Medical Outcomes Study Short Form 12 (SF-12v2)

  Baseline, 6 months and 12 months

• Falls incidence

  Monthly from baseline to 12 months

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

  Baseline, 6 months and 12 months

Study Arms (2)

Otago Exercise Program

EXPERIMENTAL

An individualized Otago Exercise Program will be delivered by community health representatives (CHR) in participants homes. There will be 10 home visits over a 12 month period.

Behavioral: Otago Exercise Program

Education

NO INTERVENTION

The control group will receive education on fall risk reduction. This will be delivered by the CHR with 6 home visits over 12 months

Interventions

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.

Otago Exercise Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Zuni Health Initiative

Zuni Pueblo, New Mexico, 87327, United States

Location

Related Publications (1)

• Waters DL, Popp J, Herman C, Ghahate D, Bobelu J, Pankratz VS, Shah VO. The Otago Exercise Program compared to falls prevention education in Zuni elders: a randomized controlled trial. BMC Geriatr. 2022 Aug 9;22(1):652. doi: 10.1186/s12877-022-03335-6.

  PMID: 35945496 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: August 16, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)