Engaging Residents to Become Research Pioneers in Fall Risk Management

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1 Engaging Residents to Become Research Pioneers in Fall Risk Management Kim Eichinger Executive Director of Fitness Country Meadows Retirement Communities Research Pioneers for Fall Risk Management The InVESTED Study 1

2 Financial Disclosure and Conflicts of Interest Grant to Motion Therapeutics for Balance Devices only Country Meadows, Inc. Primary Investigator not associated with Motion Therapeutics: Jennifer Vincenzo PT PhD Complimentary training in BBTW One investigator is a minor stakeholder in Motion Therapeutics Objectives Discover effective communication strategies required for a research study Identify requirements needed to launch and maintain a successful research program Practice or observe mobility disability and fall risk assessments Assimilate the outcomes of wearing a BalanceWear Vest on fall risk Take home Lessons learned from the researcher, clinician and research site 2

$This rate increases with increased age (CDC) Falls account for 87% of fractures of adults aged 65 years and over Fall-related injuries are$ among the most expensive health conditions In 2000 alone $179 million were spent on fatal falls $19 billion were spent on injuries from

among the most expensive health conditions In 2000 alone $179 million were spent on fatal falls $19 billion were spent on injuries from

3 Why Did We Encourage Residents To Participate In The InVESTED Study? 1/3 older adults suffer a fall each year. This rate increases with increased age (CDC) Falls account for 87% of fractures of adults aged 65 years and over Fall-related injuries are among the most expensive health conditions In 2000 alone $179 million were spent on fatal falls $19 billion were spent on injuries from non-fatal falls (Stevens, 2006) Fear of Falling a Downward Spiral Limits participation in activities Impaired mobility is a risk factor for falls Become more impaired 3

4 What Does Fall Risk Management Look Like Now? Walkers Sitting activities Gait Belts Exercise Current Interventions and Limitations Exercise Can improve many of the factors related to limited mobility (strength, power, balance, endurance) (De Vries et al., 2012; Pahor et al., 2014) Balance Training Requires at least 50 hours over 6 months (Shubert, 2014) 4

Likely even fewer older adults that engage in balance exercises (Clemson et al., 2012). Limitations adherence (Simek et al.

5 EXERCISE, the big -- BUT 28-44% of older adults do not engage in regular physical activity (National Center for Health Statistics, 2007) Only 11% participate in aerobic and muscle strengthening activities that meet federal guidelines (Tarver, 2013). Likely even fewer older adults that engage in balance exercises (Clemson et al., 2012). Limitations adherence (Simek et al., 2012) What Might Future Fall Prevention Strategies Look Like? What if we could offer an opportunity try an intervention that would allow older adults to simply WEAR THEIR BALANCE? 5

6 The InVESTED Study Determine the effect of balance-based torso-weighting (BBTW) Wearing a BalanceWear vest with strategically placed weight to control balance loss on walking, balance, fall risk and fear of falling in community dwelling older adults Balance-Based Torso-Weighting 3 Dimensional assessment of Balance loss assessment in all planes of movement Standing or sitting Everyday activities When nudged Small weight strategically placed to control the directional loss found in the assessment Light weights in 1/8, ¼ and ½ pound increments 6

The Team Researcher Jennifer Vincenzo PT, MPH, GCS, PhD University of Arkansas Clinical Cynthia Gibson-Horn PT Motion Therapeutics Inc Fitness and Communication Team Kim Eichinger Executive Director

7 The Team Researcher Jennifer Vincenzo PT, MPH, GCS, PhD University of Arkansas Clinical Cynthia Gibson-Horn PT Motion Therapeutics Inc Fitness and Communication Team Kim Eichinger Executive Director of Fitness Three Country Meadows Fitness Directors Communication Team Participants Country Meadows Resident Volunteers at 3 sites Recruitment of Resident Volunteers? Communication Strategies Development of the name for the Study Create Communication materials Community Education Volunteer Recognition Local Media Coverage 7

8 Promotional Flyers Presentations were held to introduce the study and meet members of the researcher team. Volunteers Needed! Recruitment Flyer Distributed by the campus Fitness Director 8

Lobby Posters InVESTED Project Celebrating Participants Information Cards Volunteer Button Prepare for Possible Questions BalanceWear Vest Study Frequently Asked Questions Below is information we

Volunteers must be 65 years or older with balance or mobility difficulties and a willingness to participate. What can this vest possibly improve in someone who qualifies?

challenges seniors can experience. Will there be a charge to participate? No. Costs will be covered by Country Meadows.

After volunteering to participate, why was I ultimately not selected?

9 Lobby Posters InVESTED Project Celebrating Participants Information Cards Volunteer Button Prepare for Possible Questions BalanceWear Vest Study Frequently Asked Questions Below is information we thought you may have questions about to help you better understand the Balance Wear research volunteer opportunity. What are the qualifications to participate? Volunteers must be 65 years or older with balance or mobility difficulties and a willingness to participate. What can this vest possibly improve in someone who qualifies? While the BalanceWear vest benefits vary per individual limitations, the company has seen improvements in balance, ability to walk, speech, climb stairs, even handwriting all of which are common challenges seniors can experience. Will there be a charge to participate? No. Costs will be covered by Country Meadows. BalanceWear Vest Opportunity to address concerns that residents may not wish to express in public setting. Prompt residents to ask related questions. After volunteering to participate, why was I ultimately not selected? The University of Arkansas and Motion Therapeutics research team will evaluate every volunteer to determine if he/she fits their established criteria. Country Meadows has no say on who is selected for the study. If I qualify to participate, does this mean you will move me to a higher level of care? No. Participation in the study does not mean that you are identified as needing a higher level of care. Who is the main campus contact if I have any questions or concerns about and during the study? Country Meadows Fitness Director Renee Harlow. She may be reached at , extension 60505, or via at RHarlow@CountryMeadows.com. Our physical and occupational therapy teams also will be involved with assessments and vest fittings. 9

10 What Were the Participants Asked To Do In The InVested Study? Health History Questionnaire Mini-Mental State Exam Falls Efficacy Scale Assessment of Function and Balance (5 times during 4 month period and 6 times for the 6 month data) Wear BalanceWear device 4 hours per day Maintain daily log of wear time, activities, pain level and incidence of falls Inclusion/Exclusion Criteria Inclusion Older than 65 Years Walk a minimum of 30 feet repeatedly Mimi mental score 24/30 SPPB score 4-9/12 Be able to follow instruction Be available for up to 5 days, 4 months, or 6 months Exclusion Neurological problem Pain or physical impairment Beyond mild cognitive issues Severe visual impairment Uncontrolled Cardiovascular disease Diabetes 10

11 Pre Screening Two Tests Qualified The Participants Mini Mental exam Short Physical Performance Battery Medical History Fitness Directors Communication to Recruit residents at each site Sign an Informed Consent Determine if participants met criteria for the study Perform the Mini Mental Test Short Physical Performance Battery Measure all the participants to get their devices Falls Efficacy Scale Transporting residents Assist with researcher with outcome measures Support participants throughout the study 11

12 Short Physical Performance Battery Qualification: Score 4-9 < 6 associates high risk of falling and mobility disability 12

13 Motion Therapeutics, Inc /6/2017 Falls Efficacy Scale (Delbaere, 2010) >23/64 Increase Falls Garment Measurement to Customize Vest 26 13

14 Organization/Coordination Coordinate 3 days of assessments at 3 different sites Managing resident assessment times Equipment/Tools for Assessments Planning for appropriate space Accommodating resident needs transport/escort to assessment site nutrition/hydration monitor fatigue Coordinating 3 Campus Schedules Assessment and Weighting Schedule Hershey Ecumenical West Shore Monday 11/3 9:15 Hershey Team meeting and set up 10:45 5:00 Vest fitting and Initial assessments Tuesday 11/4 8:00 Ecumenical Team meeting and set up 9:15 12:00 Vest fitting and initial assessments Hershey 1:30 5:00 Day one assessments Wednesday 11/5 8:00 Ecumenical Day one assessments 12:30 West Shore Team meeting and set up 1:30 5:00 Vest fitting and initial assessments Thursday 11/6 9:00 12:00 Catch up at any location where we did not reach everyone 1:30 5:00 West Shore Day one assessments Friday 11/7 We can use this day as well to follow up with residents Saturday 11/8 9:00 1:00 Hershey Day 5 assessments Sunday 11/9 9:00-1:00 Ecumenical Day 5 assessments Monday 11/10 9:30 1:30 West Shore Day 5 assessments Tuesday 11/11 Follow up as needed at any of the locations 14

educated on vest care and donning/doffing assistance Fitness Director maintained contact

15 Volunteer assessment schedule prompts Providing Resident Support During Study Period Study participants identified to clinical team at each campus Personal care staff educated on vest care and donning/doffing assistance Fitness Director maintained contact with residents 3 check ups each month by clinician through the studytherapy check-in as needed 15

16 Results at 5 day, 4 and 6 months 5 Day - 33 participants 4 months - 24 participants Six dropped out do to illness or death. One participant died and there were two spousal deaths. 6 months - 20 participants Average age of the participants was 86 years old 5-Day Study Blinded Random allocation Tested after 5 days No Vest 16

Positive Outcomes After 5 Days of Wear in Blinded RCT Increase of 1.25 points over control with fake weights 1 point increase is significant What Does SPPB Predict?

17 Positive Outcomes After 5 Days of Wear in Blinded RCT Increase of 1.25 points over control with fake weights 1 point increase is significant What Does SPPB Predict? Risk of disability among the community-dwelling older adults Mortality Admission to a nursing home Reliance on health care Decline in ADLs Development of disability (inability to perform ADLs or decreased mobility) Studenski S, Perera S, Wallace D, et al. Physical performance measures in the clinical setting. J Am Geriatr Soc 2003;51: Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med 1995;332:

18 4 Month Study All participants given BalanceWear Not blinded or randomized All participants tested at 4-months without garment Assessments Mean Std. Deviation Change P Fall risk cut off Five Times Sit to Stand Test Fall Risk Reduced at 4 Months No Control Group Pre test FTSST (secs) Improved by 9.88 s 5.047* 15 s 8 Post test FTSST Tandem stance time Pre test tandem (secs) Improved by 3.34 s s 9 Post test tandem Gait speed Pre test gait_speed (m/s) Improved by 0.09 s 6.004* 0.7 m/s 10 Post test gait_speed Short Physical Performance Battery Pre test SPPB (units) Improved by 1.31 units 7.001* 6/12 11 Post test SPPB Functional Gait Assessment Pre test FGA Improved by 2.58 units <.001* 22/30 12 Post test FGA Timed Up and Go Test Pre test TUG Improved by 3.15 s.008* Post test TUG Falls Efficacy Scale Pre test FES Improved by 1.31 units /64 14 Post test FES

19 5 Times Sit to Stand Measures Transitional movement Strength Balance Our study demonstrated improvement beyond a fall risk Not all residents could perform this task, but for those who could we saw a reduction in fall risk Walking Speed Matters 19

20 Timed Up and Go (TUG) Test Average improvement 3 seconds seconds Each second related to decreased fall risk Falls Efficacy Scale No change at 4 months 20

6 Months 20 Participants All did the same exercise program 9 + BalanceWear 11 no BalanceWear 6 Month Comparison group EX ONLY (n = 11) EX BWT (n = 9) P Pre CHANGE Post Pre CHANGE

21 6 Months 20 Participants All did the same exercise program 9 + BalanceWear 11 no BalanceWear 6 Month Comparison group EX ONLY (n = 11) EX BWT (n = 9) P Pre CHANGE Post Pre CHANGE Post SPPB (au) 6.36 (1.57) (2.15) 6.56 (2.19) (2.45).04* TUG (s) (7.74) (6.13) (7.27) (5.20).058 Participants tested without Vest 21

22 6 Month Results Significant improvements in SPPB score 1.77 units BWG points indicates clinical improvement (Kwon et al., 2009; Perera et al., 2006). Similar to 4-6 month exercise interventions 0.52 units in self-administered DVD exercise group (McCauley et al., 2013) units high or low velocity resistance exercise (Reid et al., 2014) Lessons Learned Pro s Improvement in Fall Risk Improved Mobility Participant Engagement Feeling of being a part of something to help this generation and others Helped company with design of future products Opportunities Learned what support systems are required to launch a fall risk program in community living centers Develop and understanding of the support staff required Implement changes in product design for older adults 22

23 Wear their Balance.YES! 23

Falls and Mobility. Katherine Berg, PhD, PT and Arielle Berger, MD. Presented by: Ontario s Geriatric Steering Committee

Falls and Mobility. Katherine Berg, PhD, PT and Arielle Berger, MD. Presented by: Ontario s Geriatric Steering Committee Falls and Mobility Katherine Berg, PhD, PT and Arielle Berger, MD Key Learnings Arielle Berger, MD Key Learnings Learn approaches to falls assessment Understand inter-relationship between promoting safe