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

Accidental Falls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961037
• Other study ID #: 5 R49 CE002109-DLJ
• Status: Completed
• Phase: N/A
• First received: September 11, 2013
• Last updated: December 22, 2015
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Aged 55 years or older

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• Tai Chi: Moving for Better Balance
Participants will attend one-hour Tai Chi classes twice weekly for 16 weeks.

Locations

Country	Name	City	State
United States	Hughes River Presbyterian Church	Cairo	West Virginia
United States	Wesley United Methodist Church	Ellenboro	West Virginia
United States	Harper Memorial Church	Gandeeville	West Virginia
United States	First Baptist Church	Grantsville	West Virginia
United States	First Assembly of God	Harrisville	West Virginia
United States	Cisco Community Church	Petroleum	West Virginia
United States	First Baptist Church	Spencer	West Virginia
United States	Memorial United Methodist Church	Spencer	West Virginia
United States	Spencer Presbyterian Church	Spencer	West Virginia

Sponsors (3)

Lead Sponsor	Collaborator
West Virginia University	Centers for Disease Control and Prevention, Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Four Square Test	Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.	16 weeks	No
Other	Timed Up-And-Go Test	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	No
Other	Champs Activity Questionnaire for Older Adults	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	No
Other	SF-12	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	No
Other	Falls Efficacy Scale	The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.	16 weeks	No
Other	Translation of MFBB in the churches with respect to its Reach	We will determine the proportion of eligible older adults who participate in a 16-week church-based intervention of MFBB.	16 weeks	No
Other	Translation of MFBB in the churches with respect to its Adoption	We will determine the proportion of invited churches that offer MFBB.	16 weeks	No
Other	Translation of MFBB in the churches with respect to its Implementation	We will determine if MFBB was delivered as intended by its developer.	16 weeks	No
Other	Translation of MFBB in the churches with respect to its Maintenance (churches)	We will determine the proportion of churches who continue MFBB at 32 weeks.	32 weeks	No
Other	Translation of MFBB in the churches with respect to its Maintenance (participants)	We will determine the proportion of participants who continue MFBB at 32 weeks.	32 weeks	No
Other	10-Meter Walk Test	A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed.	32 weeks	No
Other	Four Square Test	Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.	32 weeks	No
Other	Timed Up-And-Go Test	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	No
Other	Champs Activity Questionnaire for Older Adults	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	No
Other	SF-12	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	No
Other	Falls Efficacy Scale	The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.	32 weeks	No
Primary	10-Meter Walk Test	A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed	16 weeks	No
Secondary	Number of fall-related injuries	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	Yes
Secondary	Number of falls	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	Yes