Trial Outcomes & Findings for Feasibility Study on the Impact of Economic Incentives to Improve the Management of Type 2 Diabetes Mellitus (NCT NCT02891382)
NCT ID: NCT02891382
Last Updated: 2024-02-02
Results Overview
HbA1c change at 3 months from baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
Individual Incentives - Arm 1
This arm receives diabetes education + goal setting + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2 Patients
This arm receives diabetes education + goal setting + companion support + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to help him/her in achieving goals.
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2 Companions
The companion support help the partner to achieve goals.
The cash reward is given to the patient with diabetes and not to the companion.
|
Mixed Incentives (Cooperation) - Arm 3 Patients
This arm receives diabetes education + goal setting + companion support + shared rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to help him/her in achieving goals.
Shared Reward: Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
Mixed Incentives (Cooperation) - Arm 3 Companions
The companion support help the partner to achieve goals.
Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
15
|
14
|
13
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
5
|
3
|
4
|
Reasons for withdrawal
| Measure |
Individual Incentives - Arm 1
This arm receives diabetes education + goal setting + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2 Patients
This arm receives diabetes education + goal setting + companion support + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to help him/her in achieving goals.
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2 Companions
The companion support help the partner to achieve goals.
The cash reward is given to the patient with diabetes and not to the companion.
|
Mixed Incentives (Cooperation) - Arm 3 Patients
This arm receives diabetes education + goal setting + companion support + shared rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to help him/her in achieving goals.
Shared Reward: Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
Mixed Incentives (Cooperation) - Arm 3 Companions
The companion support help the partner to achieve goals.
Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
5
|
3
|
4
|
Baseline Characteristics
Glycated hemoglobin was not analyzed in the companions
Baseline characteristics by cohort
| Measure |
Individual Incentives - Arm 1
n=18 Participants
This arm receives diabetes education + goal setting + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2 Patients
n=18 Participants
This arm receives diabetes education + goal setting + companion support + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to support achieving goals.
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2 Companions
n=18 Participants
The companion support help the partner to achieve goals.
The cash reward is given to the patient with diabetes and not to the companion.
|
Mixed Incentives (Cooperation) - Arm 3 Patient
n=18 Participants
This arm receives diabetes education + goal setting + companion support + shared rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to support achieving goals.
Shared Reward: Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
Mixed Incentives (Cooperation) - Arm 3 Companion
n=18 Participants
The companion support help the partner to achieve goals.
Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=90 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=18 Participants
|
16 Participants
n=18 Participants
|
15 Participants
n=18 Participants
|
16 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
81 Participants
n=90 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
9 Participants
n=90 Participants
|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 9.8 • n=18 Participants
|
55.5 years
STANDARD_DEVIATION 9.8 • n=18 Participants
|
49.8 years
STANDARD_DEVIATION 15.9 • n=18 Participants
|
54.2 years
STANDARD_DEVIATION 7.6 • n=18 Participants
|
39.7 years
STANDARD_DEVIATION 16.6 • n=18 Participants
|
54.4 years
STANDARD_DEVIATION 9.0 • n=90 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
58 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
32 Participants
n=90 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
90 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=90 Participants
|
|
Region of Enrollment
Peru
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
90 Participants
n=90 Participants
|
|
Glycated Hemoglobin
|
8.5 "Percentage of glycated hemoglobin"
STANDARD_DEVIATION 2.2 • n=18 Participants • Glycated hemoglobin was not analyzed in the companions
|
7.9 "Percentage of glycated hemoglobin"
STANDARD_DEVIATION 3.1 • n=18 Participants • Glycated hemoglobin was not analyzed in the companions
|
—
|
8.2 "Percentage of glycated hemoglobin"
STANDARD_DEVIATION 2.1 • n=18 Participants • Glycated hemoglobin was not analyzed in the companions
|
—
|
8.2 "Percentage of glycated hemoglobin"
STANDARD_DEVIATION 2.5 • n=54 Participants • Glycated hemoglobin was not analyzed in the companions
|
|
Weight
|
76.9 Kg
STANDARD_DEVIATION 10.7 • n=18 Participants • Clinical data was not measure in the companions
|
84.5 Kg
STANDARD_DEVIATION 17.4 • n=18 Participants • Clinical data was not measure in the companions
|
—
|
85.1 Kg
STANDARD_DEVIATION 22.3 • n=18 Participants • Clinical data was not measure in the companions
|
—
|
82.1 Kg
STANDARD_DEVIATION 17.5 • n=54 Participants • Clinical data was not measure in the companions
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Some participants had data about weight but not about glycated hemoglobin and for that reason the number of participants in this table are different from the table that show the results of weight.
HbA1c change at 3 months from baseline
Outcome measures
| Measure |
Individual Incentives - Arm 1
n=13 Participants
This arm receives diabetes education + goal setting + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2
n=13 Participants
This arm receives diabetes education + goal setting + companion support + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to support achieving goals.
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Cooperation) - Arm 3
n=14 Participants
This arm receives diabetes education + goal setting + companion support + shared rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to support achieving goals.
Shared Reward: Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
|---|---|---|---|
|
Change in Glycated Hemoglobin
|
1.4 "Percentage of glycated hemoglobin"
Standard Deviation 1.4
|
0.9 "Percentage of glycated hemoglobin"
Standard Deviation 1.2
|
1.1 "Percentage of glycated hemoglobin"
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Some participants had data about weight but not about glycated hemoglobin and for that reason the number of participants in this table are different from the table that show the results of glycated hemoglobin.
Weight change at 3 months from baseline
Outcome measures
| Measure |
Individual Incentives - Arm 1
n=15 Participants
This arm receives diabetes education + goal setting + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Altruism) - Arm 2
n=14 Participants
This arm receives diabetes education + goal setting + companion support + individual rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to support achieving goals.
Individual Reward: The cash reward is given to the patient with diabetes.
|
Mixed Incentives (Cooperation) - Arm 3
n=15 Participants
This arm receives diabetes education + goal setting + companion support + shared rewards
Diabetes education: Participants interact with a diabetes educator (DE), every two weeks.
Goal setting: Goals for weight loss and change in levels of HbA1c
Companion Support: Patient has a companion/team support partner to support achieving goals.
Shared Reward: Patients with diabetes and their companion support will each receive 50% of the cash reward.
|
|---|---|---|---|
|
Change in Weight
|
2.9 Kg
Standard Deviation 2.2
|
0.4 Kg
Standard Deviation 2.5
|
0.4 Kg
Standard Deviation 3.0
|
Adverse Events
Individual Incentives - Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mixed Incentives (Altruism) - Arm 2 Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mixed Incentives (Cooperation) - Arm 3 Patients
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
Dr. J Jaime Miranda
Universidad Peruana Cayetano Heredia
Phone: +511 241 69 78
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place