Iwin: Individual Well-Being Navigator
Condition: Other Drug Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The overarching objective of this proposal is to conduct a randomized trial to evaluate the
      effectiveness of the Individual Well-Being Navigator (Iwin) mobile application, a substance
      abuse prevention and well-being enhancement program designed specifically for military
      personnel, veterans, and military spouses. Iwin provides an innovative, tailored mobile
      application using best practices in behavior change science and innovative technology to
      assist users in preventing substance abuse and enhancing well-being by providing them with
      the most appropriate intervention content at the right time. It integrates Transtheoretical
      Model of Behavior Change based tailoring, in app messaging, stage of change matched
      activities, and engaging game-like features in a cutting edge multiple behavior change
      program. The efficacy of the Iwin program will be determined by tests of statistical
      significance indicating that participants in the Treatment condition had lower scores on an
      index of substance use and other behavioral risks. The overall design is a 2 group (treatment
      and control group) by 3 Occasions with repeated measures across occasions.
    

Detailed description: 
      The overarching objective of this project is to conduct a randomized trial to evaluate the
      effectiveness of the Individual Well-Being Navigator (Iwin) mobile application, a substance
      abuse prevention and well-being enhancement program designed specifically for military
      personnel, veterans, and military spouses.

      Military personnel, veterans, and military spouses recruited will be asked to complete a
      series of screening questions on their personal mobile devices. An estimated 476 Personnel
      will need to be screened to arrive at an eligible sample of 238. Randomization of the
      eligible sample will occur within the online baseline assessment at the individual level as
      soon as a participant completes the Informed Consent form. Those randomized to the Control
      Group (n=119) will complete assessments at baseline, 6 months, and 9 months. Additionally,
      the control group will complete a short survey unrelated to the study behaviors at 4 and 5
      months to match incentives given to the intervention group. Those randomized to the
      Intervention Group (n=119) will complete the same schedule of assessments as the control
      group and in addition will have access to the Iwin application (app) in between the baseline
      and 6 month assessments. The assessments include a variety of questions on health, wellness,
      substance use and well-being.

      Users randomized into the intervention group will be able to download the Iwin app for free
      onto their personal device. The Pro-Change Iwin application has been built using the IMS
      Health AppNucleus™ Platform. AppNucleus is a patented, federally certified (FIPS 140-2,
      DIACAP MAC II Sensitive), secure application platform that enables Pro-Change to rapidly
      deploy secure mHealth solutions to users via web portal and commercial mobile technologies
      (such as iOS, Android, Windows Phone, Blackberry). The application provides an innovative,
      tailored program using best practices in behavior change science and innovative technology to
      assist users in preventing substance abuse and enhancing well-being by providing them with
      the most appropriate intervention content at the right time for their individual needs. It
      delivers assessments and tailored feedback immediately on eleven different risk behaviors as
      well as mobile interactive staged matched activities, engaging game-like features and in-app
      notifications on each behavior they are at risk for over the course of 6 months. The app will
      provide reminders for users to return to the program as set time points. Both intervention
      and control participants will receive e-mail reminders to complete follow-up assessments at 6
      and 9 months.

      PRIVACY

      All information shared with us will be kept confidential to the extent provided by law. Names
      will not be connected to survey answers. Instead, a code will be used in place of a name in
      the research study records. Access to the research records will be limited to the research
      study team. The research records will be deleted three years after the submission of the
      final financial report in accordance with OMB Circular A-110.

      To help us protect participant privacy, we have obtained a Certificate of Confidentiality
      from the National Institutes of Health. The researchers can use this Certificate to legally
      refuse to disclose information that may identify a participant in any federal, state, or
      local civil, criminal, administrative, legislative, or other proceedings, for example, if
      there is a court subpoena. The researchers will use the Certificate to resist any demands for
      information that would identify a partcipant. There is one exception to the promise of
      confidentiality: if we see or are told that someone is planning to harm themselves or someone
      else, we will disclose this information to the proper authorities.

      The Certificate cannot be used to resist a demand for information from personnel of the
      United States federal or state government agency sponsoring the project and that will be used
      for auditing or program evaluation of agency funded projects or for information that must be
      disclosed in order to meet the requirements of the federal Food and Drug Administration
      (FDA). A Certificate of Confidentiality does not prevent a participant or a member of their
      family from voluntarily releasing information about the participant or their involvement in
      this research. If an insurer, medical care provider, or other person obtains a participants
      written consent to receive research information, then the researchers will not use the
      Certificate to withhold that information.
    

Intervention name(s): Iwin: Individual Well-Being Navigator
Intervention type(s): Behavioral
Intervention description(s): Immediately following the baseline assessment, the Intervention Group will receive a secure link to download the IWin app. The app provides three types of integrated interventions: 1) stage-matched feedback on the participant's risk behaviors as determined via the assessments; 2) up to two in app messages a day determined by a series of algorithms that control the timing, content, and cadence of the messages; and 3) up to two prompts a week to complete stage-matched activities that foster behavior change (e.g., quizzes, calculators, guided visualizations, info-graphics, testimonials, and more).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: military; veteran; military spouse