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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774889
• Other study ID #: 2014-0125
• Secondary ID: A534255SMPH/MEDI
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 30, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fall Related Injury
• Social Isolation

Intervention

Behavioral:
• 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: Fall prevention tips Fall prevention exercise videos with narrations for proper technique and safety precautions Guest expert videos with online access to the guest expert to ask questions Tools to set exercise goals, get reminders and track progress Access to a fall prevention specialist for personal feedback and suggested group homework Group discussion and messaging (one-to-one and with their fellow Stepping On workshop participants group, or with all Stepping Online participants and leaders) Fall prevention resources

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Tandem Walk Errors at 3 Months and 6 Months	Observed via the Tandem Walk Test at baseline, 3 months, 6 months. Tandem walk errors were the number of errors while walking a four-meter straight line.; Place a line on the floor marking the distance. The heel of one foot should be touching the tip of the toes of the other foot. Count the number of errors (stepping off the straight line, not putting heel to toe, needing to grab for support, significant body lean). Participants can use an assistive device if they normally use one.	up to 6 months
Secondary	Gait Speed at 3 Months and 6 Months	Observed at baseline, 3 months, 6 months; measured in meters per second over four meters.	up to 6 months
Secondary	Short Physical Performance Battery (SPPB): Total Balance Test	Standing feet together (side by side) for 10 seconds, followed by standing with side of one heel touching the big toe of the other foot (semi-tandem) for 10 seconds, followed by standing with the heel of one foot in front of the toes of the other (tandem) for 10 seconds.; Participants are scored either 0 or 1 for each balance exercise with a total possible range from 0-3 where higher scores indicate improved balance.	up to 6 months
Secondary	Short Physical Performance Battery (SPPB): Gait Speed Test	Participant is timed while walking an 8 foot line on the floor.; Scoring is as follows: 0 = could not do; = >5.7 sec (<0.43 m/sec); = 4.1-6.5 sec (0.44-0.60 m/sec); = 3.2-4.0 (0.61-0.77 m/sec); = <3.1 sec (>0.78 m/sec)	6 months
Secondary	Short Physical Performance Battery (SPPB): Chair Stand Test	Participant is timed while attempting to stand up and sit down 5 times from a chair without using their arms.; Scoring is as follows: 0 = unable; = > 16.7 sec; = 16.6-13.7 sec; = 13.6-11.2 sec; = < 11.1 sec	up to 6 months
Secondary	Short Physical Performance Battery (SPPB): Summary Score	The total possible range of scores for the SPPB repeated chair test, gait test, and balance test is 0-12 where higher scores indicate the best performance.	up to 6 months
Secondary	Falls Behavioral Risk Scale (FaB)	The Falls Behavioral Scale is a list of 24 statements that describe things participants do in everyday life.; Participants are to circle 'never', 'sometimes', 'often', 'always' or 'doesn't apply'. Scoring is from 1 (never) to 4 (always) and is reported as the average score where higher scores indicate higher mitigation of fall risk.	up to 6 months
Secondary	Revised UCLA Loneliness Scale (R-UCLA)	A 3-item scale (adapted, short form of the full 20-item scale) designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 3-point Likert scale is used that ask participants to rate each item as either 3 - "I often feel this way", 2 - "I sometimes feel this way", or 1 - "I hardly ever feel this way". Scoring: Items 1-3 are summed and participants are given a composite score of 3-9, with higher scores indicating a greater sense of loneliness.	up to 6 months
Secondary	T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument	The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GMH is 21.2 - 67.6 where higher scores indicate better quality of life.	up to 6 months
Secondary	T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument	The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GPH is 16.2 - 67.7 where higher scores indicate better quality of life.	up to 6 months
Secondary	Physical Activity Barriers Self-Efficacy Score	Self-efficacy to reduce barriers to exercise was measured using a 16-item survey where participants rate their confidence that they could perform falls prevention exercises every day for the next 3 months under various circumstances, from 0% 'not at all confident' to 100% 'very confident'. Scores will be reported from 0-10 with higher scores indicated increased self-efficacy.	up to 6 months
Secondary	Global Rating of Change Score at 6 Months	Measures self-perceived change in balance, quantifying the extent to which a participant's balance has improved or deteriorated in the over time (past 6 months). A single question asks the participant to rate their change in balance inside their house, and a single question asks patients to rate their change in balance outside of their house. A Likert scare of -7 ("a very great deal worse") to +7 ("a very great deal better") is used to rate this perceived change.	6 months
Secondary	Balance Exercise Adherence at 3 and 6 Months	Adherence was assessed at 3 and 6 months as the number of days balance exercises were performed each week.	up to 6 months
Secondary	Strength Exercise Adherence at 3 and 6 Months	Adherence was assessed at 3 and 6 months as the number of days strength exercises were performed each week.	up to 6 months
Secondary	Social Bonding Score at 3 Months and 6 Months	Socialization included the 5-item Social Bonding Scale at all timepoints measured as the summed score on a Likert scale of 0 (not at all) to 4 (very much), range 0-20.	up to 6 months
Secondary	Encouragement to do Exercises Score at 3 Months and 6 Months	Socialization included the feeling Encouraged to Exercise at 3 and 6 months on 1 (very difficult) to 5 (very easy) scale.	up to 6 months
Secondary	Activities Balance Confidence (ABC) Scale at 3 and 6 Months	The ABC instrument measures the confidence of participants from 0% (no confidence) to 100% (completely confident) for activity in a range of conditions. Scoring is from 0-10 where higher numbers are more confidence.	up to 6 months