Diabetes Mellitus
Conditions
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
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.
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.
Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.
Sponsors
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Hemoglobin A1C (HbA1C, %) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) Scores | 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. |
| Total Cholesterol (mg/dL) | 6 months | — |
| Diastolic Blood Pressure | 6 months | Diastolic blood pressure is the pressure when the heart is at rest between beats. |
| Systolic Blood Pressure | 6 months | Systolic blood pressure is the pressure when the heart beats while pumping blood. |
| Body Mass Index | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 5 | 3 | 9 |
Baseline characteristics
| Characteristic | Peer Follow up of Diabetes Education | Usual Care | Office Staff Follow up of Diabetes Education | Educator Support Follow up | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 32 Participants | 35 Participants | 38 Participants | 141 Participants |
| Age, Continuous | 64 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 participants | 32 participants | 35 participants | 38 participants | 141 participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 25 Participants | 20 Participants | 80 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 10 Participants | 18 Participants | 61 Participants |
Adverse events
| Event type | EG000 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 / 35 | 0 / 36 | 0 / 32 | 0 / 38 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 | 0 / 32 | 0 / 38 |
Outcome results
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Office Staff Follow up of Diabetes Education | Hemoglobin A1C (HbA1C, %) | 6.8 percentage of glycosolated hemoglobin |
| Peer Follow up of Diabetes Education | Hemoglobin A1C (HbA1C, %) | 7.6 percentage of glycosolated hemoglobin |
| Usual Care | Hemoglobin A1C (HbA1C, %) | 6.8 percentage of glycosolated hemoglobin |
| Educator Support Follow up | Hemoglobin A1C (HbA1C, %) | 7.1 percentage of glycosolated hemoglobin |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Office Staff Follow up of Diabetes Education | Body Mass Index | 35.1 kg/m^2 |
| Peer Follow up of Diabetes Education | Body Mass Index | 31.8 kg/m^2 |
| Usual Care | Body Mass Index | 32.3 kg/m^2 |
| Educator Support Follow up | Body Mass Index | 33.9 kg/m^2 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Office Staff Follow up of Diabetes Education | Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores | 3.9 units on a scale | Standard Deviation 0.8 |
| Peer Follow up of Diabetes Education | Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores | 4.1 units on a scale | Standard Deviation 0.7 |
| Usual Care | Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores | 4.0 units on a scale | Standard Deviation 0.9 |
| Educator Support Follow up | Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores | 4.5 units on a scale | Standard Deviation 0.4 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Office Staff Follow up of Diabetes Education | Diastolic Blood Pressure | 78 mmHg |
| Peer Follow up of Diabetes Education | Diastolic Blood Pressure | 78 mmHg |
| Usual Care | Diastolic Blood Pressure | 78 mmHg |
| Educator Support Follow up | Diastolic Blood Pressure | 75 mmHg |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Office Staff Follow up of Diabetes Education | High Density Lipoprotein (HDL, mg/dL) | 46 mg/dL |
| Peer Follow up of Diabetes Education | High Density Lipoprotein (HDL, mg/dL) | 46 mg/dL |
| Usual Care | High Density Lipoprotein (HDL, mg/dL) | 39 mg/dL |
| Educator Support Follow up | High Density Lipoprotein (HDL, mg/dL) | 39 mg/dL |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Office Staff Follow up of Diabetes Education | Low Density Lipoprotein (LDL, mg/dL) | 86 mg/dL |
| Peer Follow up of Diabetes Education | Low Density Lipoprotein (LDL, mg/dL) | 81 mg/dL |
| Usual Care | Low Density Lipoprotein (LDL, mg/dL) | 103 mg/dL |
| Educator Support Follow up | Low Density Lipoprotein (LDL, mg/dL) | 39 mg/dL |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Office Staff Follow up of Diabetes Education | Systolic Blood Pressure | 129 mmHg |
| Peer Follow up of Diabetes Education | Systolic Blood Pressure | 130 mmHg |
| Usual Care | Systolic Blood Pressure | 132 mmHg |
| Educator Support Follow up | Systolic Blood Pressure | 132 mmHg |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Office Staff Follow up of Diabetes Education | Total Cholesterol (mg/dL) | 169 mg/dL |
| Peer Follow up of Diabetes Education | Total Cholesterol (mg/dL) | 159 mg/dL |
| Usual Care | Total Cholesterol (mg/dL) | 175 mg/dL |
| Educator Support Follow up | Total Cholesterol (mg/dL) | 150 mg/dL |