Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes

Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Education of goal setting and achievement

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somerdale, New Jersey, United States, 08083
      • Melissa Souza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Life style changes; Pre and post after education intervention Education program	Behavioral: Education of goal setting and achievement; Education of American Association of Diabetes Educations 7 behavioral goals and how to achieve them

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Pre and Post Differences	4 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: melissa souza, Rutgers University Newark New Jersey

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PRO201500001877