Diabetes MellitusPRISMNCT01343056
Program Reinforcement Impacts Self Management (PRISM)
A study testing Office Staff Support, Peer Support and Educator Support in people with Diabetes Mellitus, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Office Staff Support, Peer Support and Educator Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person with diabetes referred for diabetes education
Who cannot join
- Gestational diabetes and pregnancy
- If a person has recently had diabetes education, they will not be enrolled in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennsylvania State University
Hershey, Pennsylvania, 17033
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Program Reinforcement Impacts Self Management
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Office Staff Support, Peer Support, Usual Care Support, Educator Support
- Keywords
- Diabetes Self Management Education (DSME), Diabetes, Self Management Support (SMS)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office Staff SupportBehavioural
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 SupportBehavioural
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 SupportBehavioural
Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.
Educator SupportBehavioural
Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.
| Study group | Role | What they receive |
|---|---|---|
| Office Staff follow up education | Active comparator | 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. Receives: Behavioral: Office Staff Support |
| Peer follow up education | Active comparator | 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. Receives: Behavioral: Peer Support |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care Support |
| Educator support follow up | Active comparator | 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. Receives: Behavioral: Educator Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1C, %)
Measured: 6 months
Secondary outcomes (7)
Total Cholesterol (mg/dL)
Measured: 6 months
High Density Lipoprotein (HDL, mg/dL)
Measured: 6 months
Low Density Lipoprotein (LDL, mg/dL)
Measured: 6 months
Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores
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.
Measured: 6 months
Body Mass Index
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.
Measured: 6 months
Diastolic Blood Pressure
Diastolic blood pressure is the pressure when the heart is at rest between beats.
Measured: 6 months
Systolic Blood Pressure
Systolic blood pressure is the pressure when the heart beats while pumping blood.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Linda Siminerio, University of Pittsburgh
- Investigators
- Linda Siminerio, RN, PhD, CDE, Principal investigator, University of PittsburghRobert Gabbay, MD, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343056
- Sponsor's protocol ID
- PRO10090392
- Acronym
- PRISM
- Status last verified
- Mar 2017
- First submitted
- 19 Apr 2011
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23782622
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Reinforcement Impacts Self Management
- ClinicalTrials.gov ID
- NCT01343056
- Acronym / sponsor ID
- PRISM / PRO10090392
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Self Management Education (DSME), Diabetes, Self Management Support (SMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Office Staff follow up education | Active comparator | Behavioral: Office Staff SupportA 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 comparator | Behavioral: Peer SupportA 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 comparator | Behavioral: Usual Care SupportADA 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 comparator | Behavioral: Educator SupportA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A person with diabetes referred for diabetes education
Key exclusion criteria (2 listed)
- Gestational diabetes and pregnancy
- If a person has recently had diabetes education, they will not be enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Office Staff SupportThe 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. | Behavioural | Office Staff follow up education |
| Peer SupportCommunity 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. | Behavioural | Peer follow up education |
| Usual Care SupportDiabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management. | Behavioural | Usual Care |
| Educator SupportDiabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered. | Behavioural | Educator support follow up |
Primary outcome
Hemoglobin A1C (HbA1C, %)
Time frame: 6 months
7 secondary outcomes
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
Body Mass Index
Time frame: 6 months
Diastolic Blood Pressure
Time frame: 6 months
Systolic Blood Pressure
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23782622Siminerio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Siminerio, RN, PhD, CDE principal investigator
University of Pittsburgh
Robert Gabbay, MD, PhD principal investigator
Penn State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Office Staff Support, Peer Support and Educator Support in people with Diabetes Mellitus, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (HbA1C, %) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01343056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.