KOSO (Keep On Stepping On)/ Stepping Online

Social Isolation Clinical Trial

Official title: Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fall Related Injury
• Social Isolation

• NCT number: NCT02774889
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Completion date: April 30, 2018