Clinical trial NCT02774889: KOSO (Keep On Stepping On)/ Stepping Online
Official title: Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Related Injury
Social Isolation
Keywords: Falls Prevention
Stepping On
Health Promotion
Implementation
Health Maintenance
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Aim:

This application, for Phase 2 of a larger study, is a 6-month group randomized trial to test the effectiveness of Stepping Online.

Stepping Online (developed in Phase 1) is a continuation website to help Stepping On graduates to:

1. Maintain exercises and fall prevention strategies learned in Stepping On, and
2. Stay connected with other participants and leaders/peer leaders in the 7-week workshop.

Approach:

1. Subject Eligibility:

   1. Stepping On leaders and peer leaders of Milwaukee, Dane, Rock, Adams, Green Lake, Marquette and Waushara Counties during the enrollment window
   2. Stepping On participants/graduates of the above workshops whose leader assesses that they can safely use Stepping Online to exercise at home
2. Recruitment and Consenting:

   1. Leaders/Peer Leaders: County aging unit coordinators will invite leaders to participate in the study and share the names of those who agree with the study research staff. Staff will then explain the study in detail, answer questions, and obtain informed consent from those who agree.
   2. Participants: (1) Research staff will visit participating leader/peer leader workshops to explain the study; (2) leader will distribute a card for participants to agree to a researcher phone call to learn more. They will then share the contact information of those who agree with study research staff; (3) study research staff members will contact and conduct a recruitment interview by phone. They then schedule those who agree to come to the site where the workshop occurred (or another public place that is private and convenient for research subjects) for consenting and baseline measurement.
3. Randomization

   Randomization will occur on the Stepping On workshop level to ensure that leaders, peer leaders and participants are in the same arm. Procedures:
   1. County liaisons, who routinely collect data, will provide participants' education level (without personal identifiers);
   2. Study biostatistician pairs workshops based on above data, as well as geographic location and other data to ensure comparability.
   3. Participants from each designated pair of SO workshops will provide informed consent and participate in baseline measurements
   4. Designated pair of SO workshops will be randomized to the Stepping Online (intervention) or to the usual care Control arm.

   <!-- -->

   1. Intervention arm: Stepping On graduates (and their leaders/peer leaders) will receive the Stepping Online website for 6 months. They can use their own computer or receive a laptop and Internet access (if needed) for the study duration. Research staff will provide 2 in-home training sessions (2 weeks apart) on how to use Stepping Online's fall prevention features (described under the "Arms and Intervention" section). Participants can call the technical support phone line for more help.
   2. Control arm: Stepping On graduates in this arm will not receive Stepping Online.
   3. Neither the intervention nor the control arm subjects will have access to Stepping Online after the 6-month trial.
4. Participants in both study arms will complete measurements at their workshop location or another location that is private and convenient fir subjects at baseline (prior to randomization), and later at 3 and 6 months.

Eligibility criteria: List of Inclusion Criteria:

1. 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.
2. 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.

List of Exclusion Criteria:

1. Leaders/Peer Leaders:

   1. Not available to participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
   2. Not in the area at the end of the 6-month trial.
2. Stepping On Participants/Graduates:

   1. Unable participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
   2. 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

Primary outcomes:
measure: Change of Number of Falls From Baseline to 6 Months
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Number of Tandem Walk Errors at 3 Months and 6 Months
timeFrame: up to 6 months
measure: Gait Speed at 3 Months and 6 Months
timeFrame: up to 6 months
measure: Short Physical Performance Battery (SPPB): Total Balance Test
timeFrame: up to 6 months
measure: Short Physical Performance Battery (SPPB): Gait Speed Test
timeFrame: 6 months
measure: Short Physical Performance Battery (SPPB): Chair Stand Test
timeFrame: up to 6 months
measure: Short Physical Performance Battery (SPPB): Summary Score
timeFrame: up to 6 months
measure: Falls Behavioral Risk Scale (FaB)
timeFrame: up to 6 months
measure: Revised UCLA Loneliness Scale (R-UCLA)
timeFrame: up to 6 months
measure: T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument
timeFrame: up to 6 months
measure: T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument
timeFrame: up to 6 months
measure: Physical Activity Barriers Self-Efficacy Score
timeFrame: up to 6 months
measure: Global Rating of Change Score at 6 Months
timeFrame: 6 months
measure: Balance Exercise Adherence at 3 and 6 Months
timeFrame: up to 6 months
measure: Strength Exercise Adherence at 3 and 6 Months
timeFrame: up to 6 months
measure: Social Bonding Score at 3 Months and 6 Months
timeFrame: up to 6 months
measure: Encouragement to do Exercises Score at 3 Months and 6 Months
timeFrame: up to 6 months
measure: Activities Balance Confidence (ABC) Scale at 3 and 6 Months
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Jane E Mahoney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.