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

• ClinicalTrials.gov Identifier: NCT03028493
• Recruitment Status: Completed
• First Posted: January 23, 2017
• Last Update Posted: January 4, 2018
• Sponsor: Sarah Blaylock
• Collaborator: VA Office of Research and Development
• Information provided by (Responsible Party): Sarah Blaylock, University of Alabama at Birmingham

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Low Vision; Fall	Behavioral: Original SAFE Intervention; Behavioral: Adapted SAFE Intervention	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Three individuals not involved in intervention delivery will complete pre-post measures.
• Primary Purpose: Prevention
• Official Title: Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision
• Actual Study Start Date: January 18, 2017
• Actual Primary Completion Date: December 15, 2017
• Actual Study Completion Date: December 15, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Adapted SAFE Intervention; Adapted version of the SAFE Health Behavior and Exercise intervention.	Behavioral: Adapted SAFE Intervention; An adapted version of the SAFE intervention meant to target older adults with low vision.
Active Comparator: Original SAFE Intervention; Original version of the SAFE intervention.	Behavioral: Original SAFE Intervention; A CDC recommended, evidence-based falls prevention intervention.

Outcome Measures

Primary Outcome Measures :

1. Change in knowledge of falls prevention [ Time Frame: Pre and post (2 weeks after start of intervention delivery) ]
   10 multiple choice questions based on the SAFE intervention content

Secondary Outcome Measures :

1. Short Physical Performance Battery [ Time Frame: Pre ]
   Measures of balance, gait, and sit to stand
2. PROMIS Depression Scale [ Time Frame: Pre ]
   Measures depression
3. PROMIS Participation Scale [ Time Frame: Pre ]
   Measures daily participation
4. PROMIS Global Health [ Time Frame: Pre ]
   Measures general health
5. UAB Life-Space Inventory [ Time Frame: Pre ]
   Measures places travelled within past month

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 60 and older;
• Visual impairment with some remaining reading ability.

Exclusion Criteria:

• Less than age 60;
• Complete blindness;
• Vertebral osteoporosis.

Contacts and Locations

Locations

United States, Alabama

Department of Veteran Affairs

Birmingham, Alabama, United States, 35205

Sponsors and Collaborators

Sarah Blaylock

VA Office of Research and Development

Investigators

• Principal Investigator: Cynthia Brown, MD, MSPH; Birmingham VA and UAB School of Medicine

More Information

• Responsible Party: Sarah Blaylock, Doctoral Candidate Department of Occupational Therapy, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03028493
• Other Study ID Numbers: 01633
• First Posted: January 23, 2017
• Last Update Posted: January 4, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: All data serves to fulfill dissertation requirement and will not be shared with additional researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vision, Low; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases