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Trial record 1 of 60 for:    PASSAGE | West Virginia, United States
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Use of Tele-Exercise for Translating an Evidence-Based Fall-Prevention Program for Older Adults in West Virginia

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ClinicalTrials.gov Identifier: NCT03714100
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dina L Jones, PT, PhD, West Virginia University

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE November 1, 2018
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Four Square Test [ Time Frame: At 16 weeks after start of intervention ]
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in 4 directions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Gait Speed: 5-meter walk test [ Time Frame: Collected at end of the intervention (16 weeks) ]
    A self-selected walking speed will be used to measure gait speed.
  • Mobility: Timed up-and-go test [ Time Frame: Collected at end of the intervention (16 weeks) ]
    A participant stands from a chair, walks 3 meters at a self-selected pace, turns, and returns to the chair to sit.
  • Lower extremity strength: 5-chair stands test [ Time Frame: Collected at end of the intervention (16 weeks) ]
    A participant is times as they stand up from a seated position five times. The test ends when the participant achieves the standing position on the 5th repetition.
  • Physical Activity: National Health Interview Survey (NHIS) [ Time Frame: Collected at end of the intervention (16 weeks) ]
    2016 NHIS questions
  • Health-related quality of life: Short Form-12 (SF-12) [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Questionnaire used to measure functional health and well-being from the participant's point of view.
  • Fear of falling: Falls Efficacy Scale [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.
  • Fall frequency (falls, fallers, and frequent fallers) [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
  • Fall rates (falls/person-months) [ Time Frame: Collected at baseline, at the end of the intervention (16 weeks), and 32 weeks after the start of the study ]
    Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
  • Injury frequency [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
  • Injury severity [ Time Frame: Collected at end of the intervention (16 weeks) ]
    If an injury was reported on the falls calendar, we will conduct a telephone interview with the participant to obtain the mechanism of the fall, the type and severity of any injuries, and details about any medical care that was received.
  • Medical care received [ Time Frame: Collected at end of the intervention (16 weeks) ]
    If an injury was reported on the falls calendar, we will conduct a telephone interview with the participant to obtain the mechanism of the fall, the type and severity of any injuries, and details about any medical care that was received.
  • Process outcomes [ Time Frame: Collected at end of intervention (16 weeks) ]
    Exercise adherence and adverse events will be collected via attendance and injury forms
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Gait Speed: 5-meter walk test [ Time Frame: Collected at end of the intervention (16 weeks) ]
    A self-selected walking speed will be used to measure gait speed.
  • Mobility: Timed up-and-go test [ Time Frame: Collected at end of the intervention (16 weeks) ]
    A participant stands from a chair, walks 3 meters at a self-selected pace, turns, and returns to the chair to sit.
  • Lower extremity strength: 5-chair stands test [ Time Frame: Collected at end of the intervention (16 weeks) ]
    A participant is times as they stand up from a seated position five times. The test ends when the participant achieves the standing position on the 5th repetition.
  • Physical Activity: National Health Interview Survey (NHIS) [ Time Frame: Collected at end of the intervention (16 weeks) ]
    2016 NHIS questions
  • Health-related quality of life: Short Form-12 (SF-12) [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Questionnaire used to measure functional health and well-being from the participant's point of view.
  • Fear of falling: Falls Efficacy Scale [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.
  • Fall frequency (falls, fallers, and frequent fallers) [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
  • Fall rates (falls/person-months) [ Time Frame: Collected at baseline, at the end of the intervention (16 weeks), and 32 weeks after the start of the study ]
    Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
  • Injury frequency [ Time Frame: Collected at end of the intervention (16 weeks) ]
    Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
  • Injury severity [ Time Frame: Collected at end of the intervention (16 weeks) ]
    If an injury was reported on the falls calendar, we will conduct a telephone interview with the participant to obtain the mechanism of the fall, the type and severity of any injuries, and details about any medical care that was received.
  • Medical care received [ Time Frame: Collected at end of the intervention (16 weeks) ]
    If an injury was reported on the falls calendar, we will conduct a telephone interview with the participant to obtain the mechanism of the fall, the type and severity of any injuries, and details about any medical care that was received.
  • Participant correlates [ Time Frame: Collected at baseline ]
    The following will be collected via a self-administered questionnaire: sociodemographics, medical/fall history, medications, assistive devices, body mass index
  • Site correlates [ Time Frame: Collected at baseline ]
    The following will be collected from the sites via site survey data: type, size, and demographics
  • Process outcomes [ Time Frame: Collected at end of intervention (16 weeks) ]
    Exercise adherence and adverse events will be collected via attendance and injury forms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Tele-Exercise for Translating an Evidence-Based Fall-Prevention Program for Older Adults in West Virginia
Official Title  ICMJE Use of Tele-Exercise as an Alternative Delivery Channel for Translating an Evidence-Based Fall-Prevention Program Into Practice for Older Adults in West Virginia
Brief Summary

West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, Centers for Disease Control and Prevention (CDC)-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others.

Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.

Detailed Description

West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, CDC-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others. We recently completed a CDC-funded study which successfully translated a 16-week TJQMBB intervention into 20 faith-based organizations in 7 rural WV counties. In the maintenance phase of the study (i.e., post intervention), only 38% of classes continued despite the fact that 87% of participants expressed a desire to continue. The rate limiting factor for continuing classes in these rural areas was lack of instructors. Thus, there is a vital need to further translate TJQMBB into practice using alternative delivery channels to increase the reach and maintenance of the program, especially in rural areas where instructors are less available.

Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.

The purpose of this translational study is to work with our injury control, technology, and wellness partners to: 1) implement a 16-week intervention of the tele-TJQMBB classes in 120 older adults at 12 community sites in 4 WV counties; 2) describe functional, self-reported, and fall/injury outcomes; and 3) evaluate the translation of tele-TJQMBB with respect to its Reach into the target population (number of participants), Effectiveness (participant outcomes), Adoption (number of sites, instructors, classes), Implementation (fidelity ratings), and Maintenance (satisfaction, continued participation) using the Re-aim Framework. Demonstrating that tele-TJQMBB is effective would provide an additional delivery channel for the program, help overcome the barrier of identifying instructors in rural areas, and in the future, allow for the number of classes to be expanded to reach more older adults, provide more community-based programs in which to refer older adults to, and enhance overall maintenance of the program. To our knowledge, this is the first study to translate an evidence-based, group, fall-prevention exercise program using an alternative delivery method in a priority population, and thus, may serve as a model for reaching other underserved older adults.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Accidental Falls
Intervention  ICMJE Behavioral: Tai Ji Quan: Moving for Better Balance
Participants will attend one-hour Tai Ji Quan: Moving for Better Balance classes twice a week for 16-weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed.
Other Name: Tai Chi, Physical Activity, Exercise
Study Arms  ICMJE Experimental: MFBB intervention
All participants will attend Tai Ji Quan: Moving for Better Balance classes twice a week for 16 weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed.
Intervention: Behavioral: Tai Ji Quan: Moving for Better Balance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2020)
52
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
120
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults age 55 and older
  • Community-dwelling
  • Able to attend 2, 1-hour Tai Ji Quan: Moving for Better Balance classes a week for 16 weeks
  • Able to attend 2 testing sessions for data collection (Testing sessions will be scheduled the week before classes begin and the week after the classes end)
  • Able to walk at least 2 city blocks with or without an assistive device

Exclusion Criteria:

  • Lack reliable transportation
  • Unable to speak English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03714100
Other Study ID Numbers  ICMJE 3R49CE002109-05S1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dina L Jones, PT, PhD, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dina L Jones, PT, PhD West Virginia University
PRS Account West Virginia University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP