Program Reinforcement Impacts Self Management (PRISM) (PRISM)
|ClinicalTrials.gov Identifier: NCT01343056|
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : April 18, 2017
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Behavioral: Office Staff Support Behavioral: Peer Support Behavioral: Usual Care Support Behavioral: Educator Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Program Reinforcement Impacts Self Management|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||October 2013|
Active Comparator: Office Staff follow up education
A 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.
Behavioral: Office Staff Support
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.
Active Comparator: Peer follow up education
A 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.
Behavioral: Peer Support
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.
Active Comparator: Usual Care
ADA 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.
Behavioral: Usual Care Support
Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.
Active Comparator: Educator support follow up
A 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.
Behavioral: Educator Support
Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.
- Hemoglobin A1C (HbA1C, %) [ Time Frame: 6 months ]
- Total Cholesterol (mg/dL) [ Time Frame: 6 months ]
- High Density Lipoprotein (HDL, mg/dL) [ Time Frame: 6 months ]
- Low Density Lipoprotein (LDL, mg/dL) [ Time Frame: 6 months ]
- 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.
- 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.
- Diastolic Blood Pressure [ Time Frame: 6 months ]Diastolic blood pressure is the pressure when the heart is at rest between beats.
- Systolic Blood Pressure [ Time Frame: 6 months ]Systolic blood pressure is the pressure when the heart beats while pumping blood.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343056
|United States, Pennsylvania|
|Pennsylvania State University|
|Hershey, Pennsylvania, United States, 17033|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Linda Siminerio, RN, PhD, CDE||University of Pittsburgh|
|Principal Investigator:||Robert Gabbay, MD, PhD||Penn State University|