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

December 22, 2015 updated by: Dina L Jones, PT, PhD, West Virginia University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Cairo, West Virginia, United States, 26337
        • Hughes River Presbyterian Church
      • Ellenboro, West Virginia, United States, 26346
        • Wesley United Methodist Church
      • Gandeeville, West Virginia, United States, 25243
        • Harper Memorial Church
      • Grantsville, West Virginia, United States, 26147
        • First Baptist Church
      • Harrisville, West Virginia, United States, 26362
        • First Assembly of God
      • Petroleum, West Virginia, United States, 26161
        • Cisco Community Church
      • Spencer, West Virginia, United States, 25276
        • First Baptist Church
      • Spencer, West Virginia, United States, 25276
        • Memorial United Methodist Church
      • Spencer, West Virginia, United States, 25276
        • Spencer Presbyterian Church

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 55 years or older

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Exercise
  • Tai Chi
  • Physical Activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
10-Meter Walk Test
Time Frame: 16 weeks
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of fall-related injuries
Time Frame: 32 weeks
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.
32 weeks
Number of falls
Time Frame: 32 weeks
Measure the number of reported falls by study participants during the intervention and during the 16-week period after the intervention is complete.
32 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Four Square Test
Time Frame: 16 weeks
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.
16 weeks
Timed Up-And-Go Test
Time Frame: 16 weeks
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.
16 weeks
Champs Activity Questionnaire for Older Adults
Time Frame: 16 weeks
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.
16 weeks
SF-12
Time Frame: 16 weeks
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.
16 weeks
Falls Efficacy Scale
Time Frame: 16 weeks
The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.
16 weeks
Translation of MFBB in the churches with respect to its Reach
Time Frame: 16 weeks
We will determine the proportion of eligible older adults who participate in a 16-week church-based intervention of MFBB.
16 weeks
Translation of MFBB in the churches with respect to its Adoption
Time Frame: 16 weeks
We will determine the proportion of invited churches that offer MFBB.
16 weeks
Translation of MFBB in the churches with respect to its Implementation
Time Frame: 16 weeks
We will determine if MFBB was delivered as intended by its developer.
16 weeks
Translation of MFBB in the churches with respect to its Maintenance (churches)
Time Frame: 32 weeks
We will determine the proportion of churches who continue MFBB at 32 weeks.
32 weeks
Translation of MFBB in the churches with respect to its Maintenance (participants)
Time Frame: 32 weeks
We will determine the proportion of participants who continue MFBB at 32 weeks.
32 weeks
10-Meter Walk Test
Time Frame: 32 weeks
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed.
32 weeks
Four Square Test
Time Frame: 32 weeks
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.
32 weeks
Timed Up-And-Go Test
Time Frame: 32 weeks
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.
32 weeks
Champs Activity Questionnaire for Older Adults
Time Frame: 32 weeks
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.
32 weeks
SF-12
Time Frame: 32 weeks
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.
32 weeks
Falls Efficacy Scale
Time Frame: 32 weeks
The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Health and Human Services
Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5 R49 CE002109-DLJ

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