An interventional study of Office Staff Support and Peer Support in Diabetes Mellitus, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-02.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 141 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Office Staff Support
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.
Behavioral: Peer Support
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.
Behavioral: Usual Care Support
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.
Behavioral: Educator 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.
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.
Hemoglobin A1C (HbA1C, %)
Time frame: 6 months
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
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
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
Diastolic Blood Pressure
Diastolic blood pressure is the pressure when the heart is at rest between beats.
Time frame: 6 months
Systolic Blood Pressure
Systolic blood pressure is the pressure when the heart beats while pumping blood.
Time frame: 6 months
| Milestone | 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 |
| Withdrew: Lost to follow-up | 7 | 5 | 3 | 9 |
| percentage of glycosolated hemoglobin | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| Hemoglobin A1C (HbA1C, %) | 6.8 (5.2 to 9.6) | 7.6 (5.4 to 11.6) | 6.8 (5.0 to 8.8) | 7.1 (5.9 to 10.2) |
| mg/dL | Office Staff Follow up Education | Peer Follow up Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| Total Cholesterol (mg/dL) | 169 (100 to 205) | 159 (121 to 369) | 175 (129 to 321) | 150 (27 to 210) |
| mg/dL | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| High Density Lipoprotein (HDL, mg/dL) | 46 (29 to 70) | 46 (35 to 67) | 39 (32 to 53) | 39 (23 to 84) |
| mg/dL | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| Low Density Lipoprotein (LDL, mg/dL) | 86 (36 to 139) | 81 (59 to 274) | 103 (38 to 203) | 39 (23 to 84) |
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.
| units on a scale | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores | 3.9 ± .8 | 4.1 ± .7 | 4.0 ± .9 | 4.5 ± .4 |
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.
| kg/m^2 | Office Staff Follow up Education | Peer Follow up Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| Body Mass Index | 35.1 (23.5 to 57) | 31.8 (23.2 to 47.1) | 32.3 (23.8 to 48) | 33.9 (24.9 to 50.2) |
Diastolic blood pressure is the pressure when the heart is at rest between beats.
| mmHg | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| Diastolic Blood Pressure | 78 (50 to 109) | 78 (60 to 92) | 78 (58 to 90) | 75 (60 to 92) |
Systolic blood pressure is the pressure when the heart beats while pumping blood.
| mmHg | Office Staff Follow up Education | Peer Follow up Education | Usual Care | Educator Support Follow up |
|---|---|---|---|---|
| Systolic Blood Pressure | 129 (108 to 155) | 130 (112 to 156) | 132 (102 to 150) | 132 (110 to 158) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Office Staff Follow up of Diabetes Education | — | 0/35 (0%) | 0/35 (0%) |
| Peer Follow up of Diabetes Education | — | 0/36 (0%) | 0/36 (0%) |
| Usual Care | — | 0/32 (0%) | 0/32 (0%) |
| Educator Support Follow up | — | 0/38 (0%) | 0/38 (0%) |
recruited type 2 diabetes patients who were referred for diabetes education
| Age, Categorical(Participants) | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 36 | 32 | 38 | 141 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up | Total |
|---|---|---|---|---|---|
| Mean | 60 ± 13.4 | 64 ± 10 | 60 ± 12 | 60 ± 10 | 60 ± 10 |
| Sex: Female, Male(Participants) | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up | Total |
|---|---|---|---|---|---|
| Female | 25 | 19 | 16 | 20 | 80 |
| Male | 10 | 17 | 16 | 18 | 61 |
| Region of Enrollment(participants) | Office Staff Follow up of Diabetes Education | Peer Follow up of Diabetes Education | Usual Care | Educator Support Follow up | Total |
|---|---|---|---|---|---|
| United States | 35 | 36 | 32 | 38 | 141 |
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