Clinical trial NCT04876729: Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
Official title: Zuni Health Initiative- Sub Study - Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall
Keywords: American Indians
Zuni Indians
Falls Screening
Otago Exercise program (OEP)
STEADI toolkit
Older adult
Falls Prevention
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Strength and Balance at 3 months, 6 months, and 12 months
timeFrame: 3 months, 6 months and 12 months
Secondary outcomes:
measure: Stop Elderly Accidents, Deaths and Injuries (STEADI) Stay Independent is a 12-item assessment
timeFrame: Baseline
measure: The Attitudes to Falls-Related Interventions Scale (AFRIS)
timeFrame: Baseline and 12 months
measure: Medical Outcomes Study Short Form 12 (SF-12v2)
timeFrame: Baseline, 6 months and 12 months
measure: Falls incidence
timeFrame: Monthly from baseline to 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Daily Activities
timeFrame: Baseline, 6 months and 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities
timeFrame: Baseline, 6 months and 12 months
measure: Clinical Characteristics
timeFrame: Baseline and 12 months
measure: Clinical Characteristics
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Zuni Pueblo
country: United States
facility: Zuni Health Initiative
state: New Mexico
Study officials:
References:
citation: 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.