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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497170
• Other study ID #: PRO201500001877
• Status: Completed
• Phase: N/A
• First received: July 10, 2015
• Last updated: March 10, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Education of goal setting and achievement
Education of American Association of Diabetes Educations 7 behavioral goals and how to achieve them

Locations

Country	Name	City	State
United States	Melissa Souza	Somerdale	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Pre and Post Differences	4 months	No