Patient Reported Outcome MeasuresNCT03738254
Motivating Survey Compliance: Game Play Study 1
A study testing The Guardians: A smartphone game, Paper Survey and Electronic Survey in people with Patient Reported Outcome Measures and Compliance, run by Massachusetts Institute of Technology at 1 site in United States.
Trial summary
Self-reports, especially for patients with chronic physical or mental diseases, are critical for disease research and drug development. Historically, it has been very difficult to collect self-reported data for long periods of time as it is an unpleasant and inconvenient task. Read more about this study
- Who is it for?
- Ages 6 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Reported Outcome Measures, Compliance
- What is being tested?
- The Guardians: A smartphone game, Paper Survey and Electronic Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 11 Jan 2018
- 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 6 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 6-24
- Own and use either an iPhone or Android smartphone
- Access to US Apple App Store or US GooglePlayStore
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02142
About this study
Self-reports, especially for patients with chronic physical or mental diseases, are critical for disease research and drug development. Historically, it has been very difficult to collect self-reported data for long periods of time as it is an unpleasant and inconvenient task. Paper and digital surveys are the traditional way of collecting self-reports and have been around for a long time, but still suffer from lack of adherence despite the best efforts of researchers to remind and motivate individuals to fill them out.
Mobile games, on the other hand, benefit from an enormous amount of human adherence. These video games can be played on a smartphone and have captured the attention of a wide variety of demographics. The investigators have used established game design principles to develop a mobile game to motivate individuals to fill out a daily survey.
The purpose of this study is to determine which method of survey administration (paper, digital survey, or game- motivated survey) leads to the highest adherence rates for daily surveys.
Read the detailed description
The recruitment flyers, emails, and postings will invite eligible individuals to participate in a 35-day study about mood, games, and time use for $100. Interested persons will be invited to go to a link to fill out a screening survey. Potential participants will be screened to make sure they are in the appropriate age range and have a smartphone. This will be accomplished via an online survey.
Once a potential participant has been identified, he or she will be directed to digital information about the study that is written in an easily understandable format. This information will include the types of questions that will be asked on a daily basis, information about the pre- and post- surveys, information about payment ($40 for finishing the first 4 of 7 surveys and an additional $60 for finishing the post-study survey), and notification that the participant does not need to fill out any question if it makes him/her uncomfortable. If the individual still wants to participate, they will be instructed to enter the email address of a parent or guardian who can provide consent for them. If the individual is 18 years old or older, they will provide their own consent. Individuals under 18 will read and digitally sign an assent form.
After a participant has consented to participate, he or she will be randomized into one of 3 groups for filling out the daily surveys: paper surveys, digital surveys, or game-motivated digital surveys. The participant will then fill out a pre-study survey about general demographics (age, gender), gaming and time use habits, and complete a couple of quick assessments to determine reading level and arithmetic level. Then participants will provide an email address to receive payment at the end of the study. Participants will be reminded of the payment schedule and then be directed to download the free app that matches his or her randomized group. Note that the paper surveys group will visit a webpage that displays a randomized word that he or she will need to write on the paper survey so that we can approximate when the survey was filled out. In addition, the paper surveys group participants will also be directed to print out their surveys for the study.
After the pre-study survey is complete, participants will receive a daily notification from their downloaded app to remember to fill out their survey for the day for 35 days. Each participant will be asked the following 5 questions each day:
- What was your mood during the last 24 hours?
- How many minutes did you spend playing mobile games in the last 24 hours?
- How many times did you watch ads for in-game rewards in the past 24 hours?
- How many minutes did you spend outside in the last 24 hours?
- What has the weather been like in the last 24 hours?
Additionally, participants in the paper survey will be required to write the word that is on the webpage. This allows us to get an approximation of when the paper survey was filled out.
In the digital survey, we will record the time taken to complete each question and the latency between the notification to complete the survey and the actual survey completion. In the game-motivated survey, we will also record the participant's interactions with the game.
Once the 35-day study is over, participants will be sent a link to fill out the post-study survey. Participants in the paper survey group will also be given instructions for returning the forms to us via FedEx (participants will be given $10 to cover any charges incurred for returning the surveys).
Participants will then be sent their compensation in the form they indicated (Amazon Giftcard via email).
Analysis will be completed to compare average completion rates between the three study arms.
- Conditions
- Patient Reported Outcome Measures, Compliance
- Being tested
- The Guardians: A smartphone game, Paper Survey, Electronic Survey
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Guardians: A smartphone gameOther
"The Guardians" is a mix of two popular game genres: idle games (a game that doesn't require constant player input in order to progress in the game, but often progresses exponentially in response to a few user inputs, e.g., Cookie Clicker and Adventure Capitalist) and pet collection games (a game where the player seeks to collect all of the pets in a set, e.g., Pokemon or Neko Atsume). The game gives the player an in-game reward for completing a survey.
Paper SurveyOther
Paper version of daily survey
Electronic SurveyOther
Electronic version of daily survey administered via a smartphone app.
| Study group | Role | What they receive |
|---|---|---|
| Paper PRO | Active comparator | Participants in the Paper PRO arm completed daily patient reported outcome diaries on paper Receives: Other: Paper Survey |
| ePRO | Active comparator | Participants in the ePRO arm completed daily patient reported outcome diaries online via a smartphone app. Receives: Other: Electronic Survey |
| Game-Motivated ePRO | Experimental | Participants in the Game-Motivated ePRO arm completed daily patient reported outcome diaries online via a smartphone app. These participants were also given access to a game that rewarded the participant with an in-game reward that helped the participant complete various in-game quests. Receives: Other: The Guardians: A smartphone game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rates to various methods of daily survey administration
For each study arm, the average adherence rate (computed as the percent of days (out of 35 total) a participant completed 100% of the daily survey questions, averaged over all participants in the study arm) will be computed and compared
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start9 Oct 2017
- Primary completion11 Nov 2017
- Study completion11 Jan 2018
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 Patient Reported Outcome MeasuresStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Rosalind W Picard, ScD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738254
- Sponsor's protocol ID
- 1708061907
- Status last verified
- Feb 2019
- First submitted
- 7 Nov 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taylor S, Ferguson C, Peng F, Schoeneich M, Picard RW. Use of In-Game Rewards to Motivate Daily Self-Report Compliance: Randomized Controlled Trial. J Med Internet Res. 2019 Jan 3;21(1):e11683. doi: 10.2196/11683.
PubMed 30609986
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Survey Compliance: Game Play Study 1
- ClinicalTrials.gov ID
- NCT03738254
- Acronym / sponsor ID
- 1708061907
- Conditions
- Patient Reported Outcome Measures, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 13 Nov 2018 (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.
Self-reports, especially for patients with chronic physical or mental diseases, are critical for disease research and drug development. Historically, it has been very difficult to collect self-reported data for long periods of time as it is an unpleasant and inconvenient task. Paper and digital surveys are the traditional way of collecting self-reports and have been around for a long time, but still suffer from lack of adherence despite the best efforts of researchers to remind and motivate individuals to fill them out.
Mobile games, on the other hand, benefit from an enormous amount of human adherence. These video games can be played on a smartphone and have captured the attention of a wide variety of demographics. The investigators have used established game design principles to develop a mobile game to motivate individuals to fill out a daily survey.
The purpose of this study is to determine which method of survey administration (paper, digital survey, or game- motivated survey) leads to the highest adherence rates for daily surveys.
Detailed description
The recruitment flyers, emails, and postings will invite eligible individuals to participate in a 35-day study about mood, games, and time use for $100. Interested persons will be invited to go to a link to fill out a screening survey. Potential participants will be screened to make sure they are in the appropriate age range and have a smartphone. This will be accomplished via an online survey.
Once a potential participant has been identified, he or she will be directed to digital information about the study that is written in an easily understandable format. This information will include the types of questions that will be asked on a daily basis, information about the pre- and post- surveys, information about payment ($40 for finishing the first 4 of 7 surveys and an additional $60 for finishing the post-study survey), and notification that the participant does not need to fill out any question if it makes him/her uncomfortable. If the individual still wants to participate, they will be instructed to enter the email address of a parent or guardian who can provide consent for them. If the individual is 18 years old or older, they will provide their own consent. Individuals under 18 will read and digitally sign an assent form.
After a participant has consented to participate, he or she will be randomized into one of 3 groups for filling out the daily surveys: paper surveys, digital surveys, or game-motivated digital surveys. The participant will then fill out a pre-study survey about general demographics (age, gender), gaming and time use habits, and complete a couple of quick assessments to determine reading level and arithmetic level. Then participants will provide an email address to receive payment at the end of the study. Participants will be reminded of the payment schedule and then be directed to download the free app that matches his or her randomized group. Note that the paper surveys group will visit a webpage that displays a randomized word that he or she will need to write on the paper survey so that we can approximate when the survey was filled out. In addition, the paper surveys group participants will also be directed to print out their surveys for the study.
After the pre-study survey is complete, participants will receive a daily notification from their downloaded app to remember to fill out their survey for the day for 35 days. Each participant will be asked the following 5 questions each day:
- What was your mood during the last 24 hours?
- How many minutes did you spend playing mobile games in the last 24 hours?
- How many times did you watch ads for in-game rewards in the past 24 hours?
- How many minutes did you spend outside in the last 24 hours?
- What has the weather been like in the last 24 hours?
Additionally, participants in the paper survey will be required to write the word that is on the webpage. This allows us to get an approximation of when the paper survey was filled out.
In the digital survey, we will record the time taken to complete each question and the latency between the notification to complete the survey and the actual survey completion. In the game-motivated survey, we will also record the participant's interactions with the game.
Once the 35-day study is over, participants will be sent a link to fill out the post-study survey. Participants in the paper survey group will also be given instructions for returning the forms to us via FedEx (participants will be given $10 to cover any charges incurred for returning the surveys).
Participants will then be sent their compensation in the form they indicated (Amazon Giftcard via email).
Analysis will be completed to compare average completion rates between the three study arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paper PRO | Active comparator | Other: Paper SurveyParticipants in the Paper PRO arm completed daily patient reported outcome diaries on paper |
| ePRO | Active comparator | Other: Electronic SurveyParticipants in the ePRO arm completed daily patient reported outcome diaries online via a smartphone app. |
| Game-Motivated ePRO | Experimental | Other: The Guardians: A smartphone gameParticipants in the Game-Motivated ePRO arm completed daily patient reported outcome diaries online via a smartphone app. These participants were also given access to a game that rewarded the participant with an in-game reward that helped the participant complete various in-game quests. |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 6-24
- Own and use either an iPhone or Android smartphone
- Access to US Apple App Store or US GooglePlayStore
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| The Guardians: A smartphone game"The Guardians" is a mix of two popular game genres: idle games (a game that doesn't require constant player input in order to progress in the game, but often progresses exponentially in response to a few user inputs, e.g., Cookie Clicker and Adventure Capitalist) and pet collection games (a game where the player seeks to collect all of the pets in a set, e.g., Pokemon or Neko Atsume). The game gives the player an in-game reward for completing a survey. | Other | Game-Motivated ePRO |
| Paper SurveyPaper version of daily survey | Other | Paper PRO |
| Electronic SurveyElectronic version of daily survey administered via a smartphone app. | Other | ePRO |
Primary outcome
Adherence Rates to various methods of daily survey administration
Time frame: 35 days
For each study arm, the average adherence rate (computed as the percent of days (out of 35 total) a participant completed 100% of the daily survey questions, averaged over all participants in the study arm) will be computed and compared
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 22 Feb 2019.
- Derived from this study: PubMed 30609986Taylor S, Ferguson C, Peng F, Schoeneich M, Picard RW. Use of In-Game Rewards to Motivate Daily Self-Report Compliance: Randomized Controlled Trial. J Med Internet Res. 2019 Jan 3;21(1):e11683. doi: 10.2196/11683.
- Individual participant dataSharing planned: No
Related trials for Patient Reported Outcome Measures
Active, not recruitingObservational study
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
Crohn's Disease
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
RecruitingObservational study
Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
Neurofibromatosis 1, Plexiform Neurofibromas
Active, not recruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Breast Cancer
Not yet recruitingObservational study
Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Quality of Life
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.
Rosalind W Picard, ScD principal investigator
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Guardians: A smartphone game, Paper Survey and Electronic Survey in people with Patient Reported Outcome Measures and Compliance, run by Massachusetts Institute of Technology 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 3 inclusion and 1 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 22 Feb 2019. 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?
Adherence Rates to various methods of daily survey administration (time frame: 35 days). 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 NCT03738254, 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 22 Feb 2019.