Translation of an Evidence-Based Fall-Prevention Program Into Rural West Virginia Churches

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by West Virginia University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Dina L. Jones, PT, PhD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01961037
First received: September 11, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

Falls are the leading cause of death and injuries in adults over age 65 both nationally and in West Virginia. Rurality, age, physical inactivity, and chronic conditions, such as arthritis, are strong risk factors for falls in this population. West Virginia has a higher than average fall rate, the second oldest population, the greatest proportion of inactive adults, and the second highest prevalence of arthritis in the US. Thus, older adults in rural West Virginia are at high risk for falls and in great need of public health fall prevention programs. The Tai Chi: Moving for Better Balance (MFBB) program is a community-based, fall-prevention exercise program for older adults. A waiver of informed consent will be requested to conduct the telephone screenings to determine study eligibility. We will enroll up to 300 people in classes to be held at 20 churches in West Virginia. Classes will be held twice per week for 16 weeks and taught by certified MFBB instructors. Participants will be interviewed by telephone, have a brief physical function ability exam, and complete a questionnaire before starting the exercise class, at the end of the class, and 4 months later. The study is being conducted to answer the following questions: 1) What are the functional improvements of older adults who participate in a 16-week MFBB program; 2) What is the rate of falls for those adults; 3) What is the rate and severity of those fall-related injuries of the MFBB participants? The purpose of the study is to: 1) implement a 16-week intervention of MFBB with a 16-week follow-up, in older adults in churches in rural West Virginia; 2) describe functional and fall/injury outcomes. Ultimately, we will translate an efficacious and effective fall-prevention intervention into a new setting.


Condition Intervention
Accidental Falls
Other: Tai Chi: Moving for Better Balance

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Translation of an Evidence-Based Fall-Prevention Program Into Rural West Virginia Churches

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • 10-Meter Walk Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed


Secondary Outcome Measures:
  • Number of fall-related injuries [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
    Measure the number of reported fall-related injuries by study participants during the intervention and during the 16-week period after the intervention is complete.

  • Number of falls [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
    Measure the number of reported falls by study participants during the intervention and during the 16-week period after the intervention is complete.


Other Outcome Measures:
  • Four Square Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.

  • Timed Up-And-Go Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The Timed Up-And-Go Test will be used to assess functional mobility. A participant stands from a chair, walks three meters at a self-selected pace, turns, and returns to the chair to sit.

  • Champs Activity Questionnaire for Older Adults [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The CHAMPS Activities Questionnaire for Older Adults will be administered by telephone interview by trained team members to assess the typical weekly frequency and duration of participation in 41 leisure and daily activities during the past month. The CHAMPS has shown superior reliability, validity, and responsiveness over other instruments in trials of fall-injury prevention programs.

  • SF-12 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The SF-12 v2, which is recommended for inclusion in fall/injury prevention trials, will be used to determine physical and mental health-related quality of life.

  • Falls Efficacy Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.

  • Translation of MFBB in the churches with respect to its Reach [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    We will determine the proportion of eligible older adults who participate in a 16-week church-based intervention of MFBB.

  • Translation of MFBB in the churches with respect to its Adoption [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    We will determine the proportion of invited churches that offer MFBB.

  • Translation of MFBB in the churches with respect to its Implementation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    We will determine if MFBB was delivered as intended by its developer.

  • Translation of MFBB in the churches with respect to its Maintenance (churches) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    We will determine the proportion of churches who continue MFBB at 32 weeks.

  • Translation of MFBB in the churches with respect to its Maintenance (participants) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    We will determine the proportion of participants who continue MFBB at 32 weeks.

  • 10-Meter Walk Test [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed.

  • Four Square Test [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.

  • Timed Up-And-Go Test [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    The Timed Up-And-Go Test will be used to assess functional mobility. A participant stands from a chair, walks three meters at a self-selected pace, turns, and returns to the chair to sit.

  • Champs Activity Questionnaire for Older Adults [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    The CHAMPS Activities Questionnaire for Older Adults will be administered by telephone interview by trained team members to assess the typical weekly frequency and duration of participation in 41 leisure and daily activities during the past month. The CHAMPS has shown superior reliability, validity, and responsiveness over other instruments in trials of fall-injury prevention programs.

  • SF-12 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    The SF-12 v2, which is recommended for inclusion in fall/injury prevention trials, will be used to determine physical and mental health-related quality of life.

  • Falls Efficacy Scale [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.


Estimated Enrollment: 300
Study Start Date: February 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity intervention
Tai Chi: Moving for Better Balance exercise program
Other: Tai Chi: Moving for Better Balance
Participants will attend one-hour Tai Chi classes twice weekly for 16 weeks.
Other Names:
  • Tai Chi
  • Exercise
  • Physical Activity

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 55 years or older

Exclusion Criteria:

  • None
  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: NCT01961037

Contacts
Contact: Jennifer L Eicher, BS (855) 314-0742 jeicher@hsc.wvu.edu
Contact: Dina L Jones, PT, PhD 304-293-1078

Locations
United States, West Virginia
Hughes River Presbyterian Church Not yet recruiting
Cairo, West Virginia, United States, 26337
Wesley United Methodist Church Recruiting
Ellenboro, West Virginia, United States, 26346
Harper Memorial Church Not yet recruiting
Gandeeville, West Virginia, United States, 25243
First Baptist Church Not yet recruiting
Grantsville, West Virginia, United States, 26147
First Assembly of God Not yet recruiting
Harrisville, West Virginia, United States, 26362
Cisco Community Church Not yet recruiting
Petroleum, West Virginia, United States, 26161
First Baptist Church Recruiting
Spencer, West Virginia, United States, 25276
Memorial United Methodist Church Recruiting
Spencer, West Virginia, United States, 25276
Spencer Presbyterian Church Recruiting
Spencer, West Virginia, United States, 25276
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Dina L Jones, PT, PhD West Virginia University
  More Information

No publications provided

Responsible Party: Dina L. Jones, PT, PhD, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01961037     History of Changes
Other Study ID Numbers: 5 R49 CE002109-DLJ
Study First Received: September 11, 2013
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Accidental Falls
Tai Chi
Older Adults
Balance
Moving for Better Balance
Church
Congregational Intervention
Rural
West Virginia

ClinicalTrials.gov processed this record on September 18, 2014