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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
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 10, 2015
Last Updated
March 10, 2016
Sponsor
Rutgers, The State University of New Jersey
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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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