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Completed

NCT Number: NCT02726425

Women in Control: A Virtual World Study of Diabetes Self-Management

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Functionally capable of meeting the activity goals
  • Understand and give informed consent
  • Physician approval to participate in study
  • Can communicate in English or Spanish

Exclusion criteria

  • 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.

Treatment and study plan

Diabetes Self Management Medical Group Visits

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Patient Activation

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Measured by change in PAM 13 score

  2. Medication Adherence

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Prescription fulfillment ratio per i2b2 database claims data analysis

  3. Depression

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Change in Patient Health Questionnaire (PHQ8) score

  4. Improvement in cholesterol, hypertension and body weight

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Serum LDL/HDL from BMC laboratory results. BP from home blood pressure monitor readings. BMI from weight/height measurements.

  5. Health-Related Quality of Life

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Change in Q-LES-Q screening survey

  6. Dietary Habits

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Multiple measures of 24-hr dietary recall

  7. Functional Status

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Measured by Sheehan disability scale

  8. Stress

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Measured by perceived stress scale (PSS-10)

  9. Social Support

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Measured by MOS social support survey

  10. Health Service Utilization

    Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

    Self-report and chart review of hospitalizations, PCP and specialist visits

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Boston University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Massachusetts, Worcester

Registry information

Official study title

Women in Control: A Virtual World Study of Diabetes Self-Management. Translational Research to Improve Diabetes and Obesity Outcomes (R01)

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2016
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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