Chronic DiseaseNCT02970461
Gamifying Patient's Personal Data Validation and Completion in a Personal Health Record
A study testing Gamified Group in people with Chronic Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
A randomized controlled trial design is used to test the efficacy of gamification elements to drive user behavior in a personal health record. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Gamified Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40,000 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2016to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients enrolled in the Hospital Italiano de Buenos Aires system who are over 18 years old
- Patients who are registered in Hospital Italiano de Buenos Aires' Personal Health Record
- Patients whose use of the Personal Health Record during the previous year exceeds the median of use
Who cannot join
- Refusal to participate or to the informed consent process
- Subjects with a record of Obsessive Compulsive Disorders or related condition as per DSM IV
- Subjects with a record of Neurological conditions that could impair reading (aphasia, dementia, etc)
Trial locations and contacts
1 site in 1 country.
About this study
A randomized controlled trial design is used to test the efficacy of gamification elements to drive user behavior in a personal health record.
Read the detailed description
Electronic personal health record systems (PHRs) support patient centered healthcare by making medical records and other relevant information accessible to patients, thus assisting patients in health self-management[1,2]. The Hospital Italiano de Buenos Aires (HIBA) is a private hospital in Buenos Aires, capital of Argentina. It has 500 beds and serves around 50,000 patients per month. Its main facilities cover a surface area of 78,000 m² (850,000 ft²). The hospital treats both private patients and those derived by social security. It also provides its own Health Maintenance Organization (HMO) being the most important pre-paid healthcare service in Argentina, with about 150,000 clients. HIBA has a Health Information System (HIS) and Electronic Health Records (EHR) since 1998 and implemented a PHR in 2007. The PHR gives patients access to aspects of the EHR related to their Health Care (laboratory, diagnosis, preventive information, medications lists), supports messaging with their physician, scheduling services and medication delivery for Self management, among other things. The majority of HIBA HMO affiliates are enrolled to this PHR. In 2015 HIBA underwent the process of accreditation by the United States Joint Commission[3]. As part of this process, HIBA redefined and refined the EHR/PHR data set, including new fields and regrouping pre-existent ones. EHR/PHR's personal data set is now composed of a series of fields grouped as depicted below. Personal data information is a difficult data set to capture, particularly those regarding social and cultural background information[4]. This data set is not only useful to help better healthcare system management, it is also relevant as it is used for epidemiological and preventive purposes[5-7].
Gamification is a term used to describe using game elements in non-game environments to enhance user experience[8,9]. It has been incorporated with commercial success into several platforms (Linkedin, Badgeville, Facebook). While over the past years gamification elements have been incorporated in healthcare scenarios there is still little evidence on how effective they are[10-12]. Game elements provide engagement consistent with various theories of motivation[13], positive psychology (e.g., flow)[14], and also provide instant feedback. Feedback is more effective when it provides sufficient and specific information for goal achievement and is presented relatively close in time to the event being evaluated. Feedback can reference individual progress, can make social comparisons, or can refer to task criteria.
In order to assess whether gamification is an effective tactic to drive PHR users' behavior, an intervention was designed. The investigators used gamification elements such as points, graphical representations and playful attitude to the design and interactions of the Bio page in the Hospital's PHR. These elements provide instant feedback to user actions. A control group with no game elements will be compared with a gamified group to see if these new game elements would increase patient's personal data rectification, validation and completion in the Hospital's PHR. A status variable was created and assigned to all fields according to the following scheme:
- Completed: user has modified empty field.
- Corrected: user has modified non-empty field.
- Verified: user has updated Group but field data has experienced no change.
- Validated: user has clicked on the "validate" button.
EHR/PHR Personal data set
- Contact Information
- First Name
- Last Name
- Date of Birth
- ID Number
- Nationality
- Citizenship
- Languages Spoken
- Place of Residence
- Street
- Number
- Floor
- Zip Code
- Town
- Province
- Country
- E-mail address
- Phone Numbers
- Home Number
- Work Number
- Fax
- Emergency Contact
- First Name
- Last Name
- Relationship with patient
- Address
- Phone Number
- Billing Information
- Street
- Number
- Floor
- Zip Code
- Town
- Province
- Country
- Social Aspects
- Type of Residence
- Living Situation
- Education
- Highest Academic Degree Achieved
- Cultural Aspects
- Religious Belief
- Special Needs
- Conditions
- Chronic Disease
- Being tested
- Gamified Group, Control Group
- Keywords
- personal health record, gamification, chronic patient care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified GroupOther
See Gamified Group in Arms description.
Control GroupOther
See Control Group in Arms description.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Subjects will see in their Personal Health Record home page a simple text link pointing to their Bio page. Once in their Bio page, the site will display their personal information as usual with the only addition of a "validate data" button next to any non-validated field. The option to edit fields will also be present. Receives: Other: Control Group |
| Gamified Group | Experimental | Subjects will see in their Personal Health Record home page a graphical representation of the percentage of completeness their Bio page has that when clicked acts as a link to their Bio page. Once in their Bio page, the site will display graphical elements such grayed out fields, graphical representations of the percentage of completeness for each data group and on mouse hover over any field a tooltip will inform of what percentage of completeness will be awarded if the data is validated. Also, an addition of a "validate data" button next to any non-validated field. The option to edit fields will also be present. Receives: Other: Gamified Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Completed Fields
See "Completed" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Measured: Measured at baseline, 30 days after and 6 months after
Secondary outcomes (2)
Change in Number of Corrected Fields
See "Corrected" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Measured: Measured at baseline, 30 days after and 6 months after
Change in Number of Validated Fields
See "Validated" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
Measured: Measured at baseline, 30 days after and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Salumedia Tecnologias
- Responsible party
- Sponsor
- Investigators
- Carlos Bonofiglio, MD, Study chair, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970461
- Sponsor's protocol ID
- 2258
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cahill JE, Gilbert MR, Armstrong TS. Personal health records as portal to the electronic medical record. J Neurooncol. 2014 Mar;117(1):1-6. doi: 10.1007/s11060-013-1333-x. Epub 2014 Jan 30.
PubMed 24477621Tang PC, Ash JS, Bates DW, Overhage JM, Sands DZ. Personal health records: definitions, benefits, and strategies for overcoming barriers to adoption. J Am Med Inform Assoc. 2006 Mar-Apr;13(2):121-6. doi: 10.1197/jamia.M2025. Epub 2005 Dec 15.
PubMed 16357345Jci. Joint Commission International Accreditation Standards for Hospitals. Jt Comm Resour Inc. 2013;5th Ed. doi:10.1017/CBO9781107415324.004.
Tang PC, Black W, Young CY. Proposed criteria for reimbursing eVisits: content analysis of secure patient messages in a personal health record system. AMIA Annu Symp Proc. 2006;2006:764-8.
PubMed 17238444Tenforde M, Jain A, Hickner J. The value of personal health records for chronic disease management: what do we know? Fam Med. 2011 May;43(5):351-4.
PubMed 21557106Kaelber DC, Jha AK, Johnston D, Middleton B, Bates DW. A research agenda for personal health records (PHRs). J Am Med Inform Assoc. 2008 Nov-Dec;15(6):729-36. doi: 10.1197/jamia.M2547. Epub 2008 Aug 28.
PubMed 18756002Wells S, Rozenblum R, Park A, Dunn M, Bates DW. Organizational strategies for promoting patient and provider uptake of personal health records. J Am Med Inform Assoc. 2015 Jan;22(1):213-22. doi: 10.1136/amiajnl-2014-003055. Epub 2014 Oct 17.
PubMed 25326601Deterding S, Dixon D, Khaled R, Nacke L, Sicart M, O'Hara K. Gamification: Using Game Design Elements in Non-Game Contexts. Proc 2011 Annu Conf Ext Abstr Hum Factors Comput Syst (CHI 2011). 2011:2425-2428. doi:10.1145/1979742.1979575.
Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.
PubMed 25654660King D, Greaves F, Exeter C, Darzi A. 'Gamification': influencing health behaviours with games. J R Soc Med. 2013 Mar;106(3):76-8. doi: 10.1177/0141076813480996. No abstract available.
PubMed 23481424McKeown S, Krause C, Shergill M, Siu A, Sweet D. Gamification as a strategy to engage and motivate clinicians to improve care. Healthc Manage Forum. 2016 Mar;29(2):67-73. doi: 10.1177/0840470415626528. Epub 2016 Feb 12.
PubMed 26872801Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
PubMed 11392867Mihaly Csikszentmihalyi. 1991. Flow: The psychology of optimal experience. HarperCollins Publishers, New York, New York, USA.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamifying Patient's Personal Data Validation and Completion in a Personal Health Record
- ClinicalTrials.gov ID
- NCT02970461
- Acronym / sponsor ID
- 2258
- Conditions
- Chronic Disease
- Keywords
- personal health record, gamification, chronic patient care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Salumedia Tecnologias
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- 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.
A randomized controlled trial design is used to test the efficacy of gamification elements to drive user behavior in a personal health record.
Detailed description
Electronic personal health record systems (PHRs) support patient centered healthcare by making medical records and other relevant information accessible to patients, thus assisting patients in health self-management[1,2]. The Hospital Italiano de Buenos Aires (HIBA) is a private hospital in Buenos Aires, capital of Argentina. It has 500 beds and serves around 50,000 patients per month. Its main facilities cover a surface area of 78,000 m² (850,000 ft²). The hospital treats both private patients and those derived by social security. It also provides its own Health Maintenance Organization (HMO) being the most important pre-paid healthcare service in Argentina, with about 150,000 clients. HIBA has a Health Information System (HIS) and Electronic Health Records (EHR) since 1998 and implemented a PHR in 2007. The PHR gives patients access to aspects of the EHR related to their Health Care (laboratory, diagnosis, preventive information, medications lists), supports messaging with their physician, scheduling services and medication delivery for Self management, among other things. The majority of HIBA HMO affiliates are enrolled to this PHR. In 2015 HIBA underwent the process of accreditation by the United States Joint Commission[3]. As part of this process, HIBA redefined and refined the EHR/PHR data set, including new fields and regrouping pre-existent ones. EHR/PHR's personal data set is now composed of a series of fields grouped as depicted below. Personal data information is a difficult data set to capture, particularly those regarding social and cultural background information[4]. This data set is not only useful to help better healthcare system management, it is also relevant as it is used for epidemiological and preventive purposes[5-7].
Gamification is a term used to describe using game elements in non-game environments to enhance user experience[8,9]. It has been incorporated with commercial success into several platforms (Linkedin, Badgeville, Facebook). While over the past years gamification elements have been incorporated in healthcare scenarios there is still little evidence on how effective they are[10-12]. Game elements provide engagement consistent with various theories of motivation[13], positive psychology (e.g., flow)[14], and also provide instant feedback. Feedback is more effective when it provides sufficient and specific information for goal achievement and is presented relatively close in time to the event being evaluated. Feedback can reference individual progress, can make social comparisons, or can refer to task criteria.
In order to assess whether gamification is an effective tactic to drive PHR users' behavior, an intervention was designed. The investigators used gamification elements such as points, graphical representations and playful attitude to the design and interactions of the Bio page in the Hospital's PHR. These elements provide instant feedback to user actions. A control group with no game elements will be compared with a gamified group to see if these new game elements would increase patient's personal data rectification, validation and completion in the Hospital's PHR. A status variable was created and assigned to all fields according to the following scheme:
- Completed: user has modified empty field.
- Corrected: user has modified non-empty field.
- Verified: user has updated Group but field data has experienced no change.
- Validated: user has clicked on the "validate" button.
EHR/PHR Personal data set
- Contact Information
- First Name
- Last Name
- Date of Birth
- ID Number
- Nationality
- Citizenship
- Languages Spoken
- Place of Residence
- Street
- Number
- Floor
- Zip Code
- Town
- Province
- Country
- E-mail address
- Phone Numbers
- Home Number
- Work Number
- Fax
- Emergency Contact
- First Name
- Last Name
- Relationship with patient
- Address
- Phone Number
- Billing Information
- Street
- Number
- Floor
- Zip Code
- Town
- Province
- Country
- Social Aspects
- Type of Residence
- Living Situation
- Education
- Highest Academic Degree Achieved
- Cultural Aspects
- Religious Belief
- Special Needs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Control GroupSubjects will see in their Personal Health Record home page a simple text link pointing to their Bio page. Once in their Bio page, the site will display their personal information as usual with the only addition of a "validate data" button next to any non-validated field. The option to edit fields will also be present. |
| Gamified Group | Experimental | Other: Gamified GroupSubjects will see in their Personal Health Record home page a graphical representation of the percentage of completeness their Bio page has that when clicked acts as a link to their Bio page. Once in their Bio page, the site will display graphical elements such grayed out fields, graphical representations of the percentage of completeness for each data group and on mouse hover over any field a tooltip will inform of what percentage of completeness will be awarded if the data is validated. Also, an addition of a "validate data" button next to any non-validated field. The option to edit fields will also be present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients enrolled in the Hospital Italiano de Buenos Aires system who are over 18 years old
- Patients who are registered in Hospital Italiano de Buenos Aires' Personal Health Record
- Patients whose use of the Personal Health Record during the previous year exceeds the median of use
Key exclusion criteria (3 listed)
- Refusal to participate or to the informed consent process
- Subjects with a record of Obsessive Compulsive Disorders or related condition as per DSM IV
- Subjects with a record of Neurological conditions that could impair reading (aphasia, dementia, etc)
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 |
|---|---|---|
| Gamified GroupSee Gamified Group in Arms description. | Other | Gamified Group |
| Control GroupSee Control Group in Arms description. | Other | Control Group |
Primary outcome
Change in Number of Completed Fields
Time frame: Measured at baseline, 30 days after and 6 months after
See "Completed" and "EHR/PHR Personal data set" in Study Detailed Description for more information.
2 secondary outcomes
Change in Number of Corrected Fields
Time frame: Measured at baseline, 30 days after and 6 months after
Change in Number of Validated Fields
Time frame: Measured at baseline, 30 days after and 6 months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 24477621Cahill JE, Gilbert MR, Armstrong TS. Personal health records as portal to the electronic medical record. J Neurooncol. 2014 Mar;117(1):1-6. doi: 10.1007/s11060-013-1333-x. Epub 2014 Jan 30.
- Background: PubMed 16357345Tang PC, Ash JS, Bates DW, Overhage JM, Sands DZ. Personal health records: definitions, benefits, and strategies for overcoming barriers to adoption. J Am Med Inform Assoc. 2006 Mar-Apr;13(2):121-6. doi: 10.1197/jamia.M2025. Epub 2005 Dec 15.
- BackgroundJci. Joint Commission International Accreditation Standards for Hospitals. Jt Comm Resour Inc. 2013;5th Ed. doi:10.1017/CBO9781107415324.004.
- Background: PubMed 17238444Tang PC, Black W, Young CY. Proposed criteria for reimbursing eVisits: content analysis of secure patient messages in a personal health record system. AMIA Annu Symp Proc. 2006;2006:764-8.
- Background: PubMed 21557106Tenforde M, Jain A, Hickner J. The value of personal health records for chronic disease management: what do we know? Fam Med. 2011 May;43(5):351-4.
- Background: PubMed 18756002Kaelber DC, Jha AK, Johnston D, Middleton B, Bates DW. A research agenda for personal health records (PHRs). J Am Med Inform Assoc. 2008 Nov-Dec;15(6):729-36. doi: 10.1197/jamia.M2547. Epub 2008 Aug 28.
- Background: PubMed 25326601Wells S, Rozenblum R, Park A, Dunn M, Bates DW. Organizational strategies for promoting patient and provider uptake of personal health records. J Am Med Inform Assoc. 2015 Jan;22(1):213-22. doi: 10.1136/amiajnl-2014-003055. Epub 2014 Oct 17.
- BackgroundDeterding S, Dixon D, Khaled R, Nacke L, Sicart M, O'Hara K. Gamification: Using Game Design Elements in Non-Game Contexts. Proc 2011 Annu Conf Ext Abstr Hum Factors Comput Syst (CHI 2011). 2011:2425-2428. doi:10.1145/1979742.1979575.
- Background: PubMed 25654660Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.
- Background: PubMed 23481424King D, Greaves F, Exeter C, Darzi A. 'Gamification': influencing health behaviours with games. J R Soc Med. 2013 Mar;106(3):76-8. doi: 10.1177/0141076813480996. No abstract available.
- Background: PubMed 26872801McKeown S, Krause C, Shergill M, Siu A, Sweet D. Gamification as a strategy to engage and motivate clinicians to improve care. Healthc Manage Forum. 2016 Mar;29(2):67-73. doi: 10.1177/0840470415626528. Epub 2016 Feb 12.
- Background: PubMed 11392867Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
- Hospital Italiano de Buenos Aires' websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Bonofiglio, MD study chair
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Group in people with Chronic Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Nov 2016. 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 Argentina. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 in Number of Completed Fields (time frame: Measured at baseline, 30 days after and 6 months after). 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 NCT02970461, which also lists 13 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 22 Nov 2016.