StrokeBE MobileNCT04607811
Behavioral Economics and Mobility After Stroke (BE Mobile)
A study testing Gamification with social incentives in people with Stroke, run by University of Pennsylvania at 1 site in United States.
Trial summary
In this pilot, randomized controlled trial, the investigators will compare the preliminary effectiveness of a gamification with social incentives 8 week intervention to increase physical activity for adults with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Gamification with social incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 12 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ischemic or hemorrhagic stroke (confirmed with ICD-10 or DRG code) at least 3 months prior to enrollment
- Ability to provide informed consent
- Life Space Assessment mobility level 3
- Ability to ambulate outside of their home (self-reported)
- Owns a smartphone or tablet compatible with required applications for the wearable tracking device
- Sufficient cognitive ability to participate (5-minute Montreal Cognitive Assessment Score ≥ 11 points)
Who cannot join
- Inability to provide informed consent, illiteracy or inability to speak, read, and write English
- Self-reported history of falls within the last 3 months
- Severe cognitive impairment (MoCA score ≤ 10 points)
- Medical condition that may limit participation in physical activity program (e.g. metastatic cancer, end-stage renal disease)
- Currently institutionalized in skilled nursing or long-term care facility
- Baseline step count > 7500/day
- Currently receiving physical therapy services
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Using Behavioral Economics to Improve Mobility for Adults With Stroke
In this pilot, randomized controlled trial, the investigators will compare the preliminary effectiveness of a gamification with social incentives 8 week intervention to increase physical activity for adults with stroke.
Read the detailed description
In this 2 arm randomized trial, the investigators will compare the preliminary effectiveness of a social incentive-based gamification intervention to increase physical activity relative to a control arm among adults with stroke. All participants will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above their baseline and then participate in an 8 week intervention. The gamification arm will be entered into a game with points and levels designed using insights from behavioral economics. They will be asked to select a social support partner who will receive weekly updates on their progress in the game.
- Conditions
- Stroke
- Being tested
- Gamification with social incentives
- Keywords
- physical activity, wearable, gamification
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamification with social incentivesBehavioural
Participants will select a step goal that is 33%, 40%, or 50% above their baseline step value. Participants in this group will participate in a game with points and levels to help motivate participants to meet their daily step goal. Additionally, all participants will identify a support partner to receive weekly updates on their performance and offer positive encouragement to help the participant meet their step goal.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Participants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period. Participants will complete study surveys at baseline and the end of the 8 week intervention. |
| Gamification arm | Experimental | Participants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period. Participants will have a weekly step goal they are encouraged to meet. Participants will engage in a social incentive-based gamification based on points and levels that leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. Participants will receive daily feedback for the step counts and weekly feedback for levels. Participants will be asked to identify a support partner, who will receive weekly reports with the the participant's points and levels balance. Receives: Behavioral: Gamification with social incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily step counts
Change in mean daily steps from baseline
Measured: Intervention weeks 1-8
Secondary outcomes (1)
Daily step counts
Proportion of days participants in the gamification arm met their daily step goal
Measured: Intervention weeks 1-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start16 Nov 2020
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Greysen, MD, MHS, MA, Principal investigator, University of PennsylvaniaKimberly J Waddell, PhD, MS, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607811
- Sponsor's protocol ID
- 843894
- Acronym
- BE Mobile
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waddell KJ, Patel MS, Clark K, Harrington TO, Greysen SR. Leveraging insights from behavioral economics to improve mobility for adults with stroke: Design and rationale of the BE Mobile clinical trial. Contemp Clin Trials. 2021 Aug;107:106483. doi: 10.1016/j.cct.2021.106483. Epub 2021 Jun 12.
PubMed 34129953
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Economics to Improve Mobility for Adults With Stroke
- ClinicalTrials.gov ID
- NCT04607811
- Acronym / sponsor ID
- BE Mobile / 843894
- Conditions
- Stroke
- Keywords
- physical activity, wearable, gamification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot, randomized controlled trial, the investigators will compare the preliminary effectiveness of a gamification with social incentives 8 week intervention to increase physical activity for adults with stroke.
Detailed description
In this 2 arm randomized trial, the investigators will compare the preliminary effectiveness of a social incentive-based gamification intervention to increase physical activity relative to a control arm among adults with stroke. All participants will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above their baseline and then participate in an 8 week intervention. The gamification arm will be entered into a game with points and levels designed using insights from behavioral economics. They will be asked to select a social support partner who will receive weekly updates on their progress in the game.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Participants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period. Participants will complete study surveys at baseline and the end of the 8 week intervention. |
| Gamification arm | Experimental | Behavioral: Gamification with social incentivesParticipants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period. Participants will have a weekly step goal they are encouraged to meet. Participants will engage in a social incentive-based gamification based on points and levels that leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. Participants will receive daily feedback for the step counts and weekly feedback for levels. Participants will be asked to identify a support partner, who will receive weekly reports with the the participant's points and levels balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of ischemic or hemorrhagic stroke (confirmed with ICD-10 or DRG code) at least 3 months prior to enrollment
- Ability to provide informed consent
- Life Space Assessment mobility level 3
- Ability to ambulate outside of their home (self-reported)
- Owns a smartphone or tablet compatible with required applications for the wearable tracking device
Key exclusion criteria (7 listed)
- Inability to provide informed consent, illiteracy or inability to speak, read, and write English
- Self-reported history of falls within the last 3 months
- Severe cognitive impairment (MoCA score ≤ 10 points)
- Medical condition that may limit participation in physical activity program (e.g. metastatic cancer, end-stage renal disease)
- Currently institutionalized in skilled nursing or long-term care facility
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 |
|---|---|---|
| Gamification with social incentivesParticipants will select a step goal that is 33%, 40%, or 50% above their baseline step value. Participants in this group will participate in a game with points and levels to help motivate participants to meet their daily step goal. Additionally, all participants will identify a support partner to receive weekly updates on their performance and offer positive encouragement to help the participant meet their step goal. | Behavioural | Gamification arm |
Primary outcome
Daily step counts
Time frame: Intervention weeks 1-8
Change in mean daily steps from baseline
1 secondary outcome
Daily step counts
Time frame: Intervention weeks 1-8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 34129953Waddell KJ, Patel MS, Clark K, Harrington TO, Greysen SR. Leveraging insights from behavioral economics to improve mobility for adults with stroke: Design and rationale of the BE Mobile clinical trial. Contemp Clin Trials. 2021 Aug;107:106483. doi: 10.1016/j.cct.2021.106483. Epub 2021 Jun 12.
- 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.
Ryan Greysen, MD, MHS, MA principal investigator
University of Pennsylvania
Kimberly J Waddell, PhD, MS study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamification with social incentives in people with Stroke, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Daily step counts (time frame: Intervention weeks 1-8). 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 NCT04607811, which also lists 1 linked publication.
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 16 Sep 2021.