- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04876729
Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
Zuni Health Initiative- Sub Study - Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vallabh Shah, PhD
- Phone Number: 505-272-9615
- Email: vshah@salud.unm.edu
Study Contact Backup
- Name: Carla Herman, MD
- Phone Number: 505-272-5630
- Email: CHerman@salud.unm.edu
Study Locations
-
-
New Mexico
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Zuni Pueblo, New Mexico, United States, 87327
- Recruiting
- Zuni Health Initiative
-
Contact:
- Vallabh Shah, PhD
- Phone Number: 505-782-2578
- Email: vshah@salud.unm.edu
-
Contact:
- Carla Herman, MD
- Phone Number: 505-782-2578
- Email: CHreman@salud.unm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months, 6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
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
|
Baseline and 12 months
|
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
|
Baseline, 6 months and 12 months
|
Falls incidence
Time Frame: Monthly from baseline to 12 months
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Monthly falls calendar over 12 months
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Monthly from baseline to 12 months
|
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
|
Baseline, 6 months and 12 months
|
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
|
Baseline, 6 months and 12 months
|
Clinical Characteristics
Time Frame: Baseline and 12 months
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Anthropological Measurement (Ht & Wt)
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Baseline and 12 months
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Clinical Characteristics
Time Frame: Baseline, 3 months, 6 months, 12 months
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Blood Pressure
|
Baseline, 3 months, 6 months, 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-261 -Falls study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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