NCT02774889|CompletedResults
KOSO (Keep On Stepping On)/ Stepping Online
Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet
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Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet
Sponsor study identifier
Secondary identifiers
OTHER · UW, Madison
OTHER · UW, Madison
interventional
45
0 countries
N/A
Study Start
July 2016
Actual (reported)Primary Completion
January 2018
Actual (reported)Study Completion
April 30, 2018
Actual (reported)The overall purpose of this multi-phase study is to develop (Phase 1) and test potential effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls prevention maintenance program for Stepping On (SO) graduates in a group randomized trial (Phase 2). This application refers to effectiveness component of Phase 2, which entails the randomized clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail process evaluation of the Stepping Online intervention group only.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 11, 2016
Actual (reported)May 17, 2016
Actual (reported)July 2016
Actual (reported)January 2018
Actual (reported)April 30, 2018
Actual (reported)January 24, 2022
Actual (reported)Change of Number of Falls From Baseline to 6 Months
Number of Falls: monthly calendar self-administered sent and returned via mail
baseline and 6 months
Number of Tandem Walk Errors at 3 Months and 6 Months
up to 6 months
Gait Speed at 3 Months and 6 Months
up to 6 months
Short Physical Performance Battery (SPPB): Total Balance Test
up to 6 months
Short Physical Performance Battery (SPPB): Gait Speed Test
6 months
Short Physical Performance Battery (SPPB): Chair Stand Test
up to 6 months
Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors. 1. Fall prevention tips 2. Fall prevention exercise videos noting technique and safety 3. Guest expert videos and communication with expert 4. Tools to set exercise goals, reminders and track progress 5. Fall prevention specialist for feedback and group activities 6. Discussion and messaging (1:1, small and large group) 7. Fall prevention resources.
Subjects control workshops in the condition will not have access to Stepping Online.
Stepping Online is a password-protected website with Stepping On graduates, whose groups are randomized to Stepping Online and will have access to and training in a password-protected website. The website includes: 1. Fall prevention tips 2. Fall prevention exercise videos with narrations for proper technique and safety precautions 3. Guest expert videos with online access to the guest expert to ask questions 4. Tools to set exercise goals, get reminders and track progress 5. Access to a fall prevention specialist for personal feedback and suggested group homework 6. Group discussion and messaging (one-to-one and with their fellow Stepping On workshop participants group, or with all Stepping Online participants and leaders) 7. Fall prevention resources
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Clemson L, Fiatarone Singh MA, Bundy A, Cumming RG, Manollaras K, O'Loughlin P, Black D. Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. BMJ. 2012 Aug 7;345:e4547. doi: 10.1136/bmj.e4547.
Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
Limitations include the small sample size. With multiple tests/measures significance might have been by chance. Bonferroni corrections were not performed. Fewer than 30% of the SO graduates who were invited enrolled in the study; these results may not be generalizable to all SO graduates. Lack of access to and comfort with online devices were barriers for some refusers.
Jane E Mahoney, MD
University of Wisconsin, Madison
45 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2016
First Posted
May 17, 2016
Study Start
July 2016
Actual (reported)Primary Completion
An Effectiveness-implementation Hybrid Study of Social Prescribing in a Singapore Community Hospital Setting
Contact the study team to confirm eligibility.
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
Gustafson DH, Hawkins R, McTavish F, Pingree S, Chen WC, Volrathongchai K, Stengle W, Stewart JA, Serlin RC. Internet-Based Interactive Support for Cancer Patients: Are Integrated Systems Better? J Commun. 2008 Jun;58(2):238-257. doi: 10.1111/j.1460-2466.2008.00383.x.
Clemson L, Cumming RG, Kendig H, Swann M, Heard R, Taylor K. The effectiveness of a community-based program for reducing the incidence of falls in the elderly: a randomized trial. J Am Geriatr Soc. 2004 Sep;52(9):1487-94. doi: 10.1111/j.1532-5415.2004.52411.x.
Mahoney, J. E., Gangnon, R., Clemson, L. M., Gobel, V. L., & Lecey, V. (2012, November). Evaluation of stepping on implementation across Wisconsin. In GERONTOLOGIST (Vol. 52, pp. 479-479). JOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA: OXFORD UNIV PRESS INC.
Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
January 2018
Actual (reported)Study Completion
April 30, 2018
Actual (reported)Last Updated
January 31, 2022
Results First Posted
January 24, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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