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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT01552551

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

189

Enrollment

Location

Arms

Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Extremity Weakness Distal Distorted; Balance	Behavioral: Assessment and education Behavioral: Healthy Steps with Falls Case Management Behavioral: Healthy Steps in Motion	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

189 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Falls [6 months]
Falls ascertained in automated monthly telephone contact

Secondary Outcome Measures

Fall-related injuries requiring hospitalization/emergency department care [6 months]
Events ascertained in a monthly automated telephone interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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+

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven M. Albert, Professor, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01552551

Other Study ID Numbers:

U48DP002657-RCT
U48DP002657

First Posted:

Mar 13, 2012

Last Update Posted:

Dec 30, 2015

Last Verified:

Dec 1, 2015

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Steven M. Albert, Professor, University of Pittsburgh

Study Results

No Results Posted as of Dec 30, 2015