NCT00618800

Brief Summary

The objective of the proposed study is to reduce the incidence of falls and fall-related injuries among community-dwelling older adults by better utilizing community pharmacists to advise patients and physicians on medication management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 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

August 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 19, 2011

Status Verified

September 1, 2011

Enrollment Period

4.1 years

First QC Date

February 7, 2008

Last Update Submit

September 16, 2011

Conditions

Falls

Keywords

FallsElderlyInjuryMedicationPharmacyPharmacist

Outcome Measures

Primary Outcomes (2)

  • Time to first fall

    One Year

  • Proportion of participants who fall

    One Year

Secondary Outcomes (1)

  • Use of high-risk medications

    One Year

Study Arms (2)

Pharmacist Care

EXPERIMENTAL

Pharmacist Intervention

Behavioral: Pharmaceutical Care

Control

ACTIVE COMPARATOR

Written information only group

Other: Written Materials

Interventions

Pharmaceutical CareBEHAVIORAL

Participants receive written information about falls prevention and a personal consultation from a community pharmacist concerning their medication regimen. The pharmacist follows up, as required, with participants' physicians to coordinate any recommended medication changes.

Pharmacist Care
Written MaterialsOTHER

Participants receive written information about falls prevention.

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Currently taking at least four prescription medications
  • Currently taking at least one high risk medication
  • At least one fall during 12 month period before study entry
  • Able to speak and read English

You may not qualify if:

  • Resident of a long-term care facility
  • Cognitive impairment
  • Housebound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Injury Prevention Research Center

Chapel Hill, North Carolina, 27599-7505, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Pharmaceutical Services

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Susan J. Blalock, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 20, 2008

Study Start

August 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2009

Last Updated

September 19, 2011

Record last verified: 2011-09

Locations

US(1)