KOSO (Keep On Stepping On)/ Stepping Online

NCT02774889 | Completed Results

• 3 other identifiers: 2014-0125A534255SMPH/MEDICINE/GER-AD DEV
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fall Related Injury; Social Isolation

Keywords

Falls Prevention; Stepping On; Health Promotion; Implementation; Health Maintenance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• 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

Study Arms (2)

Stepping Online

ACTIVE COMPARATOR

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.

Behavioral: Stepping Online

Stepping On Usual Care Control

NO INTERVENTION

Subjects control workshops in the condition will not have access to Stepping Online.

Interventions

Stepping Online BEHAVIORAL

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

Also known as: Keep On Stepping On (KOSO)

Stepping Online

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Leader/Peer Leader: Leading a SO workshop in Dane, Milwaukee, Rock, Adams, Green Lake, Marquette or Waushara counties during the timeframe prior to the 6-month trial.
• Stepping On Participants/Graduates: Enrolled in one of the above SO workshops.
• In Milwaukee and Dane counties, extra effort will be made to enroll African American Stepping On participants/graduates, who are more likely to have lower income and educational level and to be uninsured than their White counterparts.

You may not qualify if:

• Leaders/Peer Leaders:
• Not available to participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
• Not in the area at the end of the 6-month trial.
• Stepping On Participants/Graduates:
• Unable participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
• Not assessed to be safe by SO leader to do the online exercise program; not in the area for the 3 month and 6 month evaluations

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Related Publications (8)

• 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.

  PMID: 22872695 BACKGROUND

• 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.

  PMID: 8126356 BACKGROUND

• 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.

  PMID: 18504506 BACKGROUND

• 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.

  PMID: 19543809 BACKGROUND

• 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.

  PMID: 21804645 BACKGROUND

• 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.

  PMID: 15341550 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39360568 DERIVED

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Associate Research Specialist
• Organization: University of Wisconsin-Madison

wpalmer3@wisc.edu

6082631105

Study Officials

• Jane E Mahoney, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 17, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: April 30, 2018
• Last Updated: January 31, 2022
• Results First Posted: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share