DiabetesNCT02082704
Interactive Spaced Education to Optimize Diabetes Care
A study testing SE Game on DSME and SE Game on American History in people with Diabetes, run by Boston VA Research Institute, Inc. at 1 site in United States.
Trial summary
Investigators are conducting a randomized controlled trial to determine whether an online team-based spaced education (SE) game can improve HbA1c levels among these patients with diabetes (primary aim). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- SE Game on DSME and SE Game on American History
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in the northeastern Veterans Affairs hospital system who are taking oral diabetes medications, have a PPR<80%, and have a HbA1c >7.5.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Investigators are conducting a randomized controlled trial to determine whether an online team-based spaced education (SE) game can improve HbA1c levels among these patients with diabetes (primary aim). Secondary aims include determining the impact of the game on patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine (M/C) ratio, ACE PPR, and ARB PPR.
Read the detailed description
Participants will be randomized to one of two cohorts: (1) the intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history, and (2) the 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME. Each game would consist of 2 questions per week x 25 weeks = 50 questions total per arm. The questions are delivered via email by the Qstream platform to the participants. Upon clicking on a hyperlink in the email, participants select an answer that is downloaded to a server. They are then provided with the answer to and explanation of the question, along with additional educational materials. Using an adaptive methodology, the spacing and content of the game material will be individualized for each clinician based on their performance. Home-based testing of HbA1c and M/C ratio will be conducted by patients at enrollment, 6 months and 12 months. If successful, this SE game will improve diabetes management among VA patients and improve patient outcomes. Given the growing use of email and the Internet by patients, SE games could be easily expanded to a broad audience of VA patients with varying health problems across the country. With content tailored to meet specific needs, SE games can be utilized as tools to improve patients' clinical outcomes by bolstering their health management behaviors.
- Conditions
- Diabetes
- Being tested
- SE Game on DSME, SE Game on American History
- Keywords
- Diabetes, Education, Patient, Educational Technology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SE Game on DSMEBehavioural
Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.
SE Game on American HistoryBehavioural
Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.
| Study group | Role | What they receive |
|---|---|---|
| SE Game on DSME | Experimental | The intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history, Receives: Behavioral: SE Game on DSME |
| SE Game on American History | Active comparator | The 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME. Receives: Behavioral: SE Game on American History |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels
Measured: Months 1-12
Secondary outcomes (16)
Microalbumenuria levels [microalbumin-creatinine ratio].
Measured: Months 1-12
Pill possession ratios of oral diabetes medications.
Measured: Months 1-12
Treatment with angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
Measured: Months 1-12
Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
Measured: Months 1-12
Weight / BMI
Measured: Months 1-12
Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol & triglyceride levels,
Measured: Months 1-12
Systolic and diastolic blood pressure.
Measured: Months 1-12
Clinic visit frequency.
Measured: Months 1-12
Initiation or alteration of insulin therapy
Measured: Months 1-12
Changes in oral diabetes medication regimen.
Measured: Months 1-12
Patient-perceived empowerment to manage their diabetes.
Questionnaire
Measured: Months 1-12
Baseline knowledge levels of patients assessed via their initial responses to SE game questions -- DSME SE game cohort only.
Measured: Months 1-6
Analysis of SE game performance differences by patient-related variables (age, gender, geographic location, baseline HbA1c, etc.) -- DSME SE game cohort only.
Measured: Months 1-6
Patient-perceived acceptability of SE game interventions.
Questionnaire
Measured: Months 1-6
Patient-perceived barriers and facilitators to the SE game intervention.
Questionnaire
Measured: Months 1-6
Patient's perceptions of the optimal parameters for the SE game intervention.
Questionnaire
Measured: Months 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionNov 2016
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 DiabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- B. Price Kerfoot, MD EdM, Principal investigator, VA Boston Healthcare SystemPaul R. Conlin, MD, Principal investigator, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082704
- Sponsor's protocol ID
- AHRQ 1R01HS019708-01A1
- Status last verified
- Jul 2017
- First submitted
- 4 Mar 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kerfoot BP, Gagnon DR, McMahon GT, Orlander JD, Kurgansky KE, Conlin PR. A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Sep;40(9):1218-1225. doi: 10.2337/dc17-0310. Epub 2017 Aug 8.
PubMed 28790131
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Spaced Education to Optimize Diabetes Care
- ClinicalTrials.gov ID
- NCT02082704
- Acronym / sponsor ID
- AHRQ 1R01HS019708-01A1
- Conditions
- Diabetes
- Keywords
- Diabetes, Education, Patient, Educational Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Mar 2014 (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.
Investigators are conducting a randomized controlled trial to determine whether an online team-based spaced education (SE) game can improve HbA1c levels among these patients with diabetes (primary aim). Secondary aims include determining the impact of the game on patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine (M/C) ratio, ACE PPR, and ARB PPR.
Detailed description
Participants will be randomized to one of two cohorts: (1) the intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history, and (2) the 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME. Each game would consist of 2 questions per week x 25 weeks = 50 questions total per arm. The questions are delivered via email by the Qstream platform to the participants. Upon clicking on a hyperlink in the email, participants select an answer that is downloaded to a server. They are then provided with the answer to and explanation of the question, along with additional educational materials. Using an adaptive methodology, the spacing and content of the game material will be individualized for each clinician based on their performance. Home-based testing of HbA1c and M/C ratio will be conducted by patients at enrollment, 6 months and 12 months. If successful, this SE game will improve diabetes management among VA patients and improve patient outcomes. Given the growing use of email and the Internet by patients, SE games could be easily expanded to a broad audience of VA patients with varying health problems across the country. With content tailored to meet specific needs, SE games can be utilized as tools to improve patients' clinical outcomes by bolstering their health management behaviors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SE Game on DSME | Experimental | Behavioral: SE Game on DSMEThe intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history, |
| SE Game on American History | Active comparator | Behavioral: SE Game on American HistoryThe 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in the northeastern Veterans Affairs hospital system who are taking oral diabetes medications, have a PPR<80%, and have a HbA1c >7.5.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SE Game on DSMEInvestigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior. | Behavioural | SE Game on DSME |
| SE Game on American HistoryInvestigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior. | Behavioural | SE Game on American History |
Primary outcome
HbA1c levels
Time frame: Months 1-12
16 secondary outcomes
Microalbumenuria levels [microalbumin-creatinine ratio].
Time frame: Months 1-12
Pill possession ratios of oral diabetes medications.
Time frame: Months 1-12
Treatment with angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
Time frame: Months 1-12
Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
Time frame: Months 1-12
Weight / BMI
Time frame: Months 1-12
Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol & triglyceride levels,
Time frame: Months 1-12
Systolic and diastolic blood pressure.
Time frame: Months 1-12
Clinic visit frequency.
Time frame: Months 1-12
Initiation or alteration of insulin therapy
Time frame: Months 1-12
Changes in oral diabetes medication regimen.
Time frame: Months 1-12
Patient-perceived empowerment to manage their diabetes.
Time frame: Months 1-12
Baseline knowledge levels of patients assessed via their initial responses to SE game questions -- DSME SE game cohort only.
Time frame: Months 1-6
Analysis of SE game performance differences by patient-related variables (age, gender, geographic location, baseline HbA1c, etc.) -- DSME SE game cohort only.
Time frame: Months 1-6
Patient-perceived acceptability of SE game interventions.
Time frame: Months 1-6
Patient-perceived barriers and facilitators to the SE game intervention.
Time frame: Months 1-6
Patient's perceptions of the optimal parameters for the SE game intervention.
Time frame: Months 1-6
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 12 Jul 2017.
- Derived from this study: PubMed 28790131Kerfoot BP, Gagnon DR, McMahon GT, Orlander JD, Kurgansky KE, Conlin PR. A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Sep;40(9):1218-1225. doi: 10.2337/dc17-0310. Epub 2017 Aug 8.
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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.
B. Price Kerfoot, MD EdM principal investigator
VA Boston Healthcare System
Paul R. Conlin, MD principal investigator
VA Boston Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SE Game on DSME and SE Game on American History in people with Diabetes, run by Boston VA Research Institute, Inc. 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 1 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 12 Jul 2017. 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?
HbA1c levels (time frame: Months 1-12). 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 NCT02082704, 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 12 Jul 2017.