NCT02368899

Brief Summary

This project expands upon the proof-of-concept work done under the pilot project in order to get Interventionaire© poised for more widespread use. Interventionaire© is designed to deploy a computerized interactive questionnaire to patients in a physician waiting room. The information gathered is intended to be a conversation starter for primary care providers and patients (who may feel more at ease with the computer in revealing health risk behaviors, like alcohol abuse). Widespread use of Interventionaire© could result in a substantial cost savings by delivering a wide reaching and highly acceptable prevention strategy for integrating risky health behavior screening and brief intervention into mainstream medical practice.The investigators overall hypothesis is that participants receiving the computerized intervention will have greater improvement than those receiving the attention control condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

February 1, 2015

Last Update Submit

May 8, 2017

Conditions

Alcoholism

Keywords

technologyinformation sciencehealth care

Outcome Measures

Primary Outcomes (1)

  • Change in drinking behavior as measured by self-reported alcohol use after completing the computerized alcohol misuse intervention (CAMI)

    At one month, the investigators expect the attention control group (A) to reduce their alcohol use somewhat, but the intervention group (B) is expected to show a much steeper reduction. Thus, the investigators first planned contrast tests A vs. B, and can be considered similar to a parallel group trial examining 1-month outcomes for intervention vs. attention control. After the cross-over at 1 month, the magnitude of the reduction from Month 1 to Month 2 for those receiving the intervention (C) is expected to be similar to that experienced by those who received the intervention initially.

    Month 1 and Month 2

Secondary Outcomes (1)

  • Changes in participant motivation to stop or cut down alcohol use as measured by self-reported interest in reduction of alcohol use after completing the computerized alcohol misuse intervention (CAMI)

    Month 1 and Month 2

Study Arms (2)

Computerized Alcohol Misuse Intervention

EXPERIMENTAL

Arm 1 is a cross-over randomized controlled trial (XRCT) comparing the short-term effects of the computerized alcohol misuse intervention (CAMI) vs. a generic health education attention-control (AC) condition in reducing past 30 day: (a) days of alcohol use, (b) days of heavy episodic drinking, (c) typical number of drinks consumed on a day of drinking, and (d) alcohol use in dangerous situations; (2) investigate changes in (a) patient motivation and (b) perceived norms as mediators of intervention effectiveness.

Other: Computerized Alcohol Misuse Intervention

Attention Control (AC)

PLACEBO COMPARATOR

Arm 2 is not an active intervention but an attention control condition - it is not expected to exert any real intervention effect. Hence, any observed effects for the AC condition can be attributed to natural change via regression-to-the-mean, assessment reactivity, or a placebo effect. The effect size estimate of the intervention, both from an efficacy standpoint (i.e., above and beyond what change would have normally occurred) and an effectiveness standpoint (i.e., the magnitude of behavior change that can be expected in real-world implementation), can be readily calculated.

Other: Attention Control (AC)

Interventions

Computerized Alcohol Misuse InterventionOTHER

Interventionaire© is a computerized alcohol misuse intervention that includes a normative feedback component unique in its micro-targeting of alcohol use feedback based on participant demographic characteristics (race/ethnicity, gender, and age), drawing population normative data from the National Surveys on Drug Use and Health. This represents a novel use of epidemiological data to inform clinical services.

Also known as: Interventionaire©
Computerized Alcohol Misuse Intervention
Attention Control (AC)OTHER

These products are designed for entertainment and educational purposes only. No medical claims are made for them and, the participant's interaction with them should be conceptually unrelated to alcohol use behavior.In order to avoid any carryover effect from comparing two active treatments, we have chosen to use a simple attention control condition that is not expected to exert any real intervention effect. In that way, the effect size estimate of the intervention can be readily calculated. No research data will be collected as part of the AC, beyond the amount of time spent on the program.

Also known as: RoboMemo, Luminosity, etc.
Attention Control (AC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult age 18 and older;
  • Positive AUDIT screening score; and
  • Willing to provide contact information for themselves and two friends or family members (to assist with tracking for follow-up).

You may not qualify if:

  • Inability to give informed consent (e.g., due to cognitive impairment);
  • Acute medical or psychiatric problem that precludes ability to complete the study interview or intervention;
  • Inability to comprehend or read English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Centers of Baltimore

Baltimore, Maryland, 21225, United States

Location

Related Publications (1)

  • Neighbors C, Larimer ME, Lewis MA. Targeting misperceptions of descriptive drinking norms: efficacy of a computer-delivered personalized normative feedback intervention. J Consult Clin Psychol. 2004 Jun;72(3):434-47. doi: 10.1037/0022-006X.72.3.434.

    PMID: 15279527BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Diana H Caldwell, PhD

    Research Circle Associates

    PRINCIPAL INVESTIGATOR

  • Arti P Varanasi, PhD, MPH

    Advancing Synergy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

February 1, 2015

First Posted

February 23, 2015

Study Start

November 1, 2016

Primary Completion

April 17, 2017

Study Completion

April 17, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)