NCT03028493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

January 18, 2017

Last Update Submit

January 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Short Physical Performance Battery

    Pre

  • PROMIS Depression Scale

    Pre

  • PROMIS Participation Scale

    Pre

  • PROMIS Global Health

    Pre

  • UAB Life-Space Inventory

    Pre

Study Arms (2)

Adapted SAFE Intervention

EXPERIMENTAL

Adapted version of the SAFE Health Behavior and Exercise intervention.

Behavioral: Adapted SAFE Intervention

Original SAFE Intervention

ACTIVE COMPARATOR

Original version of the SAFE intervention.

Behavioral: Original SAFE Intervention

Interventions

A CDC recommended, evidence-based falls prevention intervention.

Original SAFE Intervention

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

Adapted SAFE Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Veteran Affairs

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia Brown, MD, MSPH

    Birmingham VA and UAB School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Three individuals not involved in intervention delivery will complete pre-post measures.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Candidate Department of Occupational Therapy

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 23, 2017

Study Start

January 18, 2017

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

January 4, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

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

Locations