Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
2 other identifiers
interventional
189
1 country
1
Brief Summary
Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
1 active site
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
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedDecember 30, 2015
December 1, 2015
8 months
March 8, 2012
December 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Falls
Falls ascertained in automated monthly telephone contact
6 months
Secondary Outcomes (1)
Fall-related injuries requiring hospitalization/emergency department care
6 months
Study Arms (3)
Healthy Steps
ACTIVE COMPARATORHealthy Steps program as currently implemented by the PA Department of Aging
Healthy Steps with Falls Case Management
EXPERIMENTALHealthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment
Healthy Steps in Motion
EXPERIMENTALHealthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise.
Interventions
Counseling to ensure that participants receive a physician assessment and home safety check
Eligibility Criteria
You may qualify if:
- Able to provide informed consent
- Willing to be randomized
- Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
- Age 50+
You may not qualify if:
- Hospice enrollee or life-threatening illness
- Active cancer treatment
- Neurologic disease linked to falls risk, such as Parkinson's
- Unable to ambulate indoors
- High likelihood of moving in next 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven M Albert, PhD
University of Pittsburgh
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
- Professor
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 13, 2012
Study Start
May 1, 2012
Primary Completion
January 1, 2013
Study Completion
June 1, 2013
Last Updated
December 30, 2015
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will share
Deidentified research data will be made available to qualified investigators