GAPcare Fall Prevention Pilot Survey | NCT03076593

Studies
GAPcare Fall Prevention Pilot Survey

NCT03076593

Sponsor

Rhode Island Hospital

Status

Completed

Last Update Posted

Sep 27, 2021Actual

Enrollment

82Actual

Phase

Not provided

Conditions

Fall

Interventions

Exposure: Fall

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2017Actual

Primary Completion Date

May 30, 2017Actual

Completion Date

Apr 1, 2018Actual

First Submitted Date

Mar 2, 2017

First Submission Date that Met QC Criteria

Mar 6, 2017

First Posted Date

Mar 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that surveys older adults who present to the Emergency Department for any illness to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults. In this observational study, older adults will be approached during routine clinical care in the ED and asked about prior falls, prior experiences having falls treated in the inpatient and outpatient setting, and the investigators will solicit feedback on potential improvement to care in the ED setting for falls.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Name	Type	Description	Arm Group Labels	Other Names
Exposure: Fall	Other	Participants will be asked about prior falls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of enrollment	The investigators will assess the number of patients who were screened and enrolled at the study site	at study enrollment

Secondary Outcomes

Measure	Description	Time Frame
Type of preventative services offered after a prior fall	Participant will be asked what services they were provided after prior falls.	at study enrollment
Satisfaction with prior Emergency Department evaluations after a fall using a likert scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Study inclusion criteria for GAPcare

Adult 65 years-old or older
Able to communicate in English
No cognitive impairment (≥4 on SIS)

Exclusion criteria

• Unable to give informed consent due to intoxication or altered mental status

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Older adults presenting to the Emergency Department at Rhode Island Hospital for any indication

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth M Goldberg, MD	Rhode Island Hospital, Brown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital		Providence	Rhode Island	02903	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided