Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision

Fall Clinical Trial

Official title:

Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028493
• Other study ID #: 01633
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: January 2, 2018
• Start date: January 18, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study serves to test a previously evaluated falls prevention intervention recommended by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is accessible to older adults with low vision receiving services from the Southeastern Blind Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE intervention that has been adapted to be accessible for individuals with low vision at SBRC.

Description:

This study serves to compare the comprehension and retention of individuals completing a version of the SAFE falls prevention intervention adapted for low vision versus individuals receiving the original intervention. One group of participants will complete the standard SAFE intervention format while another group will complete the same intervention with written materials adapted for those with vision loss. One intervention (either standard or adapted SAFE program) will be delivered at a time. The SAFE intervention is comprised of four, 90-minute group classes that address environmental, behavioral, and physical falls risk factors. Classes involve lecture and group discussions as well as review of low intensity exercises. The adapted content is presented in large print with high contrast and has been rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts provided feedback to strengthen the adapted intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 and older;

• Visual impairment with some remaining reading ability.

Exclusion Criteria:

• Less than age 60;

• Complete blindness;

• Vertebral osteoporosis.

Related Conditions & MeSH terms

• Fall
• Low Vision
• Vision, Low

Intervention

Behavioral:
• Original SAFE Intervention
A CDC recommended, evidence-based falls prevention intervention.
• Adapted SAFE Intervention
An adapted version of the SAFE intervention meant to target older adults with low vision.

Locations

Country	Name	City	State
United States	Department of Veteran Affairs	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Sarah Blaylock	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knowledge of falls prevention	10 multiple choice questions based on the SAFE intervention content	Pre and post (2 weeks after start of intervention delivery)
Secondary	Short Physical Performance Battery	Measures of balance, gait, and sit to stand	Pre
Secondary	PROMIS Depression Scale	Measures depression	Pre
Secondary	PROMIS Participation Scale	Measures daily participation	Pre
Secondary	PROMIS Global Health	Measures general health	Pre
Secondary	UAB Life-Space Inventory	Measures places travelled within past month	Pre