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OpenTrials
Completed

NCT Number: NCT03028493

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Veteran Affairs

Birmingham, Alabama, 35205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Original SAFE Intervention

Behavioral

A CDC recommended, evidence-based falls prevention intervention.

Adapted SAFE Intervention

Behavioral

An adapted version of the SAFE intervention meant to target older adults with low vision.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sarah Blaylock

Other

Collaborators

  • VA Office of Research and Development

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2017
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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