NCT04814459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 11, 2021

Completed
Last Updated

October 11, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

March 22, 2021

Results QC Date

May 19, 2021

Last Update Submit

September 14, 2021

Conditions

Keywords

Older adults

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • Stay Independent Questionnaire

    3 Months

  • Modified Falls Efficacy Scale

    3 Months

  • Health Behavior Questionnaire

    3 Months

  • Functional Comorbidity Index

    7 Months

  • Home Falls and Accidents Screening Tool (Home FAST)

    7 Months

  • +3 more secondary outcomes

Study Arms (2)

HOP-UP-PT Program

EXPERIMENTAL

HOP-UP-PT Program group will participate in the 7-month HOP-UP-PT program

Other: HOP-UP-PT Program

Normal Level of Activity

NO INTERVENTION

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

Interventions

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.

HOP-UP-PT Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oakland University

Rochester, Michigan, 48309, United States

Location

Related Publications (21)

  • 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.

    PMID: 30829786BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 32134816BACKGROUND
  • Measuring orthostatic blood pressure. Center for Disease Control and Prevention. Published 2017. https://www.cdc.gov/steadi/materials.html

    BACKGROUND
  • 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.

    PMID: 8857881BACKGROUND
  • 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.

    PMID: 22822236BACKGROUND
  • 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.

    PMID: 15878473BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 12004972BACKGROUND
  • 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.

    PMID: 9256869BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 16634026BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 18487264BACKGROUND
  • 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.

    PMID: 28003033BACKGROUND
  • Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.

    PMID: 20039582BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 24339273BACKGROUND
  • 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

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Sara Arena
Organization
Oakland University

Study Officials

  • Sara Arena, DScPT

    Oakland University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

January 1, 2019

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

October 11, 2021

Results First Posted

October 11, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared

Locations