Program Reinforcement Impacts Self Management (PRISM)
PRISM
1 other identifier
interventional
141
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Apr 2011
Typical duration for not_applicable diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
April 18, 2017
CompletedJune 2, 2017
March 1, 2017
1.7 years
April 19, 2011
December 7, 2015
May 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1C (HbA1C, %)
6 months
Secondary Outcomes (7)
Total Cholesterol (mg/dL)
6 months
High Density Lipoprotein (HDL, mg/dL)
6 months
Low Density Lipoprotein (LDL, mg/dL)
6 months
Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores
6 months
Body Mass Index
6 months
- +2 more secondary outcomes
Study Arms (4)
Office Staff follow up education
ACTIVE COMPARATORA designee in the office staff shall be assigned to follow up with the patient for for behavioral goal setting attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up. The intervention is the follow up goal attainment and office staff have been trained on elements of goal attainment.
Peer follow up education
ACTIVE COMPARATORA person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor behavioral goal attainment.The intervention is the follow up goal attainment and peers have been trained on elements of goal attainment.
Usual Care
ACTIVE COMPARATORADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator. The intervention is the diabetes educator making a phone call to the patient to ask how they are doing.
Educator support follow up
ACTIVE COMPARATORA diabetes educator will provide follow up support and make monthly call to the patient to ascertain behavioral goal setting attainment. The diabetes educator uses behavioral goal setting as an education intervention. The educator calls patient to determine goal attainment. That is the intervention.
Interventions
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.
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.
Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.
Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.
Eligibility Criteria
You may qualify if:
- A person with diabetes referred for diabetes education
You may not qualify if:
- Gestational diabetes and pregnancy
- If a person has recently had diabetes education, they will not be enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Penn State Universitycollaborator
Study Sites (2)
Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Siminerio L, Ruppert KM, Gabbay RA. Who can provide diabetes self-management support in primary care? Findings from a randomized controlled trial. Diabetes Educ. 2013 Sep-Oct;39(5):705-13. doi: 10.1177/0145721713492570. Epub 2013 Jun 19.
PMID: 23782622BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Siminerio, PhD
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Siminerio, RN, PhD, CDE
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Robert Gabbay, MD, PhD
Penn State University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Linda Siminerio, RN, PhD, CDE, Executive Director
Study Record Dates
First Submitted
April 19, 2011
First Posted
April 27, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
October 1, 2013
Last Updated
June 2, 2017
Results First Posted
April 18, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share