Clinical trial NCT04814459: Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals
Official title: Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Risk Reduction
Keywords: Older adults
Lead sponsor: Oakland University
Sponsor class: OTHER
Collaborators: name: Michigan Health Endowment Fund
First posted: 2021-03-24
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group (EG) participated in the 7-month HOP-UP-PT control group (CG) included only baseline, 3-month, and 7-month assessments. The CG was instructed to continue their normal level of activity throughout the 7-months after which they were offered the opportunity to receive the HOP-UP-PT program. This study reports only the 7-month time frame during which the EG and CG can be directly compared.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Reported Falls
timeFrame: 7 months
measure: Modified Short Physical Performance Battery (SPPB)
timeFrame: 7 Months
measure: Timed Up and Go
timeFrame: 7 Months
measure: Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization
timeFrame: 7 Months
Secondary outcomes:
measure: Stay Independent Questionnaire
timeFrame: 3 Months
measure: Modified Falls Efficacy Scale
timeFrame: 3 Months
measure: Health Behavior Questionnaire
timeFrame: 3 Months
measure: Functional Comorbidity Index
timeFrame: 7 Months
measure: Home Falls and Accidents Screening Tool (Home FAST)
timeFrame: 7 Months
measure: Body Mass Index
timeFrame: 7 Months
measure: Blood Pressure
timeFrame: 7 Months
measure: Number of Participants With Orthostatic Hypotension
timeFrame: 7 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Oakland University
state: Michigan
Study officials:
affiliation: Oakland University
name: Sara Arena, DScPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: Measuring orthostatic blood pressure. Center for Disease Control and Prevention. Published 2017. https://www.cdc.gov/steadi/materials.html
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.
citation: 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
citation: 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.
citation: 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
citation: 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.