Fall Related InjuryNCT02774889
KOSO (Keep On Stepping On)/ Stepping Online
A study testing Stepping Online in people with Fall Related Injury and Social Isolation, run by University of Wisconsin, Madison.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fall Related Injury, Social Isolation
- What is being tested?
- Stepping Online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
List of Inclusion Criteria:
- 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.
List of Exclusion Criteria:
- 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
About this study
Official title: Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet
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.
Read the 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:
- Maintain exercises and fall prevention strategies learned in Stepping On, and
- Stay connected with other participants and leaders/peer leaders in the 7-week workshop.
Approach:
- Subject Eligibility:
- Stepping On leaders and peer leaders of Milwaukee, Dane, Rock, Adams, Green Lake, Marquette and Waushara Counties during the enrollment window
- Stepping On participants/graduates of the above workshops whose leader assesses that they can safely use Stepping Online to exercise at home
- Recruitment and Consenting:
- 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.
- 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.
- Randomization Randomization will occur on the Stepping On workshop level to ensure that leaders, peer leaders and participants are in the same arm. Procedures:
- County liaisons, who routinely collect data, will provide participants' education level (without personal identifiers);
- Study biostatistician pairs workshops based on above data, as well as geographic location and other data to ensure comparability.
- Participants from each designated pair of SO workshops will provide informed consent and participate in baseline measurements
- Designated pair of SO workshops will be randomized to the Stepping Online (intervention) or to the usual care Control arm. <!-- -->
- 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.
- Control arm: Stepping On graduates in this arm will not receive Stepping Online.
- Neither the intervention nor the control arm subjects will have access to Stepping Online after the 6-month trial.
- 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.
- Conditions
- Fall Related Injury, Social Isolation
- Being tested
- Stepping Online
- Keywords
- Falls Prevention, Stepping On, Health Promotion, Implementation, Health Maintenance
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping OnlineBehavioural
Also called Keep On Stepping On (KOSO)
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stepping Online |
| Stepping On Usual Care Control | No intervention | Subjects control workshops in the condition will not have access to Stepping Online. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Number of Falls From Baseline to 6 Months
Number of Falls: monthly calendar self-administered sent and returned via mail
Measured: baseline and 6 months
Secondary outcomes (17)
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.
Measured: up to 6 months
Gait Speed at 3 Months and 6 Months
Observed at baseline, 3 months, 6 months; measured in meters per second over four meters.
Measured: up to 6 months
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.
Measured: up to 6 months
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)
Measured: 6 months
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
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fall Related InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane E Mahoney, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774889
- Sponsor's protocol ID
- 2014-0125
- Other IDs
- A534255, SMPH/MEDICINE/GER-AD DEV
- Status last verified
- Jan 2022
- First submitted
- 11 May 2016
- Last updated
- 31 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22872695Guralnik 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.
PubMed 8126356Hughes 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.
PubMed 18504506Hays 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.
PubMed 19543809Gustafson 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.
PubMed 21804645Clemson 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.
PubMed 15341550Mahoney, 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.
PubMed 39360568
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet
- ClinicalTrials.gov ID
- NCT02774889
- Acronym / sponsor ID
- 2014-0125
- Conditions
- Fall Related Injury, Social Isolation
- Keywords
- Falls Prevention, Stepping On, Health Promotion, Implementation, Health Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Maintain exercises and fall prevention strategies learned in Stepping On, and
- Stay connected with other participants and leaders/peer leaders in the 7-week workshop.
Approach:
- Subject Eligibility:
- Stepping On leaders and peer leaders of Milwaukee, Dane, Rock, Adams, Green Lake, Marquette and Waushara Counties during the enrollment window
- Stepping On participants/graduates of the above workshops whose leader assesses that they can safely use Stepping Online to exercise at home
- Recruitment and Consenting:
- 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.
- 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.
- Randomization Randomization will occur on the Stepping On workshop level to ensure that leaders, peer leaders and participants are in the same arm. Procedures:
- County liaisons, who routinely collect data, will provide participants' education level (without personal identifiers);
- Study biostatistician pairs workshops based on above data, as well as geographic location and other data to ensure comparability.
- Participants from each designated pair of SO workshops will provide informed consent and participate in baseline measurements
- Designated pair of SO workshops will be randomized to the Stepping Online (intervention) or to the usual care Control arm. <!-- -->
- 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.
- Control arm: Stepping On graduates in this arm will not receive Stepping Online.
- Neither the intervention nor the control arm subjects will have access to Stepping Online after the 6-month trial.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepping Online | Active comparator | Behavioral: Stepping OnlineStepping 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. |
| Stepping On Usual Care Control | No intervention | –Subjects control workshops in the condition will not have access to Stepping Online. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepping OnlineAlso: Keep On Stepping On (KOSO)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 | Behavioural | Stepping Online |
Primary outcome
Change of Number of Falls From Baseline to 6 Months
Time frame: baseline and 6 months
Number of Falls: monthly calendar self-administered sent and returned via mail
17 secondary outcomes
Number of Tandem Walk Errors at 3 Months and 6 Months
Time frame: up to 6 months
Gait Speed at 3 Months and 6 Months
Time frame: up to 6 months
Short Physical Performance Battery (SPPB): Total Balance Test
Time frame: up to 6 months
Short Physical Performance Battery (SPPB): Gait Speed Test
Time frame: 6 months
Short Physical Performance Battery (SPPB): Chair Stand Test
Time frame: up to 6 months
Short Physical Performance Battery (SPPB): Summary Score
Time frame: up to 6 months
Falls Behavioral Risk Scale (FaB)
Time frame: up to 6 months
Revised UCLA Loneliness Scale (R-UCLA)
Time frame: up to 6 months
T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument
Time frame: up to 6 months
T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument
Time frame: up to 6 months
Physical Activity Barriers Self-Efficacy Score
Time frame: up to 6 months
Global Rating of Change Score at 6 Months
Time frame: 6 months
Balance Exercise Adherence at 3 and 6 Months
Time frame: up to 6 months
Strength Exercise Adherence at 3 and 6 Months
Time frame: up to 6 months
Social Bonding Score at 3 Months and 6 Months
Time frame: up to 6 months
Encouragement to do Exercises Score at 3 Months and 6 Months
Time frame: up to 6 months
Activities Balance Confidence (ABC) Scale at 3 and 6 Months
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22872695Clemson 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.
- Background: PubMed 8126356Guralnik 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.
- Background: PubMed 18504506Hughes 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.
- Background: PubMed 19543809Hays 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.
- Background: PubMed 21804645Gustafson 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.
- Background: PubMed 15341550Clemson 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.
- BackgroundMahoney, 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.
- Derived from this study: PubMed 39360568Drahota 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane E Mahoney, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Stepping Online in people with Fall Related Injury and Social Isolation, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Number of Falls From Baseline to 6 Months (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774889, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.