Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02891382 |
| Other study ID # |
MR/M007405/1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2016 |
| Est. completion date |
February 2017 |
Study information
| Verified date |
January 2022 |
| Source |
Universidad Peruana Cayetano Heredia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This feasibility study aims to compare the implementation process of three different
interventions that use economic incentives to promote lifestyle behavioral changes in
patients with type 2 diabetes mellitus, and to identify barriers and facilitators linked to
the process of implementing each of the interventions. The interventions are based on
economic incentives directed to the patient (individual incentives) or a team comprised by
the patient and a partner (mixed incentives).
Design: Three-month randomized control feasibility study to test the feasibility of
implementing three types of intervention with economic incentives in patients with diabetes
mellitus.
Setting: Diabetes outpatient clinics from a public hospital in Peru.
Description:
Economic incentives have been used to promote changes in habits such as smoking and weight
loss. However, no studies have been done to determine the impact of this strategy on the
management of type 2 diabetes mellitus (T2DM). Additionally, previous studies do not describe
ways to determine the amount of an economic incentive to promote behavioral changes, e.g
adherence to treatment, increased physical activity and adherence to a healthy diet. There
are also questions regarding the frequency of incentives, the type of incentive (cash or
other prizes), and the preferred payment method that this study will allow us to explore.
Furthermore, we want to test whether a "team work approach" (mixed incentives) vs. an
"individual approach" (individual incentives) can also play a role in introducing behavioral
changes.
The goal of the study is to learn about the implementation process of three different
interventions that use economic incentives to promote behavioral changes in patients with
T2DM, and identify main barriers and facilitators tied to the implementation process of each
intervention.
This feasibility study will provide key insights to inform a future larger study;
specifically, we will
- Learn about the experience of participants with T2DM with economic incentives.
- Learn about the experience of the companion/team support partners of the participants
with T2DM.
- Evaluate the patient's receptiveness to and comprehension of the educational materials
used to promote behavioral changes.
- Evaluate the patient and the companion/team support partner's receptiveness towards the
received economic incentive as a tool for promoting behavioral changes.
- Explore the companion/team support partner's activities that are most effective in
helping with T2DM management of patients.
- Explore whether patients with T2DM are able to keep a daily record of their efforts to
manage their diabetes.
- Evaluate the feasibility of packaging and implementing a future clinical trial that
evaluates the impact of the use of economic incentives and teamwork in people with T2DM.
From a clinical perspective, we will evaluate the feasibility of reaching the proposed
clinical goals in terms of weight loss and HbA1c levels after the intervention period.
Interventions
Diabetes education (all arms). In the introductory meeting, a diabetes educator will explain
to the participants all the procedures, including details of the number of sessions, and the
participant's received a manual with information about diabetes management with a tailored
weight loss plan. Each participant will be offered up to seven follow- up sessions with the
diabetes educator, every two weeks, plus a final session, thus totaling up to 9 one-to-one
interactions during the trial, provided that the participant attended all of their meetings.
Participants will also be provided with a logbook to register their efforts regarding
introducing changes in diet and physical activity. The information from this logbook will
provide the starting point for conversations with the diabetes educator during the follow-up
sessions, every two weeks.
Goal setting (all arms). To determine eligibility for a cash reward, three goals were
pre-specified: (1) Weight loss, 80 PEN if the participant loses one kilogram over a period of
two weeks, (2) HbA1c level, 200 PEN if the participant achieves, at the end of the study, a
decrease in 1% compared to their baseline level, and (3) HbA1c level and control, 400 PEN if
the participant achieves, at the end of the study, a decrease ≥1% of A1c or reaches levels of
A1c ≤6.5% compared to their baseline level. At the end of the study, targets for weight loss
and HbA1c were evaluated independently, i.e. participants could receive more than one reward
provided that each independent target was achieved.
Companion/team support (Arm 2 and Arm 3). A companion/team support for each participant also
receives information about diabetes care in the initial session and a brochure to guide and
support the treatment process of the participant. The activities of the companion/team
support member will be recorded, and they will be offered to join the follow- up sessions
with the patient, every two weeks, but these will not be compulsory.
Cash rewards. Two types of rewards will be considered. (1) Individual rewards (Arm 1 and Arm
2), the reward will be provided to the participant. If the participant were to have a
companion/team support partner, the cash reward was given to the participant and no rules
about sharing the reward (or not) with their companion/team support are established. (2)
Shared rewards (Arm 3), i.e. the participant and their companion/team support will receive
50% of the cash reward each.
