Diabetes MellitusNCT02726425
Women in Control: A Virtual World Study of Diabetes Self-Management
A study testing Diabetes Self Management Medical Group Visits in people with Diabetes Mellitus, run by Boston Medical Center at 1 site in United States.
Trial summary
This study evaluates the comparative effectiveness of a diabetes self management (DSM) group medical visit in the virtual world (Second life) verses a face-to-face format, aimed to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diabetes Self Management Medical Group Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus (documented in the medical chart)
- Last recorded HbA1c >8.0
- Currently treated with diet, oral hypoglycemic agents or insulin
- Black/African American or Hispanic/Latina origin
- Has telephone access
- Able to understand and participate in study protocol
Show all 10Show fewer
- Functionally capable of meeting the activity goals
- Understand and give informed consent
- Physician approval to participate in study
- Can communicate in English or Spanish
Who cannot join
- History of diabetic ketoacidosis
- Currently or planning pregnancy
- Unable or unwilling to provide informed consent
- Plans to leave area within 6 month study period that would interfere with ability to attend 8 weekly sessions and/or 6 month follow up
- Required intermittent glucocorticoid therapy within past 3 months.
- Experienced acute coronary event (myocardial infarction or unsable angina) within previous 6 months
- Medical condition that precludes adherence to study dietary recommendations (i.e. Crohn's, ulcerative colitis, etc)
- Medical or serious psychiatric illness (dementia, suicidal within last 5 months, psychiatric hospitalization). Those with diagnosis of depression or who take antidepressents are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Women in Control: A Virtual World Study of Diabetes Self-Management. Translational Research to Improve Diabetes and Obesity Outcomes (R01)
This study evaluates the comparative effectiveness of a diabetes self management (DSM) group medical visit in the virtual world (Second life) verses a face-to-face format, aimed to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled diabetes mellitus.
Read the detailed description
The prevalence of diabetes mellitus (DM) in the US is disproportionately high among minority women. In order to participate as partners in healthcare, DM patients need self-management education and support. Diabetes self-management (DSM) support is effective in helping DM patients make good choices and achieve clinical goals but is difficult to deliver in medical practice settings. Virtual reality technology can assist DM patients and their clinical teams with DSM support by providing effective educational tools in an engaging, learner-centered context that fosters self-efficacy and skill proficiency. Our prior work demonstrated that virtual worlds, like Second Life (SL), are suitable for supporting DSM education for patients. SL, an Internet-based virtual world, is an example of an immersive, three-dimensional environment which supports social networking and interaction with information.
The investigators now aim to enhance the existing diabetes curriculum using a medical group visit design to study whether the Women in Control virtual world group medical visit leads to similarly effective health and educational outcomes compared to face-to-face group medical visits. The investigators aims are to conduct a randomized, controlled trial of the comparative effectiveness of a virtual world DSM group medical visit format vs. a face-to-face DSM group visit format to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled DM at six month follow up, and to conduct a qualitative, ethnographic study of participant engagement with the virtual world platform during the virtual world group sessions, between group sessions, and following completion of the eight-week curriculum to characterize learners' self-directed interactions with the technology platform and assess the correlation of these interactions with DSM behaviors and diabetes control.
- Conditions
- Diabetes Mellitus
- Being tested
- Diabetes Self Management Medical Group Visits
- Keywords
- Diabetes self management, Second Life platform, Medical group visits
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self Management Medical Group VisitsBehavioural
The Women in Control DSM intervention involves: (1) 8-wk series of interactive, educational medical group visit sessions with groups of 10-12 participants, led by clinicians \& peer leaders lasting ~100'' in length conducted either in Spanish or English and (2) Individual consultation with a clinician lasting 10-15 minutes. Group visits will consist of experiential and discussion based learning of topics including the importance of diet, physical activity, medications, mindfulness and stress reduction to diabetes self management.
| Study group | Role | What they receive |
|---|---|---|
| Second Life Participants | Experimental | Half of participants will receive the Diabetes Self Management Medical Group Visits intervention while meeting in the virtual world (Second Life platform) Receives: Behavioral: Diabetes Self Management Medical Group Visits |
| Face-to-Face Participants | Active comparator | The other half of the participants will receive the Diabetes Self Management Medical Group Visitsintervention while meeting face-to-face in person at Boston Medical Center. Receives: Behavioral: Diabetes Self Management Medical Group Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity level
Participants will wear an activity monitor for a week at each collection point. Results measured in METs/hr.
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Change in disease control (HbA1c)
Change in HbA1c from BMC laboratory blood testing results
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Secondary outcomes (10)
Patient Activation
Measured by change in PAM 13 score
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Medication Adherence
Prescription fulfillment ratio per i2b2 database claims data analysis
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Depression
Change in Patient Health Questionnaire (PHQ8) score
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Improvement in cholesterol, hypertension and body weight
Serum LDL/HDL from BMC laboratory results. BP from home blood pressure monitor readings. BMI from weight/height measurements.
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Health-Related Quality of Life
Change in Q-LES-Q screening survey
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Dietary Habits
Multiple measures of 24-hr dietary recall
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Functional Status
Measured by Sheehan disability scale
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Stress
Measured by perceived stress scale (PSS-10)
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Social Support
Measured by MOS social support survey
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Health Service Utilization
Self-report and chart review of hospitalizations, PCP and specialist visits
Measured: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Boston University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Suzanne E Mitchell, MD, MS, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726425
- Sponsor's protocol ID
- H-34220
- Other IDs
- 1R01DK106531
- Status last verified
- Sep 2020
- First submitted
- 28 Mar 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell SE, Mako M, Sadikova E, Barnes L, Stone A, Rosal MC, Wiecha J. The comparative experiences of women in control: diabetes self-management education in a virtual world. J Diabetes Sci Technol. 2014 Nov;8(6):1185-92. doi: 10.1177/1932296814549829. Epub 2014 Sep 10.
PubMed 25212580Mitchell SE, Bragg A, De La Cruz BA, Winter MR, Reichert MJ, Laird LD, Moldovan IA, Parker KN, Martin-Howard J, Gardiner P. Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial. J Med Internet Res. 2023 May 10;25:e43669. doi: 10.2196/43669.
PubMed 37163341
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women in Control: A Virtual World Study of Diabetes Self-Management. Translational Research to Improve Diabetes and Obesity Outcomes (R01)
- ClinicalTrials.gov ID
- NCT02726425
- Acronym / sponsor ID
- H-34220
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes self management, Second Life platform, Medical group visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Boston University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2015
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 1 Apr 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.
This study evaluates the comparative effectiveness of a diabetes self management (DSM) group medical visit in the virtual world (Second life) verses a face-to-face format, aimed to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled diabetes mellitus.
Detailed description
The prevalence of diabetes mellitus (DM) in the US is disproportionately high among minority women. In order to participate as partners in healthcare, DM patients need self-management education and support. Diabetes self-management (DSM) support is effective in helping DM patients make good choices and achieve clinical goals but is difficult to deliver in medical practice settings. Virtual reality technology can assist DM patients and their clinical teams with DSM support by providing effective educational tools in an engaging, learner-centered context that fosters self-efficacy and skill proficiency. Our prior work demonstrated that virtual worlds, like Second Life (SL), are suitable for supporting DSM education for patients. SL, an Internet-based virtual world, is an example of an immersive, three-dimensional environment which supports social networking and interaction with information.
The investigators now aim to enhance the existing diabetes curriculum using a medical group visit design to study whether the Women in Control virtual world group medical visit leads to similarly effective health and educational outcomes compared to face-to-face group medical visits. The investigators aims are to conduct a randomized, controlled trial of the comparative effectiveness of a virtual world DSM group medical visit format vs. a face-to-face DSM group visit format to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled DM at six month follow up, and to conduct a qualitative, ethnographic study of participant engagement with the virtual world platform during the virtual world group sessions, between group sessions, and following completion of the eight-week curriculum to characterize learners' self-directed interactions with the technology platform and assess the correlation of these interactions with DSM behaviors and diabetes control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second Life Participants | Experimental | Behavioral: Diabetes Self Management Medical Group VisitsHalf of participants will receive the Diabetes Self Management Medical Group Visits intervention while meeting in the virtual world (Second Life platform) |
| Face-to-Face Participants | Active comparator | Behavioral: Diabetes Self Management Medical Group VisitsThe other half of the participants will receive the Diabetes Self Management Medical Group Visitsintervention while meeting face-to-face in person at Boston Medical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with type 2 diabetes mellitus (documented in the medical chart)
- Last recorded HbA1c >8.0
- Currently treated with diet, oral hypoglycemic agents or insulin
- Black/African American or Hispanic/Latina origin
- Has telephone access
Key exclusion criteria (8 listed)
- History of diabetic ketoacidosis
- Currently or planning pregnancy
- Unable or unwilling to provide informed consent
- Plans to leave area within 6 month study period that would interfere with ability to attend 8 weekly sessions and/or 6 month follow up
- Required intermittent glucocorticoid therapy within past 3 months.
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 |
|---|---|---|
| Diabetes Self Management Medical Group VisitsThe Women in Control DSM intervention involves: (1) 8-wk series of interactive, educational medical group visit sessions with groups of 10-12 participants, led by clinicians \& peer leaders lasting ~100'' in length conducted either in Spanish or English and (2) Individual consultation with a clinician lasting 10-15 minutes. Group visits will consist of experiential and discussion based learning of topics including the importance of diet, physical activity, medications, mindfulness and stress reduction to diabetes self management. | Behavioural | Face-to-Face Participants, Second Life Participants |
Primary outcome
Change in physical activity level
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Participants will wear an activity monitor for a week at each collection point. Results measured in METs/hr.
Change in disease control (HbA1c)
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Change in HbA1c from BMC laboratory blood testing results
10 secondary outcomes
Patient Activation
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Medication Adherence
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Depression
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Improvement in cholesterol, hypertension and body weight
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Health-Related Quality of Life
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Dietary Habits
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Functional Status
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Stress
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Social Support
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Health Service Utilization
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
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 4 Sep 2020.
- Background: PubMed 25212580Mitchell SE, Mako M, Sadikova E, Barnes L, Stone A, Rosal MC, Wiecha J. The comparative experiences of women in control: diabetes self-management education in a virtual world. J Diabetes Sci Technol. 2014 Nov;8(6):1185-92. doi: 10.1177/1932296814549829. Epub 2014 Sep 10.
- Derived from this study: PubMed 37163341Mitchell SE, Bragg A, De La Cruz BA, Winter MR, Reichert MJ, Laird LD, Moldovan IA, Parker KN, Martin-Howard J, Gardiner P. Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial. J Med Internet Res. 2023 May 10;25:e43669. doi: 10.2196/43669.
- 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.
Suzanne E Mitchell, MD, MS principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self Management Medical Group Visits in people with Diabetes Mellitus, run by Boston Medical Center 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 10 inclusion and 8 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 4 Sep 2020. 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?
Change in physical activity level (time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up). The study lists 2 primary outcomes in all. 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 NCT02726425, which also lists 2 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 4 Sep 2020.