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

• ClinicalTrials.gov Identifier: NCT00790491
• Recruitment Status: Completed
• First Posted: November 13, 2008
• Last Update Posted: November 7, 2013
• Sponsor: Griffin Hospital
• Collaborator: Viocare, Inc.
• Information provided by (Responsible Party): Griffin Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Heart Disease; Diabetes	Behavioral: guidance tool for providers for lifestyle changes	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 240 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Automated Guidance Tool for Medical Encounters Addressing Therapeutic Lifestyle Changes (AuGMEnT)
• Study Start Date: October 2007
• Actual Primary Completion Date: November 2013
• Actual Study Completion Date: November 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data, [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting. [ Time Frame: 2 years ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• adult patients at Staywell Community Health Center, Waterbury CT

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Connecticut

Greater Waterbury Management Resources and Family Care

Waterbury, Connecticut, United States, 06702

Sponsors and Collaborators

Griffin Hospital

Viocare, Inc.

More Information

• Responsible Party: Griffin Hospital
• ClinicalTrials.gov Identifier: NCT00790491
• Other Study ID Numbers: 2007-11
• First Posted: November 13, 2008
• Last Update Posted: November 7, 2013
• Last Verified: November 2013

Keywords provided by Griffin Hospital:

reduction in risk of heart disease and diabetes

Additional relevant MeSH terms:

Heart Diseases; Cardiovascular Diseases