Trial Outcomes & Findings for Clinic to Community Navigation to Improve Diabetes Outcomes (NCT NCT03474731)
NCT ID: NCT03474731
Last Updated: 2024-08-29
Results Overview
Changes in hemoglobin A1c (HbA1c) will be measured with a Bayer DCA 2000+ Analyzer (21), which has a test coefficient of variation \< 5% consistent with requirements of the National Diabetes Data Group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
701 participants
Primary outcome timeframe
Baseline, month 3, month 6, month 9
Results posted on
2024-08-29
Participant Flow
Participants were recruited through churches and organizations in several KY counties in Appalachian Kentucky
59 churches/organizations were randomized once they met the eligibility criteria. One church was never enrolled because it did not meet the eligibility criteria. Two churches/organizations dropped out mainly due to COVID issues.
Unit of analysis: Church/Organization
Participant milestones
| Measure |
Diabetes Self-Management Program (DSMP) Only
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP)Delayed
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
assisting patients in navigation to physician offices, allowing for standard of care to follow.
trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
198 14
|
200 15
|
120 15
|
183 15
|
|
Overall Study
COMPLETED
|
150 14
|
144 13
|
91 15
|
138 15
|
|
Overall Study
NOT COMPLETED
|
48 0
|
56 2
|
29 0
|
45 0
|
Reasons for withdrawal
| Measure |
Diabetes Self-Management Program (DSMP) Only
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP)Delayed
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
assisting patients in navigation to physician offices, allowing for standard of care to follow.
trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
36
|
29
|
11
|
27
|
|
Overall Study
COVID
|
0
|
23
|
0
|
0
|
|
Overall Study
Participant moved from area
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
3
|
18
|
17
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Participant Removed
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Clinic to Community Navigation to Improve Diabetes Outcomes
Baseline characteristics by cohort
| Measure |
Diabetes Self-Management Program (DSMP) Only
n=198 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Delayed
n=200 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=120 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=183 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
Total
n=701 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
63.4 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
449 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
252 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
697 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
189 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
669 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
200 participants
n=7 Participants
|
120 participants
n=5 Participants
|
183 participants
n=4 Participants
|
701 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, month 3, month 6, month 9Population: Number of observations for this particular outcome; i.e., contributed subject-level outcomes; Primary interest for DSMP and Delayed DSMP is baseline to 3 months, after 3 months, the Delayed DSMP group receives DSMP. For the PN and DSMP+PN study design, 9 month data were not collected
Changes in hemoglobin A1c (HbA1c) will be measured with a Bayer DCA 2000+ Analyzer (21), which has a test coefficient of variation \< 5% consistent with requirements of the National Diabetes Data Group.
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=200 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=198 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=120 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=183 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Change in Hemoglobin A1c
baseline to month 3
|
-0.15 percentage of glycated hemoglobin
Standard Error 0.08
|
-0.37 percentage of glycated hemoglobin
Standard Error 0.07
|
-0.31 percentage of glycated hemoglobin
Standard Error 0.12
|
-0.20 percentage of glycated hemoglobin
Standard Error 0.10
|
|
Change in Hemoglobin A1c
baseline to month 6
|
-0.37 percentage of glycated hemoglobin
Standard Error 0.08
|
-0.38 percentage of glycated hemoglobin
Standard Error 0.08
|
-0.21 percentage of glycated hemoglobin
Standard Error 0.14
|
-0.20 percentage of glycated hemoglobin
Standard Error 0.11
|
|
Change in Hemoglobin A1c
baseline to month 9
|
-0.22 percentage of glycated hemoglobin
Standard Error 0.10
|
-0.40 percentage of glycated hemoglobin
Standard Error 0.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, month 9Population: Number of observations for this particular outcome; i.e., contributed subject-level outcomes; Primary interest for DSMP and Delayed DSMP is baseline to 3 months, after 3 months, the Delayed DSMP group receives DSMP. For the PN and DSMP+PN study design, 9 month data were not collected
Change in calculated as a change in weight in kilograms divided by the square of height in meter.
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=200 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=198 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=120 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=183 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Change in Body Mass Index
baseline to month 3
|
-0.23 kg/m2
Standard Error 0.10
|
-0.06 kg/m2
Standard Error 0.10
|
-0.44 kg/m2
Standard Error 0.13
|
-0.14 kg/m2
Standard Error 0.10
|
|
Change in Body Mass Index
baseline to month 6
|
-0.34 kg/m2
Standard Error 0.13
|
-0.05 kg/m2
Standard Error 0.12
|
-0.57 kg/m2
Standard Error 0.21
|
-0.35 kg/m2
Standard Error 0.17
|
|
Change in Body Mass Index
baseline to month 9
|
-0.41 kg/m2
Standard Error 0.14
|
-0.16 kg/m2
Standard Error 0.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, month 9Population: Number of observations for this particular outcome; i.e., contributed subject-level outcomes; Primary interest for DSMP and Delayed DSMP is baseline to 3 months, after 3 months, the Delayed DSMP group receives DSMP. For the PN and DSMP+PN study design, 9 month data were not collected
Change in Waist circumference at the umbilical waist using the Tech-Med model cat. no. 4414.
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=200 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=198 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=119 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=183 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Change in Waist Circumference
baseline to month 3
|
-0.41 inches
Standard Error 0.16
|
-0.25 inches
Standard Error 0.16
|
-0.54 inches
Standard Error 0.22
|
-0.46 inches
Standard Error 0.18
|
|
Change in Waist Circumference
baseline to month 6
|
-0.89 inches
Standard Error 0.18
|
-0.63 inches
Standard Error 0.18
|
-0.63 inches
Standard Error 0.29
|
-0.99 inches
Standard Error 0.23
|
|
Change in Waist Circumference
baseline to month 9
|
-0.73 inches
Standard Error 0.19
|
-1.09 inches
Standard Error 0.19
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants with a PCP that provided data for this outcome. Data only collected at baseline for this measure.
Number of participants with a primary care provider that attended a clinic visit with that provider within the last 3 months.
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=140 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=128 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=83 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=98 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Number of Participants Attending a Clinic Visit
PCP Visit in last 3 months at baseline
|
118 Participants
|
113 Participants
|
70 Participants
|
87 Participants
|
|
Number of Participants Attending a Clinic Visit
No Visit to PCP in last 3 months at baseline
|
22 Participants
|
15 Participants
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, month 9Population: Number of observations for this particular outcome; i.e., contributed subject-level outcomes; Primary interest for DSMP and Delayed DSMP is baseline to 3 months, after 3 months, the Delayed DSMP group receives DSMP. For the PN and DSMP+PN study design, 9 month data were not collected
Change in systolic blood pressure will be reported as the average of two sphygmomanometer readings
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=200 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=198 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=120 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=183 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure
baseline to month 3
|
-0.47 mm Hg
Standard Error 1.58
|
-4.37 mm Hg
Standard Error 1.56
|
-2.97 mm Hg
Standard Error 1.95
|
-3.86 mm Hg
Standard Error 1.56
|
|
Change in Systolic Blood Pressure
baseline to month 6
|
0.46 mm Hg
Standard Error 1.63
|
-4.22 mm Hg
Standard Error 1.59
|
-6.60 mm Hg
Standard Error 2.04
|
-3.56 mm Hg
Standard Error 1.66
|
|
Change in Systolic Blood Pressure
baseline to month 9
|
1.02 mm Hg
Standard Error 1.85
|
-5.85 mm Hg
Standard Error 1.75
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, month 9Population: Number of observations for this particular outcome; i.e., contributed subject-level outcomes; Primary interest for DSMP and Delayed DSMP is baseline to 3 months, after 3 months, the Delayed DSMP group receives DSMP. For the PN and DSMP+PN study design, 9 month data were not collected
Change in diastolic blood pressure will be reported as the average of two sphygmomanometer readings
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=200 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=198 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=120 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=183 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Change in Diastolic Blood Pressure
baseline to month 3
|
-1.60 mm Hg
Standard Error 0.87
|
-2.25 mm Hg
Standard Error 0.86
|
-3.01 mm Hg
Standard Error 1.30
|
-1.12 mm Hg
Standard Error 1.04
|
|
Change in Diastolic Blood Pressure
baseline to month 6
|
-1.69 mm Hg
Standard Error 0.89
|
-1.79 mm Hg
Standard Error 0.87
|
-4.09 mm Hg
Standard Error 1.33
|
-1.07 mm Hg
Standard Error 1.08
|
|
Change in Diastolic Blood Pressure
baseline to month 9
|
-3.57 mm Hg
Standard Error 1.01
|
-2.95 mm Hg
Standard Error 0.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to month 9Population: Data not collected
blood will be drawn and HDL will be measured using a Cholestech LDX point of care machine. Data will be reported as the change in HDL over 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to month 9Population: Data not collected
blood will be drawn and LDL will be measured using a Cholestech LDX point of care machine. Data will be reported as the change in LDL over 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to month 9Population: Data not collected
blood will be drawn and Total cholesterol will be measured using a Cholestech LDX point of care machine. Data will be reported as the change in total cholesterol over 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, month 9Population: Number of observations for this particular outcome; i.e., contributed subject-level outcomes; Primary interest for DSMP and Delayed DSMP is baseline to 3 months, after 3 months, the Delayed DSMP group receives DSMP. For the PN and DSMP+PN study design, 9 month data were not collected
The RAND SF-36 physical component summary (PCS) score is a domain summary score that is part of the 36-Item Short Form Health Survey (SF-36). Scores range from 0 - 100. Higher scores indicate better health or function. The PCS score is calculated by adding up standardized, weighted scores based on eight domains of health, including physical functioning and pain: Limitations in physical activities due to health problems, Bodily pain, and Vitality (energy and fatigue). Specific scoring details are provided in Taft et al. (2001).
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=199 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=197 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=120 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=182 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Change in Physical Component Summary Score of SF-36
baseline to month 3
|
-0.74 score on a scale
Standard Error 0.67
|
0.29 score on a scale
Standard Error 0.64
|
-1.39 score on a scale
Standard Error 0.89
|
1.00 score on a scale
Standard Error 0.70
|
|
Change in Physical Component Summary Score of SF-36
baseline to month 6
|
-0.40 score on a scale
Standard Error 0.71
|
1.00 score on a scale
Standard Error 0.69
|
0.92 score on a scale
Standard Error 0.93
|
1.05 score on a scale
Standard Error 0.75
|
|
Change in Physical Component Summary Score of SF-36
baseline to month 9
|
-1.05 score on a scale
Standard Error 0.79
|
0.28 score on a scale
Standard Error 0.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, month 9Population: Number of observations for this particular outcome; i.e., contributed subject-level outcomes; Primary interest for DSMP and Delayed DSMP is baseline to 3 months, after 3 months, the Delayed DSMP group receives DSMP. For the PN and DSMP+PN study design, 9 month data were not collected
The RAND SF-36 mental component summary (MCS) score is a domain summary score that is part of the 36-Item Short Form Health Survey (SF-36). Scores range from 0 - 100. Higher scores indicating better mental health or function. The MCS score is calculated by adding up standardized, weighted scores based on eight domains of health, including physical functioning and pain: Limitations in physical activities due to health problems, Bodily pain, and Vitality (energy and fatigue). Specific scoring details are provided in Taft et al. (2001).
Outcome measures
| Measure |
Diabetes Self-Management Program (DSMP)Delayed
n=199 Participants
Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview.
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Diabetes Self-Management Program (DSMP) Only
n=197 Participants
Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.
|
Tailored Patient Navigation (PN) Only
n=120 Participants
Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly.
The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.
|
DSMP AND Tailored Patient Navigation
n=182 Participants
Both group education classes and patient navigation
DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.
|
|---|---|---|---|---|
|
Change in Mental Component Summary Score of SF-36
baseline to month 3
|
1.73 score on a scale
Standard Error 0.77
|
1.67 score on a scale
Standard Error 0.74
|
4.24 score on a scale
Standard Error 1.03
|
1.21 score on a scale
Standard Error 0.81
|
|
Change in Mental Component Summary Score of SF-36
baseline to month 6
|
1.66 score on a scale
Standard Error 0.85
|
1.56 score on a scale
Standard Error 0.83
|
4.05 score on a scale
Standard Error 1.10
|
0.92 score on a scale
Standard Error 0.89
|
|
Change in Mental Component Summary Score of SF-36
baseline to month 9
|
1.82 score on a scale
Standard Error 0.89
|
2.67 score on a scale
Standard Error 0.84
|
—
|
—
|
Adverse Events
Diabetes Self-Management Program (DSMP) Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diabetes Self-Management Program (DSMP) Delayed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Tailored Patient Navigation (PN) Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DSMP AND Tailored Patient Navigation
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