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Program Reinforcement Impacts Self Management (PRISM) (PRISM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343056
First Posted: April 27, 2011
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Penn State University
Information provided by (Responsible Party):
Linda Siminerio, University of Pittsburgh
Results First Submitted: December 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Diabetes Mellitus
Interventions: Behavioral: Office Staff Support
Behavioral: Peer Support
Behavioral: Usual Care Support
Behavioral: Educator Support

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Office Staff Follow up of Diabetes Education A designee in the office shall be assigned to follow up with the patient for goal attainment. It was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.
Peer Follow up of Diabetes Education A person with diabetes trained as a "peer" met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment.
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 was made by a diabetes educator.
Educator Support Follow up A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.

Participant Flow:   Overall Study
    Office Staff Follow up of Diabetes Education   Peer Follow up of Diabetes Education   Usual Care   Educator Support Follow up
STARTED   35   36   32   38 
COMPLETED   28   31   29   29 
NOT COMPLETED   7   5   3   9 
Lost to Follow-up                7                5                3                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
recruited type 2 diabetes patients who were referred for diabetes education

Reporting Groups
  Description
Office Staff Follow up of Diabetes Education

A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.

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.

Peer Follow up of Diabetes 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 goal attainment.

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.

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.

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.

Educator Support Follow up

A diabetes educator will provide follow up support.

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.

Total Total of all reporting groups

Baseline Measures
   Office Staff Follow up of Diabetes Education   Peer Follow up of Diabetes Education   Usual Care   Educator Support Follow up   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   36   32   38   141 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      35 100.0%      36 100.0%      32 100.0%      38 100.0%      141 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (13.4)   64  (10)   60  (12)   60  (10)   60  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      25  71.4%      19  52.8%      16  50.0%      20  52.6%      80  56.7% 
Male      10  28.6%      17  47.2%      16  50.0%      18  47.4%      61  43.3% 
Region of Enrollment 
[Units: Participants]
         
United States   35   36   32   38   141 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hemoglobin A1C (HbA1C, %)   [ Time Frame: 6 months ]

2.  Secondary:   Total Cholesterol (mg/dL)   [ Time Frame: 6 months ]

3.  Secondary:   High Density Lipoprotein (HDL, mg/dL)   [ Time Frame: 6 months ]

4.  Secondary:   Low Density Lipoprotein (LDL, mg/dL)   [ Time Frame: 6 months ]

5.  Secondary:   Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores   [ Time Frame: 6 months ]

6.  Secondary:   Body Mass Index   [ Time Frame: 6 months ]

7.  Secondary:   Diastolic Blood Pressure   [ Time Frame: 6 months ]

8.  Secondary:   Systolic Blood Pressure   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Linda Siminerio, PhD
Organization: University of Pittsburgh
phone: 412-864-0158
e-mail: simineriol@upmc.edu


Publications:

Responsible Party: Linda Siminerio, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01343056     History of Changes
Other Study ID Numbers: PRO10090392
First Submitted: April 19, 2011
First Posted: April 27, 2011
Results First Submitted: December 7, 2015
Results First Posted: April 18, 2017
Last Update Posted: June 2, 2017