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

Primary Purpose

Low Vision, Fall

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Original SAFE Intervention

Adapted SAFE Intervention

About this trial

This is an interventional prevention trial for Low Vision

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Less than age 60;
Complete blindness;
Vertebral osteoporosis.

Sites / Locations

Department of Veteran Affairs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adapted SAFE Intervention

Original SAFE Intervention

Arm Description

Adapted version of the SAFE Health Behavior and Exercise intervention.

Original version of the SAFE intervention.

Outcomes

Primary Outcome Measures

Change in knowledge of falls prevention

10 multiple choice questions based on the SAFE intervention content

Secondary Outcome Measures

Short Physical Performance Battery

Measures of balance, gait, and sit to stand

PROMIS Depression Scale

Measures depression

PROMIS Participation Scale

Measures daily participation

PROMIS Global Health

Measures general health

UAB Life-Space Inventory

Measures places travelled within past month

Full Information

NCT ID

NCT03028493

First Posted

January 18, 2017

Last Updated

January 2, 2018

Sponsor

Sarah Blaylock

Collaborators

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT03028493

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 18, 2017 (Actual)

Primary Completion Date

December 15, 2017 (Actual)

Study Completion Date

December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sarah Blaylock

Collaborators

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Vision, Fall

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

Outcomes Assessor

Masking Description

Three individuals not involved in intervention delivery will complete pre-post measures.

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adapted SAFE Intervention

Arm Type

Experimental

Arm Description

Adapted version of the SAFE Health Behavior and Exercise intervention.

Arm Title

Original SAFE Intervention

Arm Type

Active Comparator

Arm Description

Original version of the SAFE intervention.

Intervention Type

Behavioral

Intervention Name(s)

Original SAFE Intervention

Intervention Description

A CDC recommended, evidence-based falls prevention intervention.

Intervention Type

Behavioral

Intervention Name(s)

Adapted SAFE Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in knowledge of falls prevention

Description

10 multiple choice questions based on the SAFE intervention content

Time Frame

Pre and post (2 weeks after start of intervention delivery)

Secondary Outcome Measure Information:

Title

Short Physical Performance Battery

Description

Measures of balance, gait, and sit to stand

Time Frame

Pre

Title

PROMIS Depression Scale

Description

Measures depression

Time Frame

Pre

Title

PROMIS Participation Scale

Description

Measures daily participation

Time Frame

Pre

Title

PROMIS Global Health

Description

Measures general health

Time Frame

Pre

Title

UAB Life-Space Inventory

Description

Measures places travelled within past month

Time Frame

Pre

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 60 and older; Visual impairment with some remaining reading ability. Exclusion Criteria: Less than age 60; Complete blindness; Vertebral osteoporosis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cynthia Brown, MD, MSPH

Organizational Affiliation

Birmingham VA and UAB School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Veteran Affairs

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

All data serves to fulfill dissertation requirement and will not be shared with additional researchers.

Learn more about this trial

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

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