Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03626909 |
| Other study ID # |
2017-0596 |
| Secondary ID |
A534100SMPH\EMER |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2018 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
December 2020 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this study, the investigators will be using a smartphone application that the
investigators developed to guide community health workers through the clinical assessment of
patients with diabetes including collection of demographic data and past medical history,
assessment of medication history, adherence, and adverse effects, measurement of glycemic
control, screening for complications, medication administration and titration, and patient
counseling.
Description:
The burden of chronic adult diseases is surging worldwide, particularly type 2 diabetes, the
prevalence of which is expected to double by 2030. The diabetes epidemic will primarily
impact developing countries, with 80% of adult cases occurring in low- and middle-income
countries (LMICs). Because many LMICs currently face a shortage of health professionals, the
increasing burden of noncommunicable diseases, like type 2 diabetes, will tax already
strained health systems. Furthermore, because many LMIC health care systems were developed to
target acute illnesses and communicable disease, they are ill-prepared to treat and manage
chronic adult disease. The divergence between the growing burden of chronic disease and the
development of the health systems necessary to treat these diseases indicate the potential
for a grave health, economic, and human crisis in the following decades. The WHO has
consequently demanded that physicians designs systems providing "Innovative Care for Chronic
Conditions" to meet this challenge4.
However, existing tools may provide a foundation for solutions to this growing crisis.
Community Health Workers (CHWs, as known as health promoters) have become central to global
health strategies since the Alma Ata Declaration of 1978, particularly in regions with
physician shortages. In recent years, CHWs have had notable success in targeting childhood
disease, particularly malnutrition and diarrhea, and offer a growing variety of primary care
services. The success of these programs in providing consistent, sustainable care at the
local level implies that longitudinal treatment for chronic adult diseases could be provided
through parallel structures. While the treatment of chronic disease has become increasingly
complex, the proliferation of smartphone and tablets across the globe have raised hopes that
mobile health technology (mHealth) platforms can provide CHWs with algorithmic guidance on
assessing and treating a broader set of diseases. The potential use of mHealth is a
burgeoning field of global health research. The combination of CHWs and mHealth guidance may
provide a solution to the rise of chronic disease in regions with physician shortages and
weak health systems.
While many mHealth applications have been developed for Diabetes (over 1,000 are commercially
available), only a small percentage (7.6%) are targeted to providers - and even fewer to
providers in LMICs. Instead, these tools most commonly serve as tools for patient
self-management, patient education, and medication adherence. A handful of programs have
utilized smartphone technology to connect remote patients to health care workers in LMICs as
well as to provide clinical guidance to providers, but such programs have been minimal and
publications have been process oriented. In addition to improving diabetes care in the target
population, the project also seeks to add to the evidence for this approach by designing an
application-based algorithm that can assist CHWs in providing long-term diabetes care,
titrating first- and second-line oral diabetes medications, and identifying dangerous
diabetes complications in a setting of a lower middle-income country with a low physician
density.
To test this delivery approach,the investigators focused on developing a diabetes treatment
program in San Lucas Tolimán, Guatemala. This program seeks to provide treatment to diabetics
living in the group of 19 rural villages with a combined population of 17,000, which surround
San Lucas. San Lucas is an ideal community for studying these topics because it is facing a
heavy burden of untreated Type II Diabetes, has medical personnel with mHealth experience,
and has a well-developed CHW program. This CHW program is sponsored by the San Lucas Mission
(SLM), an NGO providing health services in the area and a University of Wisconsin and
Stanford University partner organization. Local health workers describe the increase in Type
II Diabetes as an epidemic and there are few systems in place to provide community members
with diabetes screening or effective and consistent treatment. Startling regional data on
Type II Diabetes supports this concern: in Guatemala, the prevalence of diabetes has been
estimated at 9.1-9.4%, with over 40% of cases undiagnosed22-24. The prevalence of diabetes
has doubled over the past 30 years25. Fortunately, San Lucas has already developed a strong
CHW program, including a tablet-based mHealth application that targets early childhood
malnutrition, through a collaboration between the San Lucas Mission and Stanford School of
Medicine. This application has enhanced the successful malnutrition program, allowing CHWs to
more easily identify and manage malnutrition and decreasing training requirements for CHWs26.
Utilizing the existence of the CHW program infrastructure and the established mHealth
platform, the project seeks to develop and implement a CHW-led diabetes treatment program in
San Lucas that is assisted by a smartphone application.
In order to inform the development of the smartphone application and program protocols, the
investigators conducted a community needs assessment during the summer of 2016. Clinical data
was used to provide a baseline estimate of diabetes prevalence and distribution in the
communities as well as demographic risk factors. Interviews were conducted with local
physicians, CHWs, and managers of the CHW system to understand current methods of diabetes
treatment and define the limitations of these systems. Out of the 119 patients currently
diagnosed with diabetes in the rural communities, 31 were interviewed to illuminate how the
disease is currently diagnosed and treated, the effect the disease has on patient lifestyles,
and patients' desired attributes for a diabetes treatment program. Finally,the investigators
visited local diabetes clinics to determine the current state of diabetes treatment, the
availability of medications and resources, and the level of care provided to patients.
Key findings of the community needs assessment were as follows:
1. Patients with diabetes in the rural communities have poor access to quality diabetes
care. Only 58% of patients are taking medication on a regular basis and only 13% have
achieved good glycemic control
2. Outreach clinics run by CHWs are disorganized, undersupplied, sporadic, and ineffective
3. CHWs lack the experience and training to effectively titrate oral diabetes medications,
assess for possible complications, and provide health education for patients
4. Patients lack basic diabetes knowledge, particularly regarding self-management
Utilizing the knowledge gained with this needs assessment, established treatment guidelines
for diabetes, and the expertise of SLM medical director Dr. Rafael Tun and the coordinators
the SLM CHW program, the investigators developed protocols for the diabetes program,
including a smartphone application to allow for algorithmic management. This process was
iterative and collaborative and involved local partners at every step.
The investigators then trained a group of 10 CHWs, including 5 CHW coordinators (who have
more clinical experience and take on a supervisory and training role for less-experienced
CHWs) in the basics of diabetes management, program protocols, and the use of the smartphone
application the investigators had developed. With close physician supervision, the
investigators have beta-tested the use of the application with a small group of patients.
Based on this experience, the investigators have further refined the application and program
protocols. The investigators now endeavor to implement this program on a wide scale in the
San Lucas area to both improve access to care for patients with diabetes and to establish the
efficacy, feasibility, and safety of CHW-led, smartphone application-guided diabetes
treatment.
An overview of study activities is as follows:
- The investigators will train additional CHWs in basic diabetes care, use of
point-of-care (POC) testing technology, and use of the smartphone application that will
guide their management of patients with diabetes.
- CHWs will recruit patients with diabetes in the rural villages outside of San Lucas to
participate in the program.
- At the enrollment visit, CHWs will use the smartphone application to screen patients for
appropriate inclusion in the program, establish glycemic targets, assess current
glycemic control with hemoglobin A1c and blood glucose, measure height, weight, blood
pressure, and waist circumference, assess for the presence of diabetes complications
(diabetic ulcers, angina, diabetic eye disease), administer oral medications (metformin
and/or glyburide, known locally by its alternate name glibenclamide) based on a
medication dosing algorithm, and provide diabetes self-management education.
- CHWs will meet with patients on a monthly basis to assess medication adherence and for
adverse effects, glycemic control (with blood glucose), screen for diabetic
complications, refill medications with titration as needed (if experiencing medication
adverse effects or blood glucose is significantly above or below treatment goals), and
provide further diabetes education. Again, these activities will be guided by the
smartphone application. Every 3 months, the monthly visit will also include A1c
measurement for a more definitive measurement of diabetes control and to allow for
titration of medications. Patients who are identified as having complications or who are
not meeting treatment goals despite maximal dosing of metformin and glibenclamide
allowed by the algorithm will be referred to SLM medical director Dr. Rafael Tun for
definitive management.
- After all visits, including enrollment and monthly visits, Dr. Tun, in addition to the
study investigators, will review data for all patients seen, including treatment
recommendations made by the application and carried out by the CHWs, and make any
changes to the treatment plan as needed based on his clinical judgement.
- Mean hemoglobin A1c and proportion of patients meeting treatment goals (primary
endpoints) will be assessed at 6 months and compared to baseline, in addition to a
number of secondary endpoints and safety measures as described in the relevant sections
of this protocol. If possible, patients will also be followed out to 12 months with
reassessment of primary and secondary endpoints.
- SLM hopes to continue this rural diabetes treatment program indefinitely, with the
results of this study informing a quality improvement process to ensure the provision of
high quality care.
The investigators believe that the novel aspect of this intervention, the use of a smartphone
application to guide treatment decisions, improves on previous protocol-driven approaches in
several ways. The use of a mobile computer-based algorithm as opposed to a paper algorithm
allows for greater complexity and the incorporation of additional factors relevant to patient
safety, such as the patient's current dose of medication, medication adherence, and
medication side effects, in order to provide more specific recommendations. In this way, it
decreases the cognitive burden placed on CHWs and the potential for human error. Rather than
having to follow a complicated paper flowchart, CHWs will input information into the
smartphone application, which will process the data and present the CHW with a concrete
recommendation. Additionally, a computer-based system allows for easier review by the
supervising physician and auditing and analysis of both program process measures and
outcomes.
While CHWs will be acting on recommendations from the smartphone application without direct
physician supervision at that moment, they will in essence be acting on "standing orders"
from the physician because the treatment algorithms were designed by physicians and approved
by the SLM medical director. CHWs will also be able to obtain point-of-care treatment
recommendations from the medical director via telephone if there are questions about
application recommendations or if a situation arises that falls outside the scope of the
protocols.
