N/A
N=141
Program Reinforcement Impacts Self Management (PRISM)
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01343056 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Hemoglobin A1C (HbA1C, %) — 6.8; 7.6; 6.8; 7.1 percentage of glycosolated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Office Staff Support (Behavioral); Peer Support (Behavioral); Usual Care Support (Behavioral); Educator Support (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C (HbA1C, %) |
6.8; 7.6; 6.8; 7.1 | — |
| SECONDARY Total Cholesterol (mg/dL) |
169; 159; 175; 150 | — |
| SECONDARY High Density Lipoprotein (HDL, mg/dL) |
46; 46; 39; 39 | — |
| SECONDARY Low Density Lipoprotein (LDL, mg/dL) |
86; 81; 103; 39 | — |
| SECONDARY Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores |
3.9; 4.1; 4.0; 4.5 | — |
| SECONDARY Body Mass Index |
35.1; 31.8; 32.3; 33.9 | — |
| SECONDARY Diastolic Blood Pressure |
78; 78; 78; 75 | — |
| SECONDARY Systolic Blood Pressure |
129; 130; 132; 132 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01343056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.