Automated Guidance Tool for Medical Encounters Addressing Therapeutic Lifestyle Changes (AuGMEnT).

Automated Guidance Tool for Medical Encounters Addressing Therapeutic Lifestyle Changes (AuGMEnT)

ABSTRACT Although most primary healthcare practitioners recognize the important relationship among nutrition, physical activity and health, few incorporate either dietary or physical activity counseling into routine practice. AUGMENT will employ interactive technology to support effective patient life-style counseling during routine office visits. AUGMENT technology will automate the administration, collection, and analysis of dietary and physical activity questionnaires, and it will guide counseling and present intervention resources and strategies tailored to the patient's unique needs. Using tablet computers, wireless LANs, and inexpensive Internet communications, AUGMENT will have advantages over existing tools: 1.) Lower usage costs (minimal office personal required), 2.) Ability to customize the system, and 3.) Real-time, comprehensive assessment.

The AUGMENT system efficiently and relentlessly gathers important healthcare information (such as total fat, type of fat consumption; fruit and vegetable consumption; fiber and micronutrient intake; and energy output). This means patients are less likely to have their preventive needs overlooked by a busy practitioner. The assessment includes questions to determine the amount of effort the patient will commit to improved health. This will enable the physician to effectively guide the patient via targeted recommendations, obtainable goals, and a course of action that is both preventive and prescriptive; and to monitor progress. Patients who receive objective assessments of their healthcare practices and recommendations based on their own unique health history will be more likely to accept and act on the recommendations.

The specific aims of the study are to: 1) Incorporate key elements of a previously developed prototype tool into a dietary and physical activity risk assessment system, 2) Create a provider training tool to build proficiency in using AUGMENT for counseling to reduce disease risk.

3) Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data, 4) Complete a process evaluation of the AUGMENT program by using it in interventions managed by six physicians with at least 240 patients, and 5) Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting.

Study Overview

• Status: Completed
• Conditions: Diabetes; Heart Disease
• Intervention / Treatment: Behavioral: guidance tool for providers for lifestyle changes

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Waterbury, Connecticut, United States, 06702
      • Greater Waterbury Management Resources and Family Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients at Staywell Community Health Center, Waterbury CT

Exclusion Criteria:

• terminally ill
• pregnant women
• children
• decisionally impaired / dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle counseling	Behavioral: guidance tool for providers for lifestyle changes; automated guidance tool for medical providers involved in patient encounters addressing lifestyle changes. Addresses dietary and physical activity. Seeks to reduce cardiac disease risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data,	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting.	2 years

Collaborators and Investigators

• Sponsor: Griffin Hospital
• Collaborators: Viocare, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 11, 2008
• First Submitted That Met QC Criteria: November 12, 2008
• First Posted (Estimate): November 13, 2008

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: reduction in risk of heart disease and diabetes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 2007-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No