Other Drug Substance Abuse Clinical Trial
Official title:
iWin: Navigating Your Path to Well-Being
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.
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.
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