REDEEM trial: The effect of individual and mixed REwards in DiabEtEs Management, a randomised controlled trial

Lead Research Organisation: Peruvian University Cayetano Heredia
Department Name: Research

Abstract

Studies in developed countries have demonstrated benefits to preventive care (diet modifications, exercise) among patients with diabetes. Despite this knowledge, patients often don't manage their diabetes properly. In a study that we conducted in Lima, 71% of subjects with diabetes were aware of their disease, 40% were receiving treatment, and only 7% had achieved therapeutic goals. In Latin America, diabetes has a great impact on the health system due to high costs of disease control (US$10.7 billion) and indirect costs (US$54.5 billion) related to loss of productivity, disability, and premature death.

Payment for achieving therapeutic goals, or "rewards," have been tested as a way to improve health. Several studies have shown the promise of this approach in encouraging and maintaining weight loss, which is an important way to control diabetes. One study found that paying people to lose weight led to significantly greater weight loss. In another study in which the payments were linked to the success of multiple members of a group achieving their weight loss goals, the participants not only lost more weight, but also maintained the weight loss. These results are intriguing, and suggest that the study of rewards in self-management of diabetes requires further research.

The approach of paying people to achieve health-related goals has also worked in developing countries. For example, Juntos is a program in Peru that pays pregnant women and mothers to utilize certain health services. On study found that Juntos increased the probability that children in households met their weight-height goals. In addition, families that were part of Juntos were more likely to seek professional health assistance in case of any disease, and the pregnant women were more likely to have their delivery attended by a skilled professional. This type of program takes advantage of the strong family structures in Latin America, and brings an element of group responsibility to the improvement of health. The individual responsible for fulfilling the requirements is not only encouraged to be responsible because of an individual reward, but to improve the situation of the family. This highlights the potential to use responsibility to others to design more effective policies.

In this project, our goal is to determine the effectiveness of two different economic reward programs in promoting preventive behaviors and improving the health of individuals with Type II diabetes in Peru. In addition to rewarding patients for their improved health outcomes, we will go one step further and evaluate a cash incentive for a family or friend supporter, an approach we believe has great potential and may be more effective. In our study, we will enroll diabetes patients and randomly assign them to one of three groups. In one group, patients will receive cash rewards if they achieve certain goals related to management of their diabetes. In a second group, patients and a family or friend supporter will both receive a cash reward if the patient achieves their diabetes management goals. This will allow us to test whether or not the element of responsibility to others improves the ability of the patient to achieve their goals. Finally, a third group will not receive any cash reward. This is the "control" group to which the other groups will be compared to measure success of our approaches.

We expect that after nine months of rewards, patients will effectively improve the preventive behaviors. Six months later, we will also assess if these improvements have been maintained without the cash reward. If our study is successful, it could be a way to encourage people with diabetes to better manage their disease. While there are costs associated with this approach, it could save money in the long run by reducing the complications of diabetes that occur when people don't manage their disease.

Technical Summary

There is strong evidence of benefits of preventive care among patients with diabetes, but adherence to guidelines worldwide is quite low and this constitutes a major problem across healthcare systems. Cash rewards have been tested in adherence to treatment for substance abusers, and to promote weight loss and smoking cessation. Less is known about the effect on behaviour of pairing individual cash with group cash rewards or cash rewards to a family member or friend who provides support in the process.

This study will explore the ability of rewards to change the behaviour of individuals with type II diabetes in a randomised controlled trial. Two different nine-month reward strategies will be tested against usual care (control group). One arm will receive individual-only cash rewards. A separate arm will receive mixed rewards, which consist of individual cash reward plus a cash reward to a supportive individual chosen by the study participant. The primary outcome will be metabolic control rates as per HbA1c criteria.

Research Question 1 will compare the effect of each of the intervention arms against the control group on the primary study outcomes at nine months.

Research Question 2 will allow a comparison between the two reward interventions in terms of behavioural-related goals.

Research Question 3 will explore, within each of the intervention groups, if the intrinsic motivation sustains six months after the removal of the reward.

Fourth, throughout the study qualitative data will be collected. If the trial is successful, e.g. if Research Questions 1 and 2 do show an effect, we will be well positioned to gain an understanding about the pathways on which the intervention operates to achieve the observed differences. In addition, we will complete a cost-effectiveness analysis to demonstrate the feasibility of the proposed approach, if our intervention shows a benefit.

Planned Impact

One of the main beneficiaries of this research are diabetes patients, as our intervention could greatly improve their health outcomes. Clinical trials in developed countries and population-based studies have indicated that there are major benefits to be achieved by preventive care among patients with diabetes. However, despite the medical consensus on the effectiveness of preventive measures, achievement of control targets by patients worldwide is quite low. In this application, we aim to explore the role of rewards to change the preventive behaviour of individuals with Type II diabetes in a randomised controlled trial in Peru. If we are successful and our intervention is implemented, it could have a significant impact on the health outcomes of patients with diabetes. This will benefit them personally, and will also benefit their families by extension, both emotionally and financially.

In addition, policymakers can benefit from this research, as it can help them to design improved interventions for the management of diabetes patients. For example, Peru's Ministry of Inclusion and Social Development (MIDIS) already recognizes the value of economic rewards and have implemented them in other health-related areas. They will be very interested in the results of our study, and could support and benefit from its implementation. Our intervention could also benefit the financial state of the health care system by reducing the costs of morbidity and mortality associated with diabetes. For example, ESSALUD, the social health insurance in Peru, could benefit from our intervention, as it could lead to reduced morbidity and mortality in patients with diabetes, leading to a reduction in health care costs. We have included letters of support from both MIDIS and ESSALUD, demonstrating their interest and potential involvement in the future of our intervention.

Finally, academic researchers will also benefit from our research. Mixed rewards have not been explored in a health care context. These types of rewards may improve performance when the agent has low knowledge about their ability and cost of their action, which is of particular relevance in the case of diabetes management. Peer pressure may elicit higher individual effort than pure cash rewards, and sentiments of trust and group belonging may create additional pressure for individuals to perform better in mixed reward than in pure cash rewards. If our results are promising, they could lead to studies of this type of intervention in other areas of health care.

Publications

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Benziger CP (2018) Low prevalence of ideal cardiovascular health in Peru. in Heart (British Cardiac Society)

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Francis ER (2016) Establishing a higher priority for chronic kidney disease in Peru. in The Lancet. Global health

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Gold SM (2020) Comorbid depression in medical diseases. in Nature reviews. Disease primers

 
Description This study was designed to evaluate the feasibility of implementing individual and mixed cash rewards on HbA1c and weight loss among patients with type 2 diabetes mellitus. After completion of the 3-month intervention, notable reductions were observed in HbA1c, weight and BMI, and also in some of the intermediate and self-reported outcomes. Subgroup analysis confirm reductions in weight and BMI among those who complete a higher number of appointments and more clearly among those who achieve early success, i.e. those who were eligible to receive a cash reward during their first two appointments.

Contrasting with the effect of oral antidiabetic drugs, which lowers HbA1c in the order of 0.5%-1.25%, our results, derived from a complex intervention relying on diabetes education with tailored goal-setting with or without group (partner) support, showed reductions in HbA1c of similar magnitude to those achieved with pharmacological treatment.
Exploitation Route This study was intended to generate hypotheses, and the rationale for using the term feasibility in this work was informed by a combination of issues related to the fieldwork, to packaging and deploying the intervention, and the experience of the support partner. In terms of fieldwork, we document the ability to approach, identify eligible individuals, as well as to recruit, enroll, and follow-up sufficient number of patients and partners. Key aspects of the intervention include the capacity to deliver the intervention, an intense intervention with tailoring features, and to have a separate team to measure outcomes, expressed in the results reported. Acceptability of the intervention and challenges of the implementation were also captured in the post-study interviews reporting the experience of the partner support. The accomplishment of recruitment and conduction of this study, together with the uptake of the intervention by the study participants as well as the lessons from the experience of the partner support, demonstrate the feasibility of conducting larger effectiveness studies using individual incentives and mixed incentives involving carers for supporting diabetes management.
Sectors Agriculture, Food and Drink,Communities and Social Services/Policy,Creative Economy,Education,Electronics,Environment,Financial Services, and Management Consultancy,Healthcare,Leisure Activities, including Sports, Recreation and Tourism,Government, Democracy and Justice,Pharmaceuticals and Medical Biotechnology,Transport

 
Description - with the clinical teams that manage diabetes, who are more aware of complex interventions and the challenges, at the individual level, of ensuring compliance with the treatment for diabetes. - with policymakers, including former Ministers of Health and former Minister of Social Inclusion, who were invited to be part of an advisory board as part of a proposal for a larger study. The proposal was not funded, but it was well received by the advisory board who supported the idea.
First Year Of Impact 2018
Sector Agriculture, Food and Drink,Communities and Social Services/Policy,Digital/Communication/Information Technologies (including Software),Education,Financial Services, and Management Consultancy,Healthcare,Leisure Activities, including Sports, Recreation and Tourism,Pharmaceuticals and Medical Biotechnology,Transport
Impact Types Societal,Economic,Policy & public services

 
Description Diabetes Education Manual for patients
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Addressing the double burden of disease: improving health system for Noncommunicable and Neglected Tropical Diseases
Amount SFr. 3,350,000 (CHF)
Funding ID 40P740-160366 
Organisation Swiss National Science Foundation 
Sector Public
Country Switzerland
Start 02/2016 
End 02/2022
 
Description Chronic Kidney Disease of unknown cause (CKDu) in disadvantaged communities in low-and-middle income countries (LMICs)
Amount £0 (GBP)
Funding ID MR/P02386X/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 05/2017 
End 05/2019
 
Description Household air pollution and health: A multi-country LPG intervention trial
Amount $6,176,184 (USD)
Funding ID 1UM1HL134590 
Organisation National Institutes of Health (NIH) 
Sector Public
Country United States
Start 09/2016 
End 09/2021
 
Description Implementation of COPD Case Finding and Self-Management Action Plans in Low and Middle Income Countries
Amount £1,122,116 (GBP)
Funding ID MR/P008984/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 01/2017 
End 12/2019
 
Description Scaling-up and evaluating salt/sodium reduction policies and programs in Latin American countries
Amount $1,200,000 (CAD)
Funding ID 108167 
Organisation International Development Research Centre 
Sector Public
Country Canada
Start 09/2016 
End 09/2019
 
Description UNC Chapel Hill Practicum
Amount $5,000 (USD)
Organisation UNC Gillings School of Global Public Health 
Sector Academic/University
Country United States
Start 05/2016 
End 07/2016
 
Title Economic incentive determination 
Description The rationale behind the amount of economic incentives in behavioral interventions is rarely described. We propose a set of inputs to determine the amount of the economic incentive we gave participants: miinimum wage, amount given in cash transfer programs, the amount people are willing to pay for loosing weight and the amount of money peoplw are willing to accept as payment for loosing weight. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact This method enabled us to determine an appropriate amount to promote behavioral change in the study participants. 
 
Title Database REDEEM trial 
Description The database of REDEEM trial includes all the variables collected during the study. We have information from 54 participants at baseline and their respectives companions. Baseline data of participants is related sociodemographic characteristics, diabetes care and lifestyle. Also we have information of the follow up visits that include information of weight, lifestyle and support of the companion. 
Type Of Material Database/Collection of data 
Year Produced 2019 
Provided To Others? Yes  
Impact The database was used by researchers to analyse and publish the results of the REDEEM trials. 
URL https://figshare.com/articles/REDEEM_Study_Feasibility_pilot_study/7180802
 
Description COHESION Project 
Organisation Geneva University Hospitals
Country Switzerland 
Sector Hospitals 
PI Contribution COHESION is a new project, recently awarded by the Swiss National Foundation, aiming at pursuing a clear understanding of barriers and enablers for diagnosis, management and care of Non-Communicable Diseases and Neglected Tropical Diseases in Nepal, Mozambique, and Peru. We have participated since the design of the proposal and built upon a previous relationship with Dr David Beran to expand our common interests in NCDs in LMIC.
Collaborator Contribution Peru will be one of the study sites for this collaboration.
Impact Funding awarded.
Start Year 2015
 
Description Collaboration with Hospital Arzobispo Loayza Endocrinology Service 
Organisation Hospital Nacional Arzobispo Loayza
Country Peru 
Sector Hospitals 
PI Contribution We have established a good working relationship with de endocrinology service at the public hospital Arzobispo Loayza. Through our meetings with the doctors we have been able to improve our research protocol, have access to patients and build a partnership for future research.
Collaborator Contribution - Input to the protocol regarding inclusion criteria and the educational material we designed for the project participants.
Impact We are preparing at least two manuscripts based on the study results where two doctors of the endocrinology service will be contributing with.
Start Year 2016
 
Description JHU 
Organisation Johns Hopkins University
Country United States 
Sector Academic/University 
PI Contribution We have established the CRONICAS Centre of Excellence in Chronic Diseases at Universidad Peruana Cayetano Heredia
Collaborator Contribution Joint faculty from JHU and UPCH got together to produce a strong application that secured one of the NHLBI's Centre of Excellence awards.
Impact - Multiple papers - Ancillary studies - Capacity building - Further grants secured
Start Year 2008
 
Description LSHTM NCDs 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Department Faculty of Epidemiology and Population Health
Country United Kingdom 
Sector Academic/University 
PI Contribution I completed my Masters and PhD in Epidemiology and LSHTM, funded by Wellcome Trust. Ever since I have maintained the links and collaborations with this institution and various colleagues.
Collaborator Contribution - Funding opportunities - Capacity Building, training
Impact Various grants and papers. My main collaborator at LSHTM is Prof Smeeth, and together we have, to date 28 joint publications. http://www.ncbi.nlm.nih.gov/pubmed/?term=Miranda+JJ%5BAuthor%5D+AND+Smeeth%5BAuthor%5D
 
Description MRC Review Panel 
Organisation Medical Research Council (MRC)
Country United Kingdom 
Sector Public 
PI Contribution I have served in the Review Panels of the MRC Adolescents Health 2016
Collaborator Contribution Invitation to a selected group of people to review grant applications at a very highly competitive level.
Impact Learnt about Grant funding and Panel decisions.
Start Year 2016
 
Title Economic Incentives to Improve the Management of Type 2 Diabetes Mellitus 
Description This pilot 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 (T2DM), 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 pilot study to test the feasibility of implementing three types of intervention with economic incentives. Setting: Diabetes outpatient clinics from a public hospital in Peru. Population: Subjects are eligible if they (1) have a diagnosis of type 2 diabetes mellitus, (2) are between 18 - 70 years of age, (3) have a body mass index between 25 - 39.9 kg/m2, (4) do not have blindness or amputations or foot ulcers or are on dialysis, and (6) have the ability to provide informed consent. To be eligible as a "partner" for the participant with diabetes, the partner has to (1) be between 18 and 70 years of age, (2) not have a physical or mental impairment that does not allow him to help the participant to lose weight, (4) be available and committed to supporting the participant in achieving their weight loss goals, and (5) be able to provide informed consent. Outcomes: Feasibility of conducting a three-arm incentives-based pilot study. Secondary outcomes: Weight loss, and change in glycated hemoglobin after 3 month. We have completed the delivery of the intervention, we are analysing the data and doing a follow-up after 7 months of completion, 
Type Management of Diseases and Conditions
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2017
Development Status Closed
Clinical Trial? Yes
Impact A total of 54 eligible subjects were randomized, 18 in each study arm. Mean age was 54.5 (SD: 8.9) years and 66% were females. We did not find differences between study groups in the clinical, sociodemographic, anthropometric measurements (weight), and glycated hemoglobin measurements. A total of 10 (18.5%) individuals were lost to follow-up. The individual incentive reduced weight significantly compared to the mixed incentives arms. In addition, a greater effect on A1c reduction was seen in the individual incentive and mixed incentives 2 (i.e. the arm in which the incentive was split between patient and partner). A clinical trial with patient-important outcomes is needed to implement and scale up this intervention. 
URL https://clinicaltrials.gov/show/NCT02891382
 
Description Monthly visits to Endocrinology Service, Hospital Nacional Arzobispo Loayza 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Monthly visits with 4-6 staff from the endocrinology service, plus their physicians in training (residents), nurses and technicians to optimize collaborations. This has provided support to existing projects plus initiation of new projects of common interests. Before they used to collect data for clinical trials (pharma-funded), now they are engaged in pursuing their own research questions.
Year(s) Of Engagement Activity 2016,2017