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Standing Strong in Tribal Communities: Assessing Elder Falls Disparity

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ClinicalTrials.gov Identifier: NCT04876729
Recruitment Status : Not yet recruiting
First Posted : May 6, 2021
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Vallabh O Shah, University of New Mexico

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fall Behavioral: Otago Exercise Program Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Zuni Health Initiative- Sub Study - Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Otago Exercise Program
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
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.
No Intervention: Education
The control group will receive education on fall risk reduction. This will be delivered by the CHR with 6 home visits over 12 months


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04876729


Contacts
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Contact: Vallabh Shah, PhD 505-272-9615 vshah@salud.unm.edu
Contact: Carla Herman, MD 505-272-5630 CHerman@salud.unm.edu

Sponsors and Collaborators
University of New Mexico
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Vallabh O Shah, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT04876729    
Other Study ID Numbers: 21-261 -Falls study
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vallabh O Shah, University of New Mexico:
American Indians
Zuni Indians
Falls Screening
Otago Exercise program (OEP)
 STEADI toolkit
Older adult
Falls Prevention