Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals

This novel study supports the positive benefits of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) to older adults identified as "at-risk" by their local senior center after participating in a prevention-focused multimodal program provided by physical therapists in their home.

Study Overview

• Status: Completed
• Conditions: Fall; Risk Reduction
• Intervention / Treatment: Other: HOP-UP-PT Program

Detailed Description

The purpose of this study was to describe the outcomes of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) program participants and then to compare these outcomes to non-participants. 144 participants (n=72 per group) will be randomized to either the HOP-UP-PT intervention group or the Normal level of activity group. Six Michigan senior centers will refer adults ≥ 65 years who were at-risk for functional decline or falls. Licensed physical therapists will deliver physical, environmental, and health interventions within their approved scope of practice to the HOP-UP-PT intervention group during nine encounters (six in-person, three telerehabilitation) delivered over seven months. The Normal level of activity group participants are told to continue their usual physical activity routines during the same timeframe. Baseline and re-assessments are conducted at 0-, 3-, and 7-months for both the HOP-UP-PT intervention group and Normal level of activity group. Descriptions and comparisons from each assessment encounter will be analyzed.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Rochester, Michigan, United States, 48309
      • Oakland University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Greater than or equal to 65 years of age
• Senior Community Center staff identified them as 'at-risk' for decline in community dwelling status due to physical, social, economic, or community-related barriers
• Willingness to participate

Exclusion Criteria:

• Received physical therapy services within the prior two months in any setting
• Had been hospitalized within the prior two months
• Were currently receiving palliative or hospice care
• Mini Cog score less than 4 and Trail Making Part B score greater than 273 seconds
• Outcomes American College of Sports Medicine exercise pre-participation health screening indicating physician clearance needed for participation and after evaluation the physician will not clear

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HOP-UP-PT Program; HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program	Other: HOP-UP-PT Program; Interventions provided to EG participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented.
NO_INTERVENTION: Normal Level of Activity; Normal Level of Activity group will be instructed to continue their normal level of activity throughout the 7-months after which they will be offered the opportunity to receive the HOP-UP-PT program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reported Falls	Record of falls in prior year, and between each subsequent visit.	7 months
Modified Short Physical Performance Battery (SPPB)	The Modified SPPB uses a 0-12 scale (0 = lowest function, 12 = highest function), calculated using collective outcomes of The Four Test Balance Scale (0= unable to perform, 1 = able to stand: feet together >10 sec, 2 = semi-tandem >10 sec, 4 = tandem stance >10 sec, higher score is better balance), 5 Time Sit to Stand (0 = >60 sec, 1=16.7 to 60 sec, 2 = 13.7 to 16.69 sec, 3 = 11.2 to 13.69 sec, and 4 = <11.19 sec, faster time is higher function), and the 3-meter gait speed test (0 = unable to perform, 1= > 6.52 sec, 2 = 4.66 to 6.52 sec, 3 = 3.62 to 4.65 sec, and 4 = < 3.62 sec, faster time is higher function). Each of the three categories has a highest score of 4 and are summed together for a highest total Modified SPPB score of 12.	7 Months
Timed Up and Go	The Timed Up and Go (TUG) is a times assessment of sit to stand transfer, 20 foot bought of ambulation with a 180 degree turn at 10 feet concluding with a stand to sit transfer.	7 Months
Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization	Low, moderate, and high risk was determined relative to results of the stay independent brochure, subjective report of falls and fall risk and brochure questions, as well as gait, strength, and balance assessment. The Stopping Elderly Accidents, Death & Injuries (STEADI) Algorithm underwent revisions since the study onset, the 2015 version was utilized as a guide for key outcome metrics reported in this study. Low STEADI risk =0, moderate STEADI risk =1, and high STEADI risk = 2. Low risk participants were categorized based on "no" responses to falls or fall risk questions as well as no gait, strength, or balance problems. Moderate risk participants were categorized by answering "yes" to key questions as well as demonstrating some gait, strength, or balance problems, and had a fall without injury. High risk participants were categorized by answering yes to key questions, demonstrating gait, strength, or balance problems, and had 2 or more falls or 1 fall with an injury.	7 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stay Independent Questionnaire	This questionnaire scores a fall risk on a scale from zero to 14, with 4 or more indicating a possible fall risk. Zero is the lowest fall risk score, 14 is a highest fall risk score.	3 Months
Modified Falls Efficacy Scale	Measures fear of falling for 10 indoor and 4 outdoor activities. For each statement the participant circles a number that corresponds to their level of confidence, with zero being no confidence and 10 being extreme confidence. Once all 14 items are scored, they are added for a total score maximum of 140 which is then divided by 14. A number closer to 14 equates to more confidence, and a number closer to zero equates to less confidence.	3 Months
Health Behavior Questionnaire	Assessment of current behaviors related to physical activity, consuming fruits and vegetables, not smoking, and being at a recommended weight. Patients are categorized using the five levels of the trans-theoretical model of behavior change. The pre-contemplating stage, or not ready for change is scored a 5. The contemplation stage or considering making a change in the next 6 months is scored a four. The preparation or preparing to make the change in the next 6 months is scored a 3. The action stage indicates the participant has made the change and is scored. The maintenance stage indicates the participants have maintained the change for at least 6 months and are scored a 1.	3 Months
Functional Comorbidity Index	Self-assessment of disease comorbidity with physical function as the outcome. 18 diagnoses are listed and if the participant has been diagnosed with the condition it would be marked at a 1 and if they do not have the condition it would be marked as a zero. Zero would be the fewest amount of co-morbidities and 18 would be the highest amount of co-morbidities.	7 Months
Home Falls and Accidents Screening Tool (Home FAST)	The tool evaluates 25 home safety domains and includes questions related to lighting, floor surfaces, and properly fitted foot wear. The original tool design was not scored but the investigators have added a scoring system (13 = safest environment to 50 = least safe environment) to quantify each question pertaining to the home environment. 13 home safety questions are scored as either Yes (indicating the recommended safety modifications was present) or No (indicating the recommended safety modifications had not been met). An additional 12 questions have an N/A option to be used in circumstances where a condition was not met (e.g., participant does not have a pet or stairs in the home). The investigators coded the responses as YES=1 point, NO= 2 points, an N/A= null within that category and not included during calculation. Therefore, overall Home FAST scores that decrease over time would suggest diminished home fall and accident risks related to their environment.	7 Months
Body Mass Index	Assessment of body fat calculated from height and weight.	7 Months
Blood Pressure	Assessment of mean resting blood pressure in seated position.	7 Months
Number of Participants With Orthostatic Hypotension	Blood pressure was measured sequentially in supine, seated and standing and orthostatic hypotension was determined by the following parameters: a systolic blood pressure decrease of greater than or equal to 20 mm Hg or a diastolic blood pressure decrease of greater than or equal to 10 mm Hg between any of the three positions after three minutes in that position.	7 months

Collaborators and Investigators

• Sponsor: Oakland University
• Collaborators: Michigan Health Endowment Fund
• Investigators: Principal Investigator: Sara Arena, DScPT, Oakland University

Publications and helpful links

General Publications

• Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. doi: 10.1093/ptj/77.8.812.
• Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.
• Wilson CM, Arena SK, Adcock K, Colling D. A Home-Based Older Person Upstreaming Prevention Physical Therapy (HOP-UP-PT) Program Utilizing Community Partnership Referrals. Home Healthc Now. 2019 Mar/Apr;37(2):88-96. doi: 10.1097/NHH.0000000000000716.
• Arena SK, Wilson CM, Peterson E. Targeted Population Health Utilizing Direct Referral to Home-Based Older Person Upstreaming Prevention Physical Therapy From a Community-Based Senior Center. Cardiopulm Phys Ther J. 2020;31(1):11-21. doi:10.1097/CPT.0000000000000131
• Wilson C, Arena SK, Starceski R, Swanson K. Older Adults' Outcomes and Perceptions After Participating in the HOP-UP-PT Program: A Prospective Descriptive Study. Home Healthc Now. 2020 Mar/Apr;38(2):86-91. doi: 10.1097/NHH.0000000000000843.
• Measuring orthostatic blood pressure. Center for Disease Control and Prevention. Published 2017. https://www.cdc.gov/steadi/materials.html
• Hill KD, Schwarz JA, Kalogeropoulos AJ, Gibson SJ. Fear of falling revisited. Arch Phys Med Rehabil. 1996 Oct;77(10):1025-9. doi: 10.1016/s0003-9993(96)90063-5.
• Black B, Marcoux BC, Stiller C, Qu X, Gellish R. Personal health behaviors and role-modeling attitudes of physical therapists and physical therapist students: a cross-sectional study. Phys Ther. 2012 Nov;92(11):1419-36. doi: 10.2522/ptj.20110037. Epub 2012 Jul 19.
• Groll DL, To T, Bombardier C, Wright JG. The development of a comorbidity index with physical function as the outcome. J Clin Epidemiol. 2005 Jun;58(6):595-602. doi: 10.1016/j.jclinepi.2004.10.018.
• Adult BMI Calculator. Center for Disease Control and Prevention. Published 2020. Accessed January 25, 2021. https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html
• STEADI: Algorithm for FallRisk Screening, Assessment, and Intervention. Center for Disease Control and Prevention. Published 2017. Accessed January 28, 2019. https://www.cdc.gov/steadi/materials.html
• Mackenzie L, Byles J, Higginbotham N. Reliability of the Home Falls and Accidents Screening Tool (HOME FAST) for identifying older people at increased risk of falls. Disabil Rehabil. 2002 Mar 20;24(5):266-74. doi: 10.1080/09638280110087089.
• Four Stage Balance Test. Center for Disease Control and Prevention. Published 2017. Accessed January 25, 2021. https://www.cdc.gov/steadi/pdf/4-Stage_Balance_Test-print.pdf
• Macfarlane DJ, Chou KL, Cheng YH, Chi I. Validity and normative data for thirty-second chair stand test in elderly community-dwelling Hong Kong Chinese. Am J Hum Biol. 2006 May-Jun;18(3):418-21. doi: 10.1002/ajhb.20503.
• Five Time Sit to Stand Test. Shirley Ryan Ability Lab. Published 2021. Accessed January 25, 2021. https://www.sralab.org/rehabilitation-measures/five-times-sit-stand-test
• Tiedemann A, Shimada H, Sherrington C, Murray S, Lord S. The comparative ability of eight functional mobility tests for predicting falls in community-dwelling older people. Age Ageing. 2008 Jul;37(4):430-5. doi: 10.1093/ageing/afn100. Epub 2008 May 16.
• Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.
• Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available. Erratum In: J Geriatr Phys Ther. 2009;32(3):110.
• Campbell A RM. Otago Exercise Program to Prevent Falls in Older Adults. Otago Medical School, University of Otago. Accessed January 25, 2021. https://www.livestronger.org.nz/assets/Uploads/acc1162-otago-exercise-manual.pdf
• Pignataro RM, Huddleston J. The Use of Motivational Interviewing in Physical Therapy Education and Practice: Empowering Patients Through Effective Self-Management. J Phys Ther Educ. 2015;29(2):62-71. doi:10.1097/00001416-201529020-00009
• Arena SK, Wilson CM, Boright L, Peterson E. Impact of the HOP-UP-PT program on older adults at risk to fall: a randomized controlled trial. BMC Geriatr. 2021 Oct 1;21(1):520. doi: 10.1186/s12877-021-02450-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): May 15, 2021
• Study Completion (ACTUAL): May 15, 2021

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (ACTUAL): March 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Older adults
• Other Study ID Numbers: 912215-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No