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

This study has been completed.
Sponsor:
Collaborator:
Viocare, Inc
Information provided by (Responsible Party):
Griffin Hospital
ClinicalTrials.gov Identifier:
NCT00790491
First received: November 11, 2008
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 Intervention
Heart Disease
Diabetes
Behavioral: guidance tool for providers for lifestyle changes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Automated Guidance Tool for Medical Encounters Addressing Therapeutic Lifestyle Changes (AuGMEnT)

Resource links provided by NLM:


Further study details as provided by Griffin Hospital:

Primary Outcome Measures:
  • Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data, [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: October 2007
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790491

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

No publications provided

Responsible Party: Griffin Hospital
ClinicalTrials.gov Identifier: NCT00790491     History of Changes
Other Study ID Numbers: 2007-11
Study First Received: November 11, 2008
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Griffin Hospital:
reduction in risk of heart disease and diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014