NCT02970461

Brief Summary

A randomized controlled trial design is used to test the efficacy of gamification elements to drive user behavior in a personal health record.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

November 15, 2016

Last Update Submit

November 17, 2016

Conditions

Chronic Disease

Keywords

personal health recordgamificationchronic patient care

Outcome Measures

Primary Outcomes (1)

  • Change in Number of Completed Fields

    See "Completed" and "EHR/PHR Personal data set" in Study Detailed Description for more information.

    Measured at baseline, 30 days after and 6 months after

Secondary Outcomes (2)

  • Change in Number of Corrected Fields

    Measured at baseline, 30 days after and 6 months after

  • Change in Number of Validated Fields

    Measured at baseline, 30 days after and 6 months after

Study Arms (2)

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.

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.

Other: Gamified Group

Interventions

Gamified GroupOTHER

See Gamified Group in Arms description.

Gamified Group
Control GroupOTHER

See Control Group in Arms description.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires, Gascon 450

Buenos Aires, Argentina

Location

Related Publications (13)

  • 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.

    PMID: 24477621BACKGROUND

  • Tang 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.

    PMID: 16357345BACKGROUND

  • Jci. Joint Commission International Accreditation Standards for Hospitals. Jt Comm Resour Inc. 2013;5th Ed. doi:10.1017/CBO9781107415324.004.

    BACKGROUND

  • 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.

    PMID: 17238444BACKGROUND

  • Tenforde 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.

    PMID: 21557106BACKGROUND

  • Kaelber 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.

    PMID: 18756002BACKGROUND

  • Wells 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.

    PMID: 25326601BACKGROUND

  • Deterding 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

  • 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.

    PMID: 25654660BACKGROUND

  • King 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.

    PMID: 23481424BACKGROUND

  • McKeown 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.

    PMID: 26872801BACKGROUND

  • Ryan 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.

    PMID: 11392867BACKGROUND

  • Mihaly Csikszentmihalyi. 1991. Flow: The psychology of optimal experience. HarperCollins Publishers, New York, New York, USA.

    BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Carlos Bonofiglio, MD

    Hospital Italiano de Buenos Aires

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 22, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

AR(1)