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Heart DiseaseNCT00790491

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

A study testing guidance tool for providers for lifestyle changes in people with Heart Disease and Diabetes, run by Griffin Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Disease, Diabetes
What is being tested?
guidance tool for providers for lifestyle changes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
Oct 2007to Nov 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients at Staywell Community Health Center, Waterbury CT

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Greater Waterbury Management Resources and Family Care

    Waterbury, Connecticut, 06702

Other trials in United States

About this study

Official title: 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.

Read more

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.

  1. 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.
Being tested
guidance tool for providers for lifestyle changes
Keywords
reduction in risk of heart disease and diabetes
Medical subject headings
Heart Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • guidance tool for providers for lifestyle changesBehavioural

    automated guidance tool for medical providers involved in patient encounters addressing lifestyle changes. Addresses dietary and physical activity. Seeks to reduce cardiac disease risk.

Study groups in NCT00790491
Study groupRoleWhat they receive
Lifestyle counselingExperimentalNot described
Receives: Behavioral: guidance tool for providers for lifestyle changes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data,

    Measured: 2 years

Secondary outcomes (1)
  1. Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790491
Sponsor's protocol ID
2007-11
Status last verified
Nov 2013
First submitted
11 Nov 2008
Last updated
7 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing guidance tool for providers for lifestyle changes in people with Heart Disease and Diabetes, run by Griffin Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data, (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.

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