Program Reinforcement Impacts Self Management (PRISM)

Diabetes Mellitus Clinical Trial

— PRISM  

Official title:

Program Reinforcement Impacts Self Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01343056
• Other study ID #: PRO10090392
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2011
• Last updated: June 13, 2012
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: June 2012
• Source: University of Pittsburgh
• Contact: Linda Siminerio, PhD, CDE
• Phone: 412-864-0157
• Email: simineriol[@]upmc.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Patients who receive DSME (Diabetes Self Management Education) will be enrolled in a 4 arm, randomized study with each group receiving a different method of follow up. The 4 arms will be evaluated based on clinical indicators, goal achievement and patient satisfaction.

Description:

As the diabetes burden worsens, the need for people to become more involved in self-management will increase. Research has demonstrated that diabetes self-management education (DSME) can improve HbA1C levels by 0.76%. While the rates of diabetes are increasing, the numbers of educators available are shrinking. This is a particular hardship in underserved and military communities where the supply of health care providers is already scarce. Our investigative team has led efforts in supporting DSME in the PA state-wide deployment of the Chronic Care Model (CCM) and reported findings nationally on innovative ways to increase the pool of education services by integrating educators into primary care, establishing nurse clinics in underserved communities and demonstrating that an educator position could be sustained by reimbursement. A 0.76% reduction associated to DSME can be considered an enormous benefit and is equivalent to the impact of most pharmacologic treatments for diabetes. Unfortunately, however the benefits of DSME decrease over time. This suggests that sustained improvements require contact and follow-up. SMS is defined as the process of ongoing support of patient self-care, to sustain the gains following DSME. There is often confusion among the terms self-management education (DSME) and self-management support (SMS). DSME is associated with the provision of knowledge and skills training delivered by a health care professional, e.g. nurses, dietitians, etc. SMS is defined as the process of making and refining changes in health care systems (and the community) to support patient self-care and maintain the gains made following DSME. We know that SMS is currently provided by diabetes educators, but only one 3-6 month follow up is usual care. It has been suggested that SMS can be provided by community workers, peers with diabetes, and office staff within community sites, like PCP offices, and wellness centers, etc. The National Standards for DSME and American Diabetes Association (ADA) Education Recognition Program (ERP) require that SMS approaches be delivered and documented, yet no evidence has been provided to define who should deliver it and how often. This uncertainty has led to many programs delivering SMS in an unstructured, non-standardized and at times haphazard fashion. Practical approaches designed for providing SMS have the potential to sustain improvements. The objective of this study is to compare Self-Management Support (SMS) interventions following Diabetes Self-Management Education (DSME) and determine which will be more likely to maintain improvements in behavioral and clinical outcomes following DSME while achieving patient satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A person with diabetes referred for diabetes education

Exclusion Criteria:

• Gestational diabetes and pregnancy

• If a person has recently had diabetes education, they will not be enrolled in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Four different methods of follow up of goal attainment post diabetes education shall be evaluated.
The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.

Locations

Country	Name	City	State
United States	Pennsylvania State University	Hershey	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Which group (of four total groups) has the highest number of patients reach their self-initiated behavioral goals	Diabetes Self Management Education (DSME) is an important part of the treatment for diabetes. Unfortunately, the positive effects of education sometimes wane over time. We are evaluating four distinct methods of follow up for behavior goals set by the participant. We will evaluate success by measuring how many patients in each of the four total groups reach their self-initiated behavioral goals.	6 months	No
Secondary	Improvement of clinical indicator - HbA1C blood test	We will assess this clinical indicator to evaluate improvement in each of the four arms of the study.	6 weeks, 3 months and 6 months.	No
Secondary	Improvement of clinical indicator - lipid panel	We will assess this clinical indicator to evaluate improvement in each of the four arms of the study.	6 weeks, 3 months, and 6 months	No