Trial Outcomes & Findings for Diabetes Outcomes and Unmet Resources (NCT NCT03950973)
NCT ID: NCT03950973
Last Updated: 2024-05-02
Results Overview
HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage. The change in HbA1c from baseline to 12 months is reported here as the primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
667 participants
Primary outcome timeframe
Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Results posted on
2024-05-02
Participant Flow
After screening eligible and consenting to participate, 67 participants either later changed their mind and declined to participate prior to starting data collection, were unreachable for baseline collection, or did not complete baseline in order to be randomized.
Participant milestones
| Measure |
CareAvenue (Intervention)
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Overall Study
STARTED
|
301
|
299
|
|
Overall Study
Follow Up 1 Completion
|
206
|
258
|
|
Overall Study
Follow Up 2 Completion
|
196
|
239
|
|
Overall Study
COMPLETED
|
196
|
239
|
|
Overall Study
NOT COMPLETED
|
105
|
60
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Several participants refused to answer survey questions on race and ethnicity
Baseline characteristics by cohort
| Measure |
CareAvenue (Intervention)
n=301 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=299 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.64 years
STANDARD_DEVIATION 13.68 • n=301 Participants
|
54.26 years
STANDARD_DEVIATION 12.33 • n=299 Participants
|
53.45 years
STANDARD_DEVIATION 1304 • n=600 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
168 Participants
n=301 Participants
|
166 Participants
n=299 Participants
|
334 Participants
n=600 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
132 Participants
n=301 Participants
|
132 Participants
n=299 Participants
|
264 Participants
n=600 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
1 Participants
n=301 Participants
|
1 Participants
n=299 Participants
|
2 Participants
n=600 Participants
|
|
Race/Ethnicity, Customized
Race · Non-Hispanic White
|
204 Participants
n=300 Participants • Several participants refused to answer survey questions on race and ethnicity
|
184 Participants
n=298 Participants • Several participants refused to answer survey questions on race and ethnicity
|
388 Participants
n=598 Participants • Several participants refused to answer survey questions on race and ethnicity
|
|
Race/Ethnicity, Customized
Race · Non-Hispanic Black
|
43 Participants
n=300 Participants • Several participants refused to answer survey questions on race and ethnicity
|
58 Participants
n=298 Participants • Several participants refused to answer survey questions on race and ethnicity
|
101 Participants
n=598 Participants • Several participants refused to answer survey questions on race and ethnicity
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
16 Participants
n=300 Participants • Several participants refused to answer survey questions on race and ethnicity
|
15 Participants
n=298 Participants • Several participants refused to answer survey questions on race and ethnicity
|
31 Participants
n=598 Participants • Several participants refused to answer survey questions on race and ethnicity
|
|
Race/Ethnicity, Customized
Race · Asian
|
9 Participants
n=300 Participants • Several participants refused to answer survey questions on race and ethnicity
|
14 Participants
n=298 Participants • Several participants refused to answer survey questions on race and ethnicity
|
23 Participants
n=598 Participants • Several participants refused to answer survey questions on race and ethnicity
|
|
Race/Ethnicity, Customized
Race · Multiple Race
|
22 Participants
n=300 Participants • Several participants refused to answer survey questions on race and ethnicity
|
20 Participants
n=298 Participants • Several participants refused to answer survey questions on race and ethnicity
|
42 Participants
n=598 Participants • Several participants refused to answer survey questions on race and ethnicity
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=300 Participants • Several participants refused to answer survey questions on race and ethnicity
|
7 Participants
n=298 Participants • Several participants refused to answer survey questions on race and ethnicity
|
13 Participants
n=598 Participants • Several participants refused to answer survey questions on race and ethnicity
|
|
Region of Enrollment
United States
|
301 Participants
n=301 Participants
|
299 Participants
n=299 Participants
|
600 Participants
n=600 Participants
|
|
Income as percent of poverty level
Less than 100%
|
35 Participants
n=297 Participants • Several participants refused to answer survey question about income
|
38 Participants
n=296 Participants • Several participants refused to answer survey question about income
|
73 Participants
n=593 Participants • Several participants refused to answer survey question about income
|
|
Income as percent of poverty level
100-200%
|
52 Participants
n=297 Participants • Several participants refused to answer survey question about income
|
43 Participants
n=296 Participants • Several participants refused to answer survey question about income
|
95 Participants
n=593 Participants • Several participants refused to answer survey question about income
|
|
Income as percent of poverty level
201-400%
|
131 Participants
n=297 Participants • Several participants refused to answer survey question about income
|
130 Participants
n=296 Participants • Several participants refused to answer survey question about income
|
261 Participants
n=593 Participants • Several participants refused to answer survey question about income
|
|
Income as percent of poverty level
Greater than 400%
|
79 Participants
n=297 Participants • Several participants refused to answer survey question about income
|
85 Participants
n=296 Participants • Several participants refused to answer survey question about income
|
164 Participants
n=593 Participants • Several participants refused to answer survey question about income
|
|
Type of diabetes
Type 1
|
61 Participants
n=301 Participants
|
69 Participants
n=299 Participants
|
130 Participants
n=600 Participants
|
|
Type of diabetes
Type 2
|
240 Participants
n=301 Participants
|
230 Participants
n=299 Participants
|
470 Participants
n=600 Participants
|
|
Number of chronic conditions
|
4.12 number of chronic conditions
STANDARD_DEVIATION 2.31 • n=301 Participants
|
4.18 number of chronic conditions
STANDARD_DEVIATION 2.31 • n=299 Participants
|
4.15 number of chronic conditions
STANDARD_DEVIATION 2.31 • n=600 Participants
|
|
Health Insurance Type
None
|
2 Participants
n=301 Participants
|
9 Participants
n=299 Participants
|
11 Participants
n=600 Participants
|
|
Health Insurance Type
Private
|
132 Participants
n=301 Participants
|
128 Participants
n=299 Participants
|
260 Participants
n=600 Participants
|
|
Health Insurance Type
Medicare
|
19 Participants
n=301 Participants
|
25 Participants
n=299 Participants
|
44 Participants
n=600 Participants
|
|
Health Insurance Type
Medicaid
|
45 Participants
n=301 Participants
|
34 Participants
n=299 Participants
|
79 Participants
n=600 Participants
|
|
Health Insurance Type
Medicare + Medicaid Supplemental
|
34 Participants
n=301 Participants
|
30 Participants
n=299 Participants
|
64 Participants
n=600 Participants
|
|
Health Insurance Type
Medicare + Private Supplemental
|
68 Participants
n=301 Participants
|
72 Participants
n=299 Participants
|
140 Participants
n=600 Participants
|
|
Health Insurance Type
Other
|
1 Participants
n=301 Participants
|
1 Participants
n=299 Participants
|
2 Participants
n=600 Participants
|
PRIMARY outcome
Timeframe: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)Population: Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness, unable to obtain measurement, etc.
HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage. The change in HbA1c from baseline to 12 months is reported here as the primary outcome.
Outcome measures
| Measure |
CareAvenue (Intervention)
n=193 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=233 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Change in HbA1c as Measured by an HbA1c Machine
|
0.07 percentage of average glucose 3 months
Standard Deviation 1.57
|
-0.10 percentage of average glucose 3 months
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)Population: Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness, unable to obtain measurement, etc.
Systolic blood pressure will be measured at baseline, 6 months, and 12 months using an automated blood pressure machine in millimeters of mercury (e.g., 120 mm Hg). The change in systolic blood pressure from baseline to 12 months is reported here as secondary outcome.
Outcome measures
| Measure |
CareAvenue (Intervention)
n=193 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=239 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine
|
-4.00 mmHg
Standard Deviation 18.83
|
-6.00 mmHg
Standard Deviation 19.92
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)Population: Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness
Cost-Related Non-Adherence (CRN) Behaviors related to diabetes will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at diabetes. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Min value of 0, max value of 18, with higher scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome.
Outcome measures
| Measure |
CareAvenue (Intervention)
n=196 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=238 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire
|
-0.45 score on a scale
Standard Deviation 3.52
|
-0.91 score on a scale
Standard Deviation 3.62
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)Population: Change from baseline to 12-month follow-up
Cost-Related Non-Adherence (CRN) Behaviors related to other conditions being managed will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at other health conditions being managed. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Mean values were obtained, with min value of 0, max value of 1, with higher mean scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome.
Outcome measures
| Measure |
CareAvenue (Intervention)
n=196 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=239 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire
|
-0.07 score on a scale
Standard Deviation 0.45
|
-0.06 score on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)Population: Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness
Perceived Financial Burden will be measured at baseline, 6 months, and 12 months by the 11-item measure Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) that were measured on a 5-point scale (0: not at all - 4: very much). The score includes reverse-coding 6-items, summing all items, multiplying sum by 11 and dividing the total by number of items answered. Lower scores indicate higher perceptions of financial burden. (Min value of 0, max value of 44) The change in perceived financial burden (COST measure) from baseline to 12 months is reported here as secondary outcome.
Outcome measures
| Measure |
CareAvenue (Intervention)
n=195 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=238 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)
|
2.01 score on a scale
Standard Deviation 7.47
|
2.74 score on a scale
Standard Deviation 7.36
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)Population: Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness
Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 20 items adapted from the Accountable Health Communities Health-Related Social Needs Screening Tool, the Health Leads Social Needs Screening Toolkit, and the Kaiser Permanente Your Current Life Situation Questionnaire. The item values are binary (yes/no). Higher number of "yes" responses indicates higher number of unmet social risk factors/higher need. (Min value of 0, max value of 20). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome.
Outcome measures
| Measure |
CareAvenue (Intervention)
n=195 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=238 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire
|
-1.05 yes responses
Standard Deviation 3.69
|
-1.48 yes responses
Standard Deviation 4.10
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)Population: Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness
Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 3 items from the Accountable Health Communities Health-Related Social Needs Screening Tool and 1 item adapted from the National Health Interview Survey. The items each have three response options, in which a positive response indicates an unmet social risk factor. Higher scores indicate more unmet social risk factors (min value of 0; max value of 8). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome.
Outcome measures
| Measure |
CareAvenue (Intervention)
n=194 Participants
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=238 Participants
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Change in Unmet Social Risk Factors as Measured by Participant Questionnaire
|
-0.26 units on a scale
Standard Deviation 1.42
|
-0.27 units on a scale
Standard Deviation 1.38
|
Adverse Events
CareAvenue (Intervention)
Serious events: 123 serious events
Other events: 75 other events
Deaths: 2 deaths
Guest Assistance Program (Control)
Serious events: 125 serious events
Other events: 86 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CareAvenue (Intervention)
n=301 participants at risk
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=299 participants at risk
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
5.0%
15/301 • Number of events 19 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
3.3%
10/299 • Number of events 11 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
|
Surgical and medical procedures
Hospitalization
|
4.0%
12/301 • Number of events 13 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
4.0%
12/299 • Number of events 13 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
|
Blood and lymphatic system disorders
Hospitalization
|
0.33%
1/301 • Number of events 1 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
0.67%
2/299 • Number of events 3 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
|
Metabolism and nutrition disorders
Hospitalization
|
1.3%
4/301 • Number of events 4 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
2.0%
6/299 • Number of events 6 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
|
General disorders
Hospitalization
|
3.0%
9/301 • Number of events 11 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
5.0%
15/299 • Number of events 17 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
2.3%
7/301 • Number of events 7 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
1.0%
3/299 • Number of events 3 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
|
General disorders
Death
|
0.66%
2/301 • Number of events 2 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
0.67%
2/299 • Number of events 2 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
|
General disorders
Other Serious Event
|
28.9%
87/301 • Number of events 112 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
33.1%
99/299 • Number of events 140 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
Other adverse events
| Measure |
CareAvenue (Intervention)
n=301 participants at risk
Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks.
CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
|
Guest Assistance Program (Control)
n=299 participants at risk
Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks.
Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
|
|---|---|---|
|
General disorders
Other Non-Serious Adverse Events
|
24.9%
75/301 • Number of events 110 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
28.8%
86/299 • Number of events 105 • Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
Additional Information
Minal R. Patel, Ph.D, M.P.H
University of Michigan School of Public Health, Department of Health Behavior & Health Education
Phone: (734) 763-0087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place