Trial Outcomes & Findings for Program Reinforcement Impacts Self Management (PRISM) (NCT NCT01343056)
NCT ID: NCT01343056
Last Updated: 2017-06-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
6 months
Results posted on
2017-06-02
Participant Flow
Participant milestones
| Measure |
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 was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.
|
Peer Follow up of Diabetes Education
A person with diabetes trained as a "peer" met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment.
|
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 was made by a diabetes educator.
|
Educator Support Follow up
A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
32
|
38
|
|
Overall Study
COMPLETED
|
28
|
31
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
3
|
9
|
Reasons for withdrawal
| Measure |
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 was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.
|
Peer Follow up of Diabetes Education
A person with diabetes trained as a "peer" met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment.
|
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 was made by a diabetes educator.
|
Educator Support Follow up
A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
3
|
9
|
Baseline Characteristics
Program Reinforcement Impacts Self Management (PRISM)
Baseline characteristics by cohort
| Measure |
Office Staff Follow up of Diabetes Education
n=35 Participants
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.
|
Peer Follow up of Diabetes Education
n=36 Participants
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.
|
Usual Care
n=32 Participants
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.
|
Educator Support Follow up
n=38 Participants
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.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
141 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
64 years
STANDARD_DEVIATION 10 • n=107 Participants
|
60 years
STANDARD_DEVIATION 12 • n=206 Participants
|
60 years
STANDARD_DEVIATION 10 • n=7 Participants
|
60 years
STANDARD_DEVIATION 10 • n=31 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
36 participants
n=107 Participants
|
32 participants
n=206 Participants
|
38 participants
n=7 Participants
|
141 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=28 Participants
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.
|
Peer Follow up of Diabetes Education
n=31 Participants
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.
|
Usual Care
n=29 Participants
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.
|
Educator Support Follow up
n=29 Participants
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.
|
|---|---|---|---|---|
|
Hemoglobin A1C (HbA1C, %)
|
6.8 percentage of glycosolated hemoglobin
Interval 5.2 to 9.6
|
7.6 percentage of glycosolated hemoglobin
Interval 5.4 to 11.6
|
6.8 percentage of glycosolated hemoglobin
Interval 5.0 to 8.8
|
7.1 percentage of glycosolated hemoglobin
Interval 5.9 to 10.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=28 Participants
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.
|
Peer Follow up of Diabetes Education
n=31 Participants
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.
|
Usual Care
n=29 Participants
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.
|
Educator Support Follow up
n=29 Participants
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.
|
|---|---|---|---|---|
|
Total Cholesterol (mg/dL)
|
169 mg/dL
Interval 100.0 to 205.0
|
159 mg/dL
Interval 121.0 to 369.0
|
175 mg/dL
Interval 129.0 to 321.0
|
150 mg/dL
Interval 27.0 to 210.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=28 Participants
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.
|
Peer Follow up of Diabetes Education
n=31 Participants
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.
|
Usual Care
n=29 Participants
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.
|
Educator Support Follow up
n=29 Participants
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.
|
|---|---|---|---|---|
|
High Density Lipoprotein (HDL, mg/dL)
|
46 mg/dL
Interval 29.0 to 70.0
|
46 mg/dL
Interval 35.0 to 67.0
|
39 mg/dL
Interval 32.0 to 53.0
|
39 mg/dL
Interval 23.0 to 84.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=28 Participants
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.
|
Peer Follow up of Diabetes Education
n=31 Participants
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.
|
Usual Care
n=29 Participants
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.
|
Educator Support Follow up
n=29 Participants
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.
|
|---|---|---|---|---|
|
Low Density Lipoprotein (LDL, mg/dL)
|
86 mg/dL
Interval 36.0 to 139.0
|
81 mg/dL
Interval 59.0 to 274.0
|
103 mg/dL
Interval 38.0 to 203.0
|
39 mg/dL
Interval 23.0 to 84.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=28 Participants
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.
|
Peer Follow up of Diabetes Education
n=31 Participants
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.
|
Usual Care
n=29 Participants
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.
|
Educator Support Follow up
n=29 Participants
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.
|
|---|---|---|---|---|
|
Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores
|
3.9 units on a scale
Standard Deviation .8
|
4.1 units on a scale
Standard Deviation .7
|
4.0 units on a scale
Standard Deviation .9
|
4.5 units on a scale
Standard Deviation .4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=26 Participants
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.
|
Peer Follow up of Diabetes Education
n=25 Participants
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.
|
Usual Care
n=21 Participants
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.
|
Educator Support Follow up
n=25 Participants
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.
|
|---|---|---|---|---|
|
Body Mass Index
|
35.1 kg/m^2
Interval 23.5 to 57.0
|
31.8 kg/m^2
Interval 23.2 to 47.1
|
32.3 kg/m^2
Interval 23.8 to 48.0
|
33.9 kg/m^2
Interval 24.9 to 50.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Diastolic blood pressure is the pressure when the heart is at rest between beats.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=26 Participants
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.
|
Peer Follow up of Diabetes Education
n=25 Participants
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.
|
Usual Care
n=21 Participants
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.
|
Educator Support Follow up
n=26 Participants
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.
|
|---|---|---|---|---|
|
Diastolic Blood Pressure
|
78 mmHg
Interval 50.0 to 109.0
|
78 mmHg
Interval 60.0 to 92.0
|
78 mmHg
Interval 58.0 to 90.0
|
75 mmHg
Interval 60.0 to 92.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Systolic blood pressure is the pressure when the heart beats while pumping blood.
Outcome measures
| Measure |
Office Staff Follow up of Diabetes Education
n=26 Participants
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.
|
Peer Follow up of Diabetes Education
n=25 Participants
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.
|
Usual Care
n=21 Participants
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.
|
Educator Support Follow up
n=26 Participants
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.
|
|---|---|---|---|---|
|
Systolic Blood Pressure
|
129 mmHg
Interval 108.0 to 155.0
|
130 mmHg
Interval 112.0 to 156.0
|
132 mmHg
Interval 102.0 to 150.0
|
132 mmHg
Interval 110.0 to 158.0
|
Adverse Events
Office Staff Follow up of Diabetes Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Follow up of Diabetes Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Educator Support Follow up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place