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Program Reinforcement Impacts Self Management (PRISM)

Program Reinforcement Impacts Self Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01343056
Acronym
PRISM
Enrollment
141
Registered
2011-04-27
Start date
2011-04-30
Completion date
2013-10-31
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes Self Management Education (DSME), Diabetes, Self Management Support (SMS)

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.

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.

Interventions

BEHAVIORALOffice 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.

BEHAVIORALPeer 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.

Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.

BEHAVIORALEducator Support

Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.

Sponsors

Penn State University
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hemoglobin A1C (HbA1C, %)6 months

Secondary

MeasureTime frameDescription
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) Scores6 monthsThe 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.
Total Cholesterol (mg/dL)6 months
Diastolic Blood Pressure6 monthsDiastolic blood pressure is the pressure when the heart is at rest between beats.
Systolic Blood Pressure6 monthsSystolic blood pressure is the pressure when the heart beats while pumping blood.
Body Mass Index6 monthsBody 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
35
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.
36
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.
32
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.
38
Total141

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up7539

Baseline characteristics

CharacteristicPeer Follow up of Diabetes EducationUsual CareOffice Staff Follow up of Diabetes EducationEducator Support Follow upTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
36 Participants32 Participants35 Participants38 Participants141 Participants
Age, Continuous64 years
STANDARD_DEVIATION 10
60 years
STANDARD_DEVIATION 12
60 years
STANDARD_DEVIATION 13.4
60 years
STANDARD_DEVIATION 10
60 years
STANDARD_DEVIATION 10
Region of Enrollment
United States
36 participants32 participants35 participants38 participants141 participants
Sex: Female, Male
Female
19 Participants16 Participants25 Participants20 Participants80 Participants
Sex: Female, Male
Male
17 Participants16 Participants10 Participants18 Participants61 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 350 / 360 / 320 / 38
serious
Total, serious adverse events
0 / 350 / 360 / 320 / 38

Outcome results

Primary

Hemoglobin A1C (HbA1C, %)

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEDIAN)
Office Staff Follow up of Diabetes EducationHemoglobin A1C (HbA1C, %)6.8 percentage of glycosolated hemoglobin
Peer Follow up of Diabetes EducationHemoglobin A1C (HbA1C, %)7.6 percentage of glycosolated hemoglobin
Usual CareHemoglobin A1C (HbA1C, %)6.8 percentage of glycosolated hemoglobin
Educator Support Follow upHemoglobin A1C (HbA1C, %)7.1 percentage of glycosolated hemoglobin
Secondary

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.

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEDIAN)
Office Staff Follow up of Diabetes EducationBody Mass Index35.1 kg/m^2
Peer Follow up of Diabetes EducationBody Mass Index31.8 kg/m^2
Usual CareBody Mass Index32.3 kg/m^2
Educator Support Follow upBody Mass Index33.9 kg/m^2
Secondary

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.

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEAN)Dispersion
Office Staff Follow up of Diabetes EducationChange in Diabetes Empowerment Scale- Short Form (DES-SF) Scores3.9 units on a scaleStandard Deviation 0.8
Peer Follow up of Diabetes EducationChange in Diabetes Empowerment Scale- Short Form (DES-SF) Scores4.1 units on a scaleStandard Deviation 0.7
Usual CareChange in Diabetes Empowerment Scale- Short Form (DES-SF) Scores4.0 units on a scaleStandard Deviation 0.9
Educator Support Follow upChange in Diabetes Empowerment Scale- Short Form (DES-SF) Scores4.5 units on a scaleStandard Deviation 0.4
Secondary

Diastolic Blood Pressure

Diastolic blood pressure is the pressure when the heart is at rest between beats.

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEDIAN)
Office Staff Follow up of Diabetes EducationDiastolic Blood Pressure78 mmHg
Peer Follow up of Diabetes EducationDiastolic Blood Pressure78 mmHg
Usual CareDiastolic Blood Pressure78 mmHg
Educator Support Follow upDiastolic Blood Pressure75 mmHg
Secondary

High Density Lipoprotein (HDL, mg/dL)

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEDIAN)
Office Staff Follow up of Diabetes EducationHigh Density Lipoprotein (HDL, mg/dL)46 mg/dL
Peer Follow up of Diabetes EducationHigh Density Lipoprotein (HDL, mg/dL)46 mg/dL
Usual CareHigh Density Lipoprotein (HDL, mg/dL)39 mg/dL
Educator Support Follow upHigh Density Lipoprotein (HDL, mg/dL)39 mg/dL
Secondary

Low Density Lipoprotein (LDL, mg/dL)

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEDIAN)
Office Staff Follow up of Diabetes EducationLow Density Lipoprotein (LDL, mg/dL)86 mg/dL
Peer Follow up of Diabetes EducationLow Density Lipoprotein (LDL, mg/dL)81 mg/dL
Usual CareLow Density Lipoprotein (LDL, mg/dL)103 mg/dL
Educator Support Follow upLow Density Lipoprotein (LDL, mg/dL)39 mg/dL
Secondary

Systolic Blood Pressure

Systolic blood pressure is the pressure when the heart beats while pumping blood.

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEDIAN)
Office Staff Follow up of Diabetes EducationSystolic Blood Pressure129 mmHg
Peer Follow up of Diabetes EducationSystolic Blood Pressure130 mmHg
Usual CareSystolic Blood Pressure132 mmHg
Educator Support Follow upSystolic Blood Pressure132 mmHg
Secondary

Total Cholesterol (mg/dL)

Time frame: 6 months

Population: Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.

ArmMeasureValue (MEDIAN)
Office Staff Follow up of Diabetes EducationTotal Cholesterol (mg/dL)169 mg/dL
Peer Follow up of Diabetes EducationTotal Cholesterol (mg/dL)159 mg/dL
Usual CareTotal Cholesterol (mg/dL)175 mg/dL
Educator Support Follow upTotal Cholesterol (mg/dL)150 mg/dL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026