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Completed

NCT Number: NCT01343056

Program Reinforcement Impacts Self Management (PRISM)

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania State University, Hershey, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Office Staff Support

Behavioral

The intervention includes the Office staff of primary care practices trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.

Peer Support

Behavioral

Community peers trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.

Usual Care Support

Behavioral

Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.

Educator Support

Behavioral

Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.

Primary outcomes

  1. Hemoglobin A1C (HbA1C, %)

    Time frame: 6 months

Secondary outcomes

  1. Total Cholesterol (mg/dL)

    Time frame: 6 months

  2. High Density Lipoprotein (HDL, mg/dL)

    Time frame: 6 months

  3. Low Density Lipoprotein (LDL, mg/dL)

    Time frame: 6 months

  4. Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores

    Time frame: 6 months

    The DES-SF is a validated, 8 item scale that measures the self-efficacy of patients with diabetes. Responses are selected from a 5-point Likert scale (Strongly Disagree (1), Somewhat Disagree (2), Neutral (3), Somewhat Agree (4), Strongly Agree (5)). The scale is scored by averaging the scores of all completed items (sum of scores divided by 8).

    A positive number represents an improvement in overall patient self-efficacy (empowerment) from the baseline score and 6 month follow up time point.

  5. Body Mass Index

    Time frame: 6 months

    Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight.

  6. Diastolic Blood Pressure

    Time frame: 6 months

    Diastolic blood pressure is the pressure when the heart is at rest between beats.

  7. Systolic Blood Pressure

    Time frame: 6 months

    Systolic blood pressure is the pressure when the heart beats while pumping blood.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Penn State University

Registry information

Official study title

Program Reinforcement Impacts Self Management

Acronym: PRISM

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 27, 2011
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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