Clinical trial NCT02823535: Iwin: Individual Well-Being Navigator
Official title: iWin: Navigating Your Path to Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Drug Substance Abuse
Keywords: military
veteran
military spouse
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
Collaborators: name: IMS Health
First posted: 2016-07-06
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. English speaking
2. Between 18 and 54 years of age
3. Member of the U.S. Military (active duty, active reservist), Veteran, Military Spouse (only one member of each household is eligible)
4. Have access to a mobile device with Internet connectivity
5. Comfortable using applications on a mobile device
6. Have access to an email account they check at least weekly.

Exclusion Criteria:

1. Pregnant
2. Significant head injury or other condition that could prevent using mobile device
3. Admitted to an inpatient mental health facility in the past two years
4. Suicidal ideation
5. Moderately severe depression - i.e., score of \> 15 on the Patient Health Questionnaire-8 (PHQ-8)
6. Severe PTSD symptoms (PCL-5 score \> 61).

Primary outcomes:
measure: Health Risk Behaviors Index
timeFrame: Baseline, 6 and 9 months
Secondary outcomes:
measure: The Assist
timeFrame: Baseline, 6 and 9 months
measure: Progress to the Action stage for smoking cessation
timeFrame: Baseline, 6 and 9 months
measure: Change in Well-Being
timeFrame: Baseline, 6 and 9 months
measure: Progress to the Action stage for drinking within recommended limits
timeFrame: Baseline, 6 and 9 months
measure: Progress to the Action stage for meeting national guidelines for physical activity
timeFrame: Baseline, 6 and 9 months
measure: Progress to the Action stage for managing depression
timeFrame: Baseline, 6 and 9 months
measure: Progress to the Action stage for drug use
timeFrame: Baseline, 6 and 9 months
measure: Progress to the Action stage sleep management
timeFrame: Baseline, 6 and 9 months
measure: Progress to the Action stage stress management
timeFrame: Baseline, 6 and 9 months
measure: Change in level of depression
timeFrame: Baseline, 6 and 9 months
measure: WHO-5 Well-being Index
timeFrame: Baseline, 6 and 9 months
measure: Brief Resilience Scale (BRS)
timeFrame: Baseline, 6 and 9 months
Other outcomes:
measure: Personal Financial Wellness Scale™ (PFW Scale™)
timeFrame: Baseline, 6 and 9 months
measure: Mindful Attention Awareness Scale (MAAS), trait version
timeFrame: Baseline, 6 and 9 months
measure: AUDIT-C
timeFrame: Baseline, 6 and 9 months
measure: Personal Wellbeing Index (PWI)
timeFrame: Baseline, 6 and 9 months
measure: Current Tobacco Use Status
timeFrame: Baseline, 6 and 9 months
Locations:
city: Watertown
country: United States
facility: RallyPoint.com
state: Massachusetts
city: Poughkeepsie
country: United States
facility: Military Media Inc.
state: New York
city: South Kingstown
country: United States
facility: Pro-Change Behavior Systems, Inc.
state: Rhode Island
city: Norfolk
country: United States
facility: Pilot Media
state: Virginia
Study officials:
affiliation: Pro-Change Behavior Systems, Inc.
name: Kerry E. Evers, PhD
role: PRINCIPAL_INVESTIGATOR
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