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Smart Television and Exercise Promotion for Independent Living Facilities (STEP4Life)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03001778
Recruitment Status : Completed
First Posted : December 23, 2016
Results First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Klein Buendel, Inc.

Study Description
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Brief Summary:
Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g., increased strength and balance, reduced frailty, fewer falls, improved brain function, lower mortality risk), yet many seniors have limited access to exercise options due to numerous barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This project will overcome common exercise barriers by creating an interactive web-enabled TV program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF residents and administrators will be able to create, use, and evaluate a customizable exercise program tailored to the individual's preferred type of exercise, intensity, and duration.

Condition or disease Intervention/treatment Phase
Aging Physical Activity Other: Usability Testing Not Applicable

Detailed Description:
Older Adults (OAs), aged 65 years and older, are the fastest growing segment of the U.S. population. As life expectancy increases, maintaining physical independence has become a public health priority. It is well recognized that regular physical activity (PA) can be done safely by seniors, and has multiple physical, emotional, and cognitive benefits. Yet, they remain the least physically active of any age group. This suggests that the translational reach of efficacious PA protocols to the real-world remains limited, and a need for research which is scalable to the individual in more naturalistic settings exists. An emerging trend for seniors is to choose Independent Living Facilities (ILFs) as their home. ILFs offer a variety of social, cultural, and fitness services. Access to up-to-date technologies (e.g., wireless Internet), web-based education, and wellness programs are a priority for ILF residents, thus opportunities for using technology for health promotion with OAs exists. ILFs provide a unique opportunity for PA promotion, because 1) more seniors are choosing ILFs for aging-in-place, 2) PA is of interest to ILF residents, 3) ILFs should continue to increase their wellness offerings, and 4) ILFs should be interested in incorporating PA programs into wellness offerings. Research is needed to translate efficacious PA protocols for seniors into formats that are scalable to OAs in real-world settings. The goal is to extrapolate knowledge gained from efficacy research to improve the utilization and sustainability of evidence-based methods by producing programs that are agreeable, user-friendly, and optimal at both the individual and organizational level. Smart Television and Exercise Promotion for Independent Living Facilities (STEP for LIFE) will establish the feasibility for translating an evidence-based PA program using an interactive web-enabled, streaming-video technology (i.e., Smart TV) for ILF residents. This program offers 1) an innovative and potentially effective medium to reach seniors, 2) the ability to select and sequence together a session that is personalized to fitness level, type of exercise, and duration, and 3) organizations the ability to provide desired wellness options which meet both resident and organizational needs. The purpose of this study is to provide the initial research for translating efficacious research-based PA protocols for seniors into a scalable format usable in a real-world ILF setting, and to gain knowledge at individual and organizational levels to improve implementation and sustainability of this evidence-based approach. Specific Aims include extensive formative research on the use, interest, and effectiveness of interactive multimedia approaches for promoting PA, and its integration into senior living settings. A working prototype will be developed and tested for usability with ILF residents and administrators, and seniors not residing in ILFs. Outcomes will establish the feasibility of producing and testing STEP for LIFE in a large-scale randomized trial. A larger trial can inform 1) future translation of PA promotion to other OA residential settings (e.g., assisted living, memory care, rural settings), and 2) sustainable implementation strategies for other evidence-based health promotion protocols for seniors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Smart Television and Exercise Promotion for Independent Living Facilities
Actual Study Start Date : August 15, 2014
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Usability Testing
Prototype testing
 Other: Usability Testing
Usability testing of "ready made" workouts in a group format.


Outcome Measures
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Primary Outcome Measures :
  1. System Usability Scale (SUS) [ Time Frame: After 1 hour usability session ]
    Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Independent Living Facility (ILF) Resident Inclusion Criteria:

  • 55 years of age or older
  • live in an ILF
  • able tor read and speak English
  • able to consent to participate
  • exercise 60 min or more a week (self-reported)

ILF Resident Exclusion Criteria:

  • under 55 years of age
  • not live in an ILF
  • unable to read and speak English
  • unable to consent to participate
  • exercise less than 60 minutes (self-reported)

Non-ILF Resident Inclusion Criteria:

  • 55 years of age or older
  • not live in an ILF
  • able to read and speak English
  • able to consent to participate
  • exercise 60 min or more a week (self-reported)

Non-ILF Resident Exclusion Criteria:

  • under 55 years of age
  • live in an ILF
  • unable to read and speak English
  • unable to consent to participate
  • exercise less than 60 minutes (self-reported)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001778


Locations
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United States, Colorado
Klein Buendel, Inc.
Golden, Colorado, United States, 80401
Sponsors and Collaborators
Klein Buendel, Inc.
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Valerie Myers, PhD' Klein Buendel, Inc.
  Study Documents (Full-Text)

Documents provided by Klein Buendel, Inc.:
Statistical Analysis Plan  [PDF] August 19, 2014
Study Protocol  [PDF] July 8, 2014

More Information
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Publications:
Stevens JA, Sogolow ED. Preventing Falls: What Works: A CDC Compendium of Effective Community-Based Interventions From Around the World. National Center for Injury Prevention and Control; 2008.
National Prevention Council, Health Promotion Council, Public Health Council. Active Living. The National Prevention Strategy. http://www.surgeongeneral.gov/initiatives/prevention/strategy/report.html. June 16, 2011.
Schillinger D. An introduction to effectiveness, dissemination and implementation research. In: Fleisher P, Goldstein E, editors. San Francisco: Clinical Translational Science Institute Community Engagement Program, University of California San Francisco; 2010.
U.S.Department of Health and Human Services. 2008 physical activity guidelines for Americans. Be active, healthy, and happy. Publication No.U0036 http://www.health.gov/paguidelines/. 2008.
The Society of Certified Senior Advisors. State of the senior housing industry. The Society of Certified Senior Advisors Web site. http://www.csa.us/docs/StateoftheSeniorHousingIndustryReport.pdf. 2011.
Brecht S, Fein S, Hollinger-Smith L. Preparing for the future: trends in continuing care retirement communities. Seniors Housing & Care Journal. 2009;17(1):75-90.
Mather Lifeways Institute on Aging. Trend survey reveals future of senior living communities. http://matherlifeways.com/archives/1373. May 19, 2009.

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Responsible Party: Klein Buendel, Inc.
ClinicalTrials.gov Identifier: NCT03001778    
Other Study ID Numbers: R21AG046670 ( U.S. NIH Grant/Contract )
5R21AG046670 ( U.S. NIH Grant/Contract )
0283 ( Other Identifier: Klein Buendel, Inc. )
First Posted: December 23, 2016    Key Record Dates
Results First Posted: September 20, 2018
Last Update Posted: September 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Klein Buendel, Inc.:
Physical Activity
Older Adults
Independent Living Facilities
Multimedia technology