Trial Outcomes & Findings for ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus (NCT NCT02910089)
NCT ID: NCT02910089
Last Updated: 2019-09-17
Results Overview
Pre- to post-intervention change in mean HbA1c levels
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1400 participants
Primary outcome timeframe
baseline and at the end of 12 months post index date
Results posted on
2019-09-17
Participant Flow
Potentially eligible patients for inclusion in this study were those who: (1) were ≥18 years of age, (2) had filled a prescription for 1 or more oral hypoglycemic agents within the prior 12 months, and (3) had evidence of poor glycemic control (A1C ≥8%) within the previous 6 months.
Patients were excluded if, prior to identification, they had fewer than 3 months of continuous enrolment in the health plan, had recently filled insulin or had no available telephone contact information.
Participant milestones
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Overall Study
STARTED
|
700
|
700
|
|
Overall Study
COMPLETED
|
678
|
684
|
|
Overall Study
NOT COMPLETED
|
22
|
16
|
Reasons for withdrawal
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Overall Study
Lost insurance eligibility
|
22
|
16
|
Baseline Characteristics
Full Analysis Set
Baseline characteristics by cohort
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
n=678 Participants
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
n=684 Participants
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
Total
n=1362 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 Years
STANDARD_DEVIATION 8.1 • n=5 Participants • Full Analysis Set
|
54.6 Years
STANDARD_DEVIATION 8.4 • n=7 Participants • Full Analysis Set
|
54.6 Years
STANDARD_DEVIATION 8.3 • n=5 Participants • Full Analysis Set
|
|
Sex: Female, Male
Female
|
236 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
509 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
442 Participants
n=5 Participants
|
411 Participants
n=7 Participants
|
853 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
678 Participants
n=5 Participants
|
684 Participants
n=7 Participants
|
1362 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and at the end of 12 months post index datePopulation: Full Analysis Set
Pre- to post-intervention change in mean HbA1c levels
Outcome measures
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
n=678 Participants
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
n=684 Participants
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Glycosylated Hemoglobin (HbA1c):
|
-0.75 Percentage of HbA1c
Standard Deviation 1.96
|
-0.79 Percentage of HbA1c
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: during follow-up period of 12 months post index datePopulation: Full Analysis Set
Mean Adherence (PDC) in each study arm in the follow-up period
Outcome measures
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
n=678 Participants
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
n=684 Participants
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Medication Adherence (PDC Measure)
|
67.5 Percentage of Days
Standard Deviation 31.6
|
66.2 Percentage of Days
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: during follow-up period of 12 months post index datePopulation: Full Analysis Set
Percentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC ≥0.80) in the follow-up period
Outcome measures
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
n=678 Participants
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
n=684 Participants
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Percentage (Proportion x 100) of Patients Achieving Optimal Adherence
|
46.2 Percentage of Participants
|
45.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: baseline and at the end of 12 months post index datePopulation: Full Analysis Set
Percentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period
Outcome measures
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
n=678 Participants
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
n=684 Participants
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Patients Achieving HbA1c
|
34.8 Percentage of Participants
|
38.0 Percentage of Participants
|
Adverse Events
Shared Decision Making/Brief Negotiated Interviewing
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
n=678 participants at risk
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
n=684 participants at risk
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.15%
1/678 • Number of events 1 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
0.00%
0/684 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
|
Gastrointestinal disorders
Diarrhea
|
0.15%
1/678 • Number of events 1 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
0.00%
0/684 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
|
General disorders
Fatigue
|
0.15%
1/678 • Number of events 1 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
0.00%
0/684 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.15%
1/678 • Number of events 3 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
0.00%
0/684 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.15%
1/678 • Number of events 1 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
0.00%
0/684 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
Other adverse events
| Measure |
Shared Decision Making/Brief Negotiated Interviewing
n=678 participants at risk
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
|
Control Arm
n=684 participants at risk
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.15%
1/678 • Number of events 1 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
0.00%
0/684 • 12 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place