Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education of goal setting and achievement
Sponsored by

About this trial
This is an interventional supportive care trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study
- Patients willing to attend minimum of 4 monthly appointments for diabetes treatment
- Patients who give written consent to participate
Exclusion Criteria:
- Patients below age 18, children are not treated in the facility for type 2 diabetes
- Patients who attend less than 4 monthly appointments for diabetes,
- Patients who do no give written consent to participate
Sites / Locations
- Melissa Souza
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Life style changes
Arm Description
Pre and post after education intervention Education program
Outcomes
Primary Outcome Measures
Hemoglobin A1c
Pre and Post Differences
Secondary Outcome Measures
Full Information
NCT ID
NCT02497170
First Posted
July 10, 2015
Last Updated
March 10, 2016
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT02497170
Brief Title
Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
Official Title
Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes
Detailed Description
The Primary Investigator will meet with patients that attend routine visits for Diabetes 2 in the primary care office on a monthly basis to set behavior goals. Behavior goals will be set by patient's choice of 4 out of 7 of the AADE7 recommendations. The goals are health eating, being active, monitoring,taking medications, problem solving, healthy coping, and reducing risk. Once the goal is chosen, the PI and patient will make a plan to address the goals on a monthly basis for four months. There will be pre and post questionnaires that will evaluate diabetes knowledge and self-efficacy. There will also be a pre and post measure of the patient's Hemoglobin A1c which is a measurement that helps determine the extent of glycemic control over a three-month period.
The goal of the study is to determine if translation of the AADE7 behavioral goals into the primary care setting will make a difference in diabetes knowledge, self efficacy, and Hemoglobin A1c.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Life style changes
Arm Type
Other
Arm Description
Pre and post after education intervention Education program
Intervention Type
Behavioral
Intervention Name(s)
Education of goal setting and achievement
Intervention Description
Education of American Association of Diabetes Educations 7 behavioral goals and how to achieve them
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Pre and Post Differences
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study
Patients willing to attend minimum of 4 monthly appointments for diabetes treatment
Patients who give written consent to participate
Exclusion Criteria:
Patients below age 18, children are not treated in the facility for type 2 diabetes
Patients who attend less than 4 monthly appointments for diabetes,
Patients who do no give written consent to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
melissa souza
Organizational Affiliation
Rutgers University Newark New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melissa Souza
City
Somerdale
State/Province
New Jersey
ZIP/Postal Code
08083
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
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