NCT03294447

Brief Summary

Purpose of the study: To identify if an intervention focused on decreasing fear of falling (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has the potential to decrease falls and improve physical, psychological and social factors related to FOF. The primary research question: Is there an association between fear of falling among geriatric populations and fall prevention interventions that are offered by occupational therapist in a geriatric primary care setting?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

May 23, 2017

Last Update Submit

December 11, 2020

Conditions

Keywords

Fear of falling

Outcome Measures

Primary Outcomes (1)

  • The Change of Falls Efficacy Scale-International (FES-I), standardized measure for fear of falling

    The outcome measure is the change between the pre FES-I and post FES-I

    One Time visit: 30-50 minutes

Study Arms (1)

Fall Prevention Intervention by OT

EXPERIMENTAL

Fall prevention interventions implemented by an OT in a geriatric primary care setting for a client immediately following the provider visit within the office.

Behavioral: Fall Prevention by the Occupational Therapist

Interventions

The interventions included education on adaptive equipment for household activities, adaptive equipment for activities of daily living, proper footwear in all environments, proper body mechanics, position changes, home environment set up, high fall risk activities, safety awareness, low vision and home exercises programs. In addition, discussion and education occurred to improve participation in valued occupations.

Fall Prevention Intervention by OT

Eligibility Criteria

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

You may qualify if:

  • cognitively intact with a score of 29/30 or higher on the Orientation Log (standardized assessment tool)
  • living in the community
  • English speaking
  • had a fall or near fall in the past year

You may not qualify if:

  • received OT services within the past 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Primary Care Clinic

Chicago, Illinois, 60612, United States

Location

Study Officials

  • Lydia Royeen, Masters

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Occupational Therapist

Study Record Dates

First Submitted

May 23, 2017

First Posted

September 27, 2017

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations