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

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Steven M. Albert, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01552551
First received: March 8, 2012
Last updated: December 29, 2015
Last verified: December 2015
  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
Lower Extremity Weakness Distal
Distorted; Balance
Behavioral: Assessment and education
Behavioral: Healthy Steps with Falls Case Management
Behavioral: Healthy Steps in Motion

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:


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


Enrollment: 189
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: January 2013 (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

Detailed Description:

This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk.

This study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.

  Eligibility

Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552551

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Steven M Albert, PhD University of Pittsburgh
  More Information

Responsible Party: Steven M. Albert, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01552551     History of Changes
Other Study ID Numbers: U48DP002657-RCT 
Study First Received: March 8, 2012
Last Updated: December 29, 2015
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Deidentified research data will be made available to qualified investigators

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

ClinicalTrials.gov processed this record on August 23, 2016