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Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program

This study is currently recruiting participants.
Verified March 2012 by University of Pittsburgh
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01552551
First received: March 8, 2012
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Lower Extremity Weakness
Balance Problems
 Behavioral: Assessment and education
Behavioral: Healthy Steps with Falls Case Management
Behavioral: Healthy Steps in Motion
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Falls [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Falls ascertained in automated monthly telephone contact


Secondary Outcome Measures:
  • Fall-related injuries requiring hospitalization/emergency department care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Events ascertained in a monthly automated telephone interview


Estimated Enrollment: 180
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Steps
Healthy Steps program as currently implemented by the PA Department of Aging
 Behavioral: Assessment and education
PA Healthy Steps program
Experimental: Healthy Steps with Falls Case Management
Healthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment
 Behavioral: Healthy Steps with Falls Case Management
Counseling to ensure that participants receive a physician assessment and home safety check
Experimental: Healthy Steps in Motion
Healthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise.
 Behavioral: Healthy Steps in Motion
Group exercise program

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to provide informed consent
  2. Willing to be randomized
  3. Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
  4. Age 50+

Exclusion Criteria:

  1. Hospice enrollee or life-threatening illness
  2. Active cancer treatment
  3. Neurologic disease linked to falls risk, such as Parkinson's
  4. Unable to ambulate indoors
  5. High likelihood of moving in next 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552551

Contacts
Contact: Jennifer King, BA 412-383-8630 jenking@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Jennifer King, BA     412-383-8630     jenking@pitt.edu    
Principal Investigator: Steven M Albert, PhD            
Sponsors and Collaborators
University of Pittsburgh
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Steven M Albert, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01552551     History of Changes
Other Study ID Numbers: U48DP002657-RCT
Study First Received: March 8, 2012
Last Updated: March 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Falls
exercise
safety
injury
Older adults

Additional relevant MeSH terms:
Asthenia
Muscle Weakness
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013