A Mobile Health Intervention for Inner City Patients with Poorly

DIABETES TECHNOLOGY & THERAPEUTICS
Volume 14, Number 6, 2012
ª Mary Ann Liebert, Inc.
DOI: 10.1089/dia.2011.0252
ORIGINAL ARTICLE
A Mobile Health Intervention for Inner City Patients
with Poorly Controlled Diabetes: Proof-of-Concept
of the TExT-MED Program
Sanjay Arora, M.D.,1 Anne L. Peters, M.D.,2 Chad Agy, B.S.,3 and Michael Menchine, M.D., M.P.H.1
Abstract
Objective: Numerous mobile health (mHealth) interventions are being developed to aid in management of complex chronic
medical conditions. However, the acceptance of mHealth programs by low-income, bilingual populations has not yet been
evaluated. The Trial to Examine Text-based mHealth for Emergency department patients with Diabetes (TExT-MED) program is a text message–based mHealth program designed specifically for resource-poor patients with diabetes. We conducted
a prospective proof-of-concept trial to assess satisfaction and preliminary effectiveness of the TExT-MED program.
Research Design and Methods: A consecutive sample of adult patients in the emergency department with diabetes and a text
message–capable mobile phone was enrolled in the TExT-MED program. Participants received three text messages daily for 3
weeks in English or Spanish in the following domains: educational/motivational, medication reminders, healthy living
challenges, diabetes trivia, and links to free diabetes management tools.
Results: Twenty-three patients with diabetes (median hemoglobin A1c, 8.9%) were enrolled in TExT-MED. In the week before
TExT-MED, 56.5% of subjects reported eating fruits/vegetables daily versus 83% after, 43.5% reported exercising before
versus 74% after, and 74% reported performing foot checks before versus 85% after. Self-efficacy, measured by the Diabetes
Empowerment Scale—Short Form, improved from 3.9 to 4.2. Scores on the Morisky Medication Adherence Scale improved
more dramatically from 3.5 to 4.75. Ninety percent of participants indicated they would like to continue the program, and
100% would recommend the program to family or friends.
Conclusions: This pilot trial of the TExT-MED program demonstrated increased healthy behaviors, improved diabetes selfefficacy and medication adherence, and received excellent satisfaction scores in resource-poor, inner city patients with
diabetes.
Introduction
D
iabetes is an epidemic that disproportionately affects
minorities and the underserved1–8 (see Table 17 in Kung
7
et al. ). These individuals often lack access to primary care,
and many overuse the emergency department (ED) for both
acute and chronic care.9–11 In order to help bridge the gap
between urgent visits to the ED and connection to follow-up
care, we developed a mobile health (mHealth) text message–
based intervention to improve healthy behaviors, medication
adherence, and self-efficacy in low-income patients with
diabetes.
mHealth refers to the utilization of mobile phones and
other personal mobile devices as a platform on which to
provide public health or medical interventions. Currently, the
term encompasses a broad array of applications and technologies ranging from highly interactive Web-based social
media platforms to avatars representing a patient’s current
and predicted future health status, to simple broadcast text
message systems. Programs such as ‘‘Text4Baby,’’ a textbased intervention designed to promote maternal and child
health, and other text message–based mHealth programs
have been developed as adjunct management tools for patients with both acute and chronic diseases, including human
immunodeficiency virus and diabetes.12–15 However, most
existing diabetes mHealth programs are highly complex, involve bidirectional remote monitoring of glucose levels, and
require expensive smartphones to access applications (apps)
and the mobile Web. National data confirmed by our local
pilot work show that 80% of Spanish-speaking patients have
1
Department of Emergency Medicine and 2Division of Endocrinology and Metabolism, Department of Medicine, 3Keck School of Medicine,
University of Southern California, Los Angeles, California.
This study is registered at ClinicalTrials.gov with Trial Registration Identifier number NCT01403831.
492
DIABETES mHEALTH FOR INNER CITY PATIENTS
and use short message service message–capable mobile
phones, but very few have costly smart phones.16
To date no mHealth interventions have been reported describing use in a bilingual, underserved population in the
United States with diabetes. mHealth has the potential to be a
significant breakthrough for resource-poor, Spanish-speaking
patients if it is low cost, accessible, and easy to use. For
mHealth to be effective for resource-poor patients it must be
technologically familiar (short message service messages) and
easily scalable. To this end, we have developed the Trial to
Examine Text-based mHealth for Emergency department
patients with Diabetes (TExT-MED) program. TExT-MED is
designed to motivate, educate, and empower inner city patients with diabetes. This is a culturally sensitive, low-cost,
bilingual, evidence-based, and largely unidirectional text
message–based mHealth program requiring only a basic
mobile phone to use. We conducted a prospective proofof-concept study to assess satisfaction and preliminary effectiveness of the TExT-MED program.
Research Design and Methods
Study setting and patient selection
This prospective study was conducted in the ED at the Los
Angeles County Hospital at the University of Southern California, which is a public safety-net hospital, and the ED has
over 170,000 patient visits annually. A trained research assistant approached a consecutive sample of patients with a
documented medical history of diabetes in 8-h blocks for a
7-day period. The research assistant explained the purpose of
the study, described the TExT-MED intervention, and obtained written informed consent. Subjects were eligible for
inclusion if they were (1) ‡ 18 years old, (2) had diabetes, (3)
had a text message–capable mobile phone, (4) knew how to
receive text messages, and (5) spoke and read English or
Spanish. Exclusion criteria for the trial included (1) overt
psychosis, (2) inability to provide informed consent, and (3)
pregnancy. Enrolled subjects were given a $50 subject participation stipend to cover the potential costs associated with
the text messages and the follow-up visit. Institutional Review
Board approval for this study was obtained prior to study
initiation.
Study procedure and data collection
TExT-MED is a technologically simple solution using unidirectional daily text messages used to deliver health messages and triggers to promote knowledge, healthy eating,
493
exercise, self-efficacy, and medication adherence. In this
study, subjects received three text messages daily (9 a.m., 12
p.m., and 6 p.m.) on their mobile phone for 3 weeks. Messages
were delivered by a fully automated, Web-based program
developed by EPG Technologies (Van Nuys, CA). EPG staff
have undergone National Institutes of Health Human Subjects training, and their program met Institutional Review
Board and HIPAA privacy and security rules. Messages were
sent in English or Spanish according to patient preference. The
full schedule of messages organized by message type is detailed in Figure 1. The first text message was delivered while
the subject was still in the ED to ensure technical success and
read: ‘‘Thank you for participating in the TExT-MED Program. Together, we will conquer your diabetes.’’ Subsequent
text messages were divided into the following categories:
1. Educational and motivational (two per day). These
messages were largely adapted from the National Diabetes Education Program (NDEP). We chose to adapt
materials from the NDEP to text message format as they
are in the public domain, bilingual, non-branded,
written at a 5th grade reading level, and available in
both English and Spanish.12 Information from the
NDEP falls into the following content areas: Blood
Glucose Control, Blood Pressure, Cholesterol, Controlling Diabetes, Foot Care, Healthy Eating, Heart Disease,
Physical Activity, Recipes, Social Support, and Teens
and Diabetes. Most NDEP key points are already
written in short statements that were easily translatable
to 160 7-bit character text messages. Through an iterative process involving physician specialists in endocrinology and emergency medicine and a certified
diabetes educator, we selected messages representing
all NDEP content areas focusing on specific areas of
knowledge deficit we have identified in previous
studies with Los Angeles County Hospital at the University of Southern California ED patients (e.g., signs of
high and low blood sugar, wound care management,
and elements of a healthy diet).18 Sample educational
and motivational text messages included ‘‘Having diabetes can lead to a heart attack or stroke—but it doesn’t
have to,’’ ‘‘Controlling your blood glucose, blood pressure, and cholesterol—can mean a longer and healthier
life,’’ and ‘‘Eat more fruits, vegetables, beans, and whole
grains and less salt and fat.’’
2. Medication reminders (three per week). These messages
were developed to provide a trigger that would result
Monday
Tuesday
Wednesday
Thursday
9 a.m.
Medication
Reminder
Healthy
Living
Challenge
Medication
Reminder
12 p.m.
Educate/
Motivate
Educate/
Motivate
6 p.m.
Educate/
Motivate
Educate/
Motivate
FIG. 1.
Friday
Saturday
Trivia
Medication
Reminder
Healthy
Living
Challenge
Phone
Link
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Educate/
Motivate
Weekly schedule of text message types.
Sunday
494
in increasing patient adherence with prescribed medications. The message read: ‘‘Remember to take your
medications every day as prescribed by your doctor.’’
3. Healthy living challenges (two per week). These messages were designed to provide patients a concrete,
attainable goal for the day. The challenges were based
on healthy living principles set forth by the Amereican
Diabetes Association and the NDEP. Sample challenge
messages included ‘‘Challenge! Don’t drink any soda or
juice today. Only drink water or milk,’’ ‘‘Challenge! Eat
one meal today that has only vegetables,’’ and ‘‘Challenge! Look at food labels and find a snack that has less
than 100 calories.’’
4. Trivia (one per week). These messages were derived
from NDEP materials, designed to educate and motivate, and presented in question form. This was the only
portion of the TExT-MED program that gave the participants an option to reply to received messages.
Sample trivia texts included ‘‘What is a normal blood
sugar level?’’
5. Phone links (one per week). These messages provided
patients with a phone number to call if they wanted to
receive a free gift to help them manage their diabetes.
This provided them with another way to interact with
us that was not text message based. Sample offered gifts
included a diabetes book and a pedometer.
Measures
Subjects provided demographic, clinical, and biometric
data at the index ED visit. Hemoglobin A1c (HbA1C) was
measured at the index visit using the Afinion AS-100 (AxisShield PoC AS, Oslo, Norway) capillary point-of-care HbA1C
meter, which reports National Glycohemoglobin Standardization Program–aligned values. At both the index visit and
upon completion of the 3-week trial, patients were asked
questions about their engagement in healthy behaviors over
the preceding 7 days (specifically, diet, exercise, and foot
care), completed the Diabetes Knowledge Test (DKT) developed by the Michigan Diabetes Research Training Center, the
Diabetes Empowerment Scale—Short Form (DES-SF), and the
eight-item Morisky Medication Adherence Scale (MMAS).19–22
In addition, at the exit interview subjects were asked if they
completed each of the six individual challenges and were then
given a series of Likert-type questions assessing various aspects of the TExT-MED program including (1) perceived efficacy of the program, (2) opinions on the different types and
frequency of text messages, (3) the appropriateness of the level of the text message content, and (4) their willingness to
continue with or recommend the TExT-MED program to
family or friends.
Analysis
The analysis is largely descriptive with point estimates and
appropriate 95% confidence limits displayed. No formal statistical test of hypothesis was conducted. Analyses were
performed with Stata version 10.1 (StataCorp, College Station,
TX). The DKT, DES-SF, and MMAS were scored according to
previous reports.19–22 Likert-type questions were dichotomized into a positive response if ‘‘strongly agree’’ or ‘‘somewhat agree’’ was selected and a negative response if ‘‘neutral,’’
ARORA ET AL.
‘‘somewhat disagree,’’ or ‘‘strongly disagree’’ was selected.
We did not conduct a formal sample size calculation for this
proof-of-concept study. Rather, we chose enroll patients in the
study over a 1-week period based on locally available
resources.
Results
Participants
In the 1-week enrollment period, we identified 83 ED patients with diabetes. Of these, six were excluded because of
inability to speak English or Spanish, and three were excluded
because of inability to provide informed consent secondary to
altered mental status. Of the remaining 74 patients, 51 did not
have a text message–capable phone or indicated they did not
know how to receive text messages. This left 23 patients eligible, and all 23 of these were enrolled. Mean age of subjects
was 45 years, 60% were male, 70% were Latino, and 30%
opted to received messages in Spanish. Further characteristics
of the study population are detailed in Table 1.
Main results
Median HbA1C on enrollment was 8.9%, indicating poor
glycemic control. At the end of the 3-week trial, 20 of the 23
(87.0%) subjects returned to complete the exit interview and
follow-up questionnaire. Globally, the TExT-MED program
was associated with improved health behaviors: in the week
before TExT-MED, 56.5% of subjects reported eating fruits/
vegetables daily versus 83% after, 43.5% reported engaging in
any form of exercise before versus 74% after, and 74% reported performing any foot checks in the week before the
intervention versus 85% after. Seventy percent of patients
performed at least four of the six health challenges. Selfefficacy, as measured by the DES-SF, improved modestly
during the trial (from 3.9 to 4.2). Scores on the MMAS improved more dramatically, from 3.5 to 4.75. When the aspects
of the program requiring bidirectional interactions were
examined, only two patients called in response to the phone
link messages, and only eight patients responded to any of the
trivia messages. Scores on the DKT did not change meaningfully (from 8.7 at baseline to 8.4 post-intervention).
Table 1. Characteristics of Study Participants
Demographic
Number
Age (years) [mean (SD, range)]
Gender (male)
Ethnicity
Latino/Hispanic
Non-Latino/non-Hispanic
Language preference
English
Spanish
BMI (kg/m2) [mean (SD, range)]
HbA1C [median (SD, range)]
Diabetes type
Type 1
Type 2
Not sure
Value
23
45.4 (7.5, 36–63)
61%
70%
30%
70%
30%
32.1 (5.4, 23.4–45.4)
8.9% (2.2, 5.7–14.1%)
BMI, body mass index; HbA1C, hemoglobin A1c.
9%
70%
21%
DIABETES mHEALTH FOR INNER CITY PATIENTS
Satisfaction with TExT-MED program
Overall, subjects reported high levels of satisfaction with
the TExT-MED program. Specifically, 90% of participants indicated they would personally like to continue the program,
and 100% would recommend the program to family or
friends. Similarly, 90% of participants agreed that text messages were an effective way of communicating, that the
messages were understandable, and that they liked receiving
them every day of the week. Table 2 gives further details of the
satisfaction responses.
Conclusions
mHealth technologies have garnered significant interest
and enthusiasm from public health advocates, policy makers,
and the technology industry. The range of mHealth interventions being developed and tested is wide and includes
simple unidirectional text-based systems to virtual worlds in
which current behaviors are projected forward in time onto
avatars to demonstrate the future effects of present lifestyle
choices. The clinical and public health efficacy of mHealth is
only beginning to be rigorously assessed, but initial results are
encouraging.12–15 However, the effect of mHealth programs
on resource-poor, inner city populations is wholly unknown.
The TExT-MED program was designed specifically for resource-poor patients with the belief that a successful mHealth
intervention in this population should use a basic technology
that they already have and are familiar with (text messages)
and that the information provided should be simple and easy
to understand. To be a sustainable on a system-wide scale and
widely disseminated, it should be low cost, easy to implement, and readily adaptable.
Patients with diabetes who use the ED for care may represent an excellent target for brief, scalable, diabetes-specific
interventions such as TExT-MED. Over the last decade, there
has been a 5.6% relative annual increase in the proportion of
Table 2. Reported Satisfaction
with the TExT-MED Program
Statement
Using text messages is a good way to teach
I have enjoyed the TExT-MED program
I was able to understand all the messages
The number of text messages per day
was just right
I liked getting text messages on the weekdays
I liked getting text messages on the weekends
The text messages came at times that
were good for me
I would like to continue receiving text messages
I would recommend this program to a friend
or family member
I was motivated by the challenges
I liked the weekly trivia questions
The medication reminders helped me remember
to take my meds
The number of medication reminders
was just right
Participants
who agreed
(n = 20)
90%
90%
100%
70%
80%
80%
95%
90%
100%
80%
80%
90%
90%
TExT-MED, Trial to Examine Text-based mHealth for Emergency
department patients with Diabetes.
495
ED visits that were diabetes-related.11 Recent studies show
that 11–27% of ED patients suffer from diabetes and that poor
glycemic control is common (in our sample, median HbA1C
was 8.9%).9,10 Furthermore, it has been reported that ED patients with diabetes, particularly those seen in a public safetynet system, are often poorly educated, have limited English
language skills, are in poor physical health, and have insufficient access to traditional medical homes.10 Unfortunately,
the ED is overcrowded and ill prepared to provide chronic
disease management for these patients. Our proof-of-concept
study in an urban ED shows that TExT-MED was highly accepted as patients were engaged and reported overwhelmingly positive satisfaction scores. It is unusual to have 100% of
eligible patients agree to participate in a study, but we feel this
level of enthusiasm speaks to the enormous potential that
mHealth has to impact this population. The intervention also
appeared to be effective in our sample as healthy behaviors,
diabetes self-efficacy, and medication adherence increased. It
is interesting that these positive behavior changes occurred
without an increase in diabetes-specific knowledge, suggesting that improved knowledge may not be required to impact
outcomes. In addition, all patients completed at least four of
the six provided healthy living challenges. The trivia texts and
phone links were less engaged (only two patients engaged in
the phone link), which supports the concept that unidirectional text message programs may be more readily accepted
in this patient population.
Ours is the first study we are aware of describing a bilingual mHealth program for low-income patients with diabetes.
Other groups have conducted studies aimed at improving
diabetes control via text-based mHealth in different patient
populations. Franklin et al.12 conducted a study of 92 pediatric patients with type 1 diabetes in Scotland, sending one or
two text messages daily consisting of personalized insulin
injection regimens, healthy eating tips, and exercise goals for
the week; the ‘‘Sweet Talk’’ intervention showed improved
HbA1C at 1 year only when combined with intensive insulin
therapy, but ‘‘Sweet Talk’’ alone improved diabetes selfefficacy and medication adherence. Kollman et al.14 published
results of a pilot study requiring patients to send daily blood
glucose values via text messages to a central monitoring
center, and patients would receive personalized text messages
in the evening based on reported values. Although there was
a trend towards decreased HbA1C and average blood glucose, their system is highly involved and bidirectional and
driven primarily by active subject engagement. Kim13 designed a randomized control trial of 60 patients with type 2
diabetes in Korea in which patients in the intervention group
sent daily blood glucose values to a Web server and based on
these data would receive individualized management strategies via text messages; although effective in decreasing
HbA1C by 1.15% at 12 weeks, this system was also bidirectional, involved using the Internet, and required ongoing
physician involvement to create management strategies.
A relative strength of this study and the TExT-MED program is that it demonstrates the potential of simple, scalable,
unidirectional text messaging to encourage positive behavior
change. Moreover, the study was successful despite being
conducted in the ED, a clinical area not typically associated
with chronic disease management. This study is limited by its
small sample size, uncontrolled design, and short follow-up
period, which prevented us from evaluating for a measurable
496
change in HbA1C. Another important consideration that may
limit the generalizability of these findings is that some patients may incur a cost associated with the receipt of text
messages. Researchers and program designers should be
cognizant of this when these programs are widely distributed.
Of note is that in our study all subjects already had unlimited text message plans prior to enrollment. Additionally, in
our study 31% of subjects with diabetes had a text message–
capable phone and knew how to receive text messages. This
limits the potential reach of similar mobile phone–based interventions. However, 31% of patients with diabetes still
represents over 8 million individuals in the United States who
could benefit from mHealth.
In conclusion, our proof-of-concept text-based program for
low-income, resource-poor patients with diabetes resulted in
excellent satisfaction and modest improvement in self-care
behaviors after 3 weeks. These results suggest TExT-MED has
the potential to impact a hard-to-reach patient population. We
are conducting a larger, randomized controlled trial to confirm these findings.
Acknowledgments
This study was supported by a grant from the McKesson
Foundation as a part of their mobilizing for health initiative.
S.A. conceived of the project, helped design the study, participated in the development of the text message curriculum,
and contributed to the writing and revision of the manuscript.
A.L.P. helped design the study, participated in the development of the text message curriculum, and contributed to the
writing and revision of the manuscript. C.A. helped design
the study, participated in the development of the text message
curriculum, and assisted with collection of data. M.M. helped
design the study, performed all statistical analyses, and
helped write and revise the manuscript.
Author Disclosure Statement
The authors have no conflicts of interest and no financial or
other ties to report.
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Address correspondence to:
Sanjay Arora, M.D.
Department of Emergency Medicine
Keck School of Medicine
University of Southern California
1200 North State Street, Room 1011
Los Angeles, CA 90033
E-mail: [email protected]