The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial (ADAPT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01473654
First received: November 15, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The goal of this randomized control trial is to study the impact of an electronic health record embedded tool's ability to facilitate shared provider-patient goal setting to promote lifestyle behavior change and prevent diabetes in primary care.


Condition Intervention
Prediabetes
Behavioral: ADAPT tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Avoiding Diabetes Thru Action Plan Targeting (ADAPT): A Pilot Randomized Control Trial of an Electronic Medical Record Embedded Prediabetes Shared Goal Setting Tool in Primary Care

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by pedometer


Secondary Outcome Measures:
  • hemoglobin a1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2011
Study Completion Date: April 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADAPT tool
prediabetes counseling using ADAPT tool
Behavioral: ADAPT tool
Use of ADAPT shared goal setting tool in EMR
Other Name: ADAPT
No Intervention: Control

Detailed Description:

The ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial is an innovative study that leverages persuasive technology to enhance the lifestyle behavior change counseling efficacy of primary care providers. Using principles of behavior change theory and persuasion technology, the multidisciplinary design team utilized in-depth interviews and in-vivo usability testing to produce a prototype diabetes prevention counseling system embedded in the electronic health record. The core element of the tool is a streamlined shared goal setting module within the electronic health record system. The system also utilizes a pre-encounter patient behavior change goals elicitation survey to help tailor the goal setting session to patient preferences and encourage shared decision making. The patients also interact with a website that collects their longitudinal behavior change data and visualizes their progress over time and in comparison to other study members. The ADAPT system utilizes the influential powers of goal setting, tailoring, reminders, social comparisons, testimonials and other methods to integrate evidence based behavior change principles and persuasion techniques into routine primary care clinical encounters. If successful, the ADAPT system may represent an adaptable and scalable technology-enabled behavior change tool for all primary care providers.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prediabetes

Exclusion Criteria:

  • age<18
  • diabetes
  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: NCT01473654

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Devin Mann, MD, MS Boston University
  More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01473654     History of Changes
Other Study ID Numbers: H-30397, 5K23DK081665
Study First Received: November 15, 2011
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014