The Management of Diabetes in Everyday Life Program
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/19/2016 |
| Start Date: | November 2016 |
| End Date: | May 2020 |
| Contact: | Bonnie L Binkley, MA |
| Email: | bbinkley@uthsc.edu |
| Phone: | 9014484168 |
Improving Self-Care Decisions of Medically Underserved African-Americans With Uncontrolled Diabetes: Effectiveness of Patient-Driven Text Messaging Versus Health Coaching
The overall goal of this study is to compare how well motivational messages (text messages
from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes
education materials (provided at the doctor's office) work to help African-American adults
with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is
difficult when you have diabetes, especially when patients have other medical conditions,
their diabetes is uncontrolled, and when they live in an area without many primary care
doctors. Many studies have show that encouraging text messages from the doctor's office and
health coaches can help people take better care of themselves. But before primary care
clinics around the country start trying to send texts, hire health coaches, or provide
additional educational materials it is critical for them to know which approach is more
likely to help.
This study will assign African-American diabetics to either text messages, health coaches,
or enhanced care to find out which one works better. The investigators especially want to
find out if one works better for people at highest risk. Lastly, the investigators want to
find out if messages or coaches help people improve their blood sugar, quality of life, and
their feelings about primary care.
The study will test messages, coaches, and enhanced care side by side in primary care
doctors' offices. The messaging and coaching programs will give patients pretty much the
same information, but in different ways. The text messages will be written carefully based
on each patient's needs and interests. The coaches will be trained in how to help people get
motivated and work to reach their health goals.
This study will include 1000 African-American adults, ages 35-75, with uncontrolled diabetes
and one or more additional chronic condition, living in medically underserved communities.
People will have to have a cell phone or smart phone with texting capability and be able to
use it to participate. 400 participants will get messages, 400 will get coaches, and 200
will receive enhanced care.
The investigators will be able to tell if messages and coaches work by seeing if people
improve their diabetes self-care decisions, and if their blood sugar, quality of life, and
feelings about primary care get better. The long-term study goal is to get primary care
clinics all over the country to start using motivational messages or health coaches if they
work well.
from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes
education materials (provided at the doctor's office) work to help African-American adults
with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is
difficult when you have diabetes, especially when patients have other medical conditions,
their diabetes is uncontrolled, and when they live in an area without many primary care
doctors. Many studies have show that encouraging text messages from the doctor's office and
health coaches can help people take better care of themselves. But before primary care
clinics around the country start trying to send texts, hire health coaches, or provide
additional educational materials it is critical for them to know which approach is more
likely to help.
This study will assign African-American diabetics to either text messages, health coaches,
or enhanced care to find out which one works better. The investigators especially want to
find out if one works better for people at highest risk. Lastly, the investigators want to
find out if messages or coaches help people improve their blood sugar, quality of life, and
their feelings about primary care.
The study will test messages, coaches, and enhanced care side by side in primary care
doctors' offices. The messaging and coaching programs will give patients pretty much the
same information, but in different ways. The text messages will be written carefully based
on each patient's needs and interests. The coaches will be trained in how to help people get
motivated and work to reach their health goals.
This study will include 1000 African-American adults, ages 35-75, with uncontrolled diabetes
and one or more additional chronic condition, living in medically underserved communities.
People will have to have a cell phone or smart phone with texting capability and be able to
use it to participate. 400 participants will get messages, 400 will get coaches, and 200
will receive enhanced care.
The investigators will be able to tell if messages and coaches work by seeing if people
improve their diabetes self-care decisions, and if their blood sugar, quality of life, and
feelings about primary care get better. The long-term study goal is to get primary care
clinics all over the country to start using motivational messages or health coaches if they
work well.
Background and Significance: There is a critical need to determine the comparative
effectiveness of text messaging (TM) and health coaching (HC) among African-Americans with
uncontrolled diabetes and multiple chronic conditions living in medically underserved areas
(MUA) and to identify which modality yields greater improvement in diabetes self-care
at-risk urban and rural subpopulations. Although numerous recent studies demonstrate the
effectiveness of either TM or HC in improving diabetes and other chronic disease self-care
behaviors, and to the knowledge of the investigators no information is available regarding
comparative effectiveness of these modalities in urban and rural subgroups. Prevalence of
diabetes, related comorbidities, poverty, obesity, food insecurity, and tobacco use is
higher in rural areas as compared with urban. Moreover, rural areas struggle to address
these needs because of lower access to transportation, primary care, specialty care,
diabetes education, and mental health resources. However, urban living has its own unique
set of problems—including increased stress and fear for one's physical safety—that may
impact the comparative effectiveness of HC and TM. Although there are HC studies that show
effectiveness in interventions either in rural or urban areas, there are no HC studies of
which the investigators are aware that specifically examine the differences in U.S. rural
and urban participants in regards to engagement rates and clinical outcomes from a health
coaching intervention. Similarly, telemedicine and mobile health approaches have been
particularly advocated for rural populations yet little evidence supports their comparative
benefit. The lack of comparative effectiveness of text messaging and health coaching for
diabetes self-care in vulnerable urban and rural subgroups represents a critical gap in
research that the study is designed to directly address. The study will compare both
strategies with enhanced usual care (EC) with diabetes educational materials.
Study Aims: As a result, this research will use a pragmatic randomized trial to determine
the comparative effectiveness of patient-driven TM versus HC versus EC for African-American
adults with uncontrolled diabetes and multiple chronic conditions in MUA with an emphasis on
identifying and quantifying important interactions between key baseline characteristics and
treatment arm. Specific aims include: Aim 1-Quantify the effectiveness of TM, HC, and EC in
improving the primary outcome measures (diabetes self-care activities related to general
diet, exercise and medication adherence); Aim 2-Determine the contributions of six key,
baseline patient characteristics: 1) urban vs. rural residence, 2) health literacy, 3)
medical complexity, 4) social complexity, 5) smart vs. cell phone ownership, and 6) age, to
the comparative effectiveness of TM, HC, and EC; and Aim 3-Quantify the effectiveness of TM,
HC, and EC in improving secondary outcomes of average blood sugar, quality of life, and
primary care engagement. The long-term objectives are to disseminate and foster
implementation of the results of this research in MUA nationwide to improve critical
self-care supports in primary care for our most vulnerable populations.
Overall study design: Pragmatic randomized clinical trial.
Main components of the intervention and comparator(s): The study will test two critical
strategies for patient engagement that may lead to substantive improvements in the quality
of care and outcomes most important to vulnerable patients with diabetes: 1) patient-driven
TM, and 2) patient-driven HC. The two parallel primary care-based and patient-driven study
interventions (i.e. TM and HC) have been designed to provide approximately the same content,
but with two alternative delivery mechanisms. TM will incorporate supportive cognitive
behavioral strategies to encourage improved diabetes self-care decisions and will be
tailored based on participant demographics, health literacy, preferences, treatment
self-regulation, perceived competency and reported barriers to self-care. Motivational
interviewing focused HC will aim to meet with participants for individual HC sessions
bi-monthly the first 2 months (Intensive Phase-4 sessions following randomization) followed
by monthly for remaining 8 months (12 sessions total) to provide support regarding
diet/weight loss, physical activity, and medication adherence tailored according to
patient-identified health goals. Both strategies will be compared with EC with diabetes
educational materials.
Study population: For the main comparative effectiveness analysis (Aim 1) the total sample
size (after dropouts) is N=800 with 40% randomized to the TM arm (N1=320), 40% to the HC arm
(N2=320), and 20% to the EC arm (N3 = 160). Participants include African-American adults,
ages 35-75, with uncontrolled diabetes and multiple chronic conditions, living in medically
underserved communities in the MidSouth who have a cell phone or smart phone with texting
capability and complete a two-week run-in period demonstrating responsiveness to TM.
Primary/secondary outcomes: The primary outcome measures assessing effectiveness include:
three (out of six total) subscales of the revised Summary of Diabetes Self-Care Activities
questionnaire assessing general diet, exercise, and medication adherence. Secondary outcomes
include: diabetes-specific quality of life using the Diabetes-39, primary care engagement
using National Health Interview Survey questions regarding delayed needed care, and average
blood sugar (A1c) obtained from medical records and reported in the DWPC-R.
Analytic methods: For Aim 1, in the context of repeated measures ANOVA, using t-tests within
arm to detect change from baseline to 12-months (Follow-up 3), power exceeds 0.99 for all
primary outcomes. For Aim 2, six analyses will assess heterogeneity of treatment effects by
evaluating the interaction of each key, dichotomized, baseline characteristic with treatment
arm, estimating means and standard errors of six subclasses, and within each characteristic
(e.g. low or high health literacy) testing for differences between TM and HC, TM and EC, and
HC and TM. Analyses for Aim 3 will be conducted as described above for Aim 1. With the
proposed sample sizes differences can be detected within either the rural or urban setting
on two-sided tests at alpha of 0.05 with power of 0.953, 0.779 and 0.829, respectively.
Thus, both the rural and urban subgroups will have adequate power to detect a meaningful
difference in effectiveness between each active arm and the EC arm. If the arms are
combined, ignoring rural and urban setting, the combined active arms will have > .999, .972,
and .985 respectively.
effectiveness of text messaging (TM) and health coaching (HC) among African-Americans with
uncontrolled diabetes and multiple chronic conditions living in medically underserved areas
(MUA) and to identify which modality yields greater improvement in diabetes self-care
at-risk urban and rural subpopulations. Although numerous recent studies demonstrate the
effectiveness of either TM or HC in improving diabetes and other chronic disease self-care
behaviors, and to the knowledge of the investigators no information is available regarding
comparative effectiveness of these modalities in urban and rural subgroups. Prevalence of
diabetes, related comorbidities, poverty, obesity, food insecurity, and tobacco use is
higher in rural areas as compared with urban. Moreover, rural areas struggle to address
these needs because of lower access to transportation, primary care, specialty care,
diabetes education, and mental health resources. However, urban living has its own unique
set of problems—including increased stress and fear for one's physical safety—that may
impact the comparative effectiveness of HC and TM. Although there are HC studies that show
effectiveness in interventions either in rural or urban areas, there are no HC studies of
which the investigators are aware that specifically examine the differences in U.S. rural
and urban participants in regards to engagement rates and clinical outcomes from a health
coaching intervention. Similarly, telemedicine and mobile health approaches have been
particularly advocated for rural populations yet little evidence supports their comparative
benefit. The lack of comparative effectiveness of text messaging and health coaching for
diabetes self-care in vulnerable urban and rural subgroups represents a critical gap in
research that the study is designed to directly address. The study will compare both
strategies with enhanced usual care (EC) with diabetes educational materials.
Study Aims: As a result, this research will use a pragmatic randomized trial to determine
the comparative effectiveness of patient-driven TM versus HC versus EC for African-American
adults with uncontrolled diabetes and multiple chronic conditions in MUA with an emphasis on
identifying and quantifying important interactions between key baseline characteristics and
treatment arm. Specific aims include: Aim 1-Quantify the effectiveness of TM, HC, and EC in
improving the primary outcome measures (diabetes self-care activities related to general
diet, exercise and medication adherence); Aim 2-Determine the contributions of six key,
baseline patient characteristics: 1) urban vs. rural residence, 2) health literacy, 3)
medical complexity, 4) social complexity, 5) smart vs. cell phone ownership, and 6) age, to
the comparative effectiveness of TM, HC, and EC; and Aim 3-Quantify the effectiveness of TM,
HC, and EC in improving secondary outcomes of average blood sugar, quality of life, and
primary care engagement. The long-term objectives are to disseminate and foster
implementation of the results of this research in MUA nationwide to improve critical
self-care supports in primary care for our most vulnerable populations.
Overall study design: Pragmatic randomized clinical trial.
Main components of the intervention and comparator(s): The study will test two critical
strategies for patient engagement that may lead to substantive improvements in the quality
of care and outcomes most important to vulnerable patients with diabetes: 1) patient-driven
TM, and 2) patient-driven HC. The two parallel primary care-based and patient-driven study
interventions (i.e. TM and HC) have been designed to provide approximately the same content,
but with two alternative delivery mechanisms. TM will incorporate supportive cognitive
behavioral strategies to encourage improved diabetes self-care decisions and will be
tailored based on participant demographics, health literacy, preferences, treatment
self-regulation, perceived competency and reported barriers to self-care. Motivational
interviewing focused HC will aim to meet with participants for individual HC sessions
bi-monthly the first 2 months (Intensive Phase-4 sessions following randomization) followed
by monthly for remaining 8 months (12 sessions total) to provide support regarding
diet/weight loss, physical activity, and medication adherence tailored according to
patient-identified health goals. Both strategies will be compared with EC with diabetes
educational materials.
Study population: For the main comparative effectiveness analysis (Aim 1) the total sample
size (after dropouts) is N=800 with 40% randomized to the TM arm (N1=320), 40% to the HC arm
(N2=320), and 20% to the EC arm (N3 = 160). Participants include African-American adults,
ages 35-75, with uncontrolled diabetes and multiple chronic conditions, living in medically
underserved communities in the MidSouth who have a cell phone or smart phone with texting
capability and complete a two-week run-in period demonstrating responsiveness to TM.
Primary/secondary outcomes: The primary outcome measures assessing effectiveness include:
three (out of six total) subscales of the revised Summary of Diabetes Self-Care Activities
questionnaire assessing general diet, exercise, and medication adherence. Secondary outcomes
include: diabetes-specific quality of life using the Diabetes-39, primary care engagement
using National Health Interview Survey questions regarding delayed needed care, and average
blood sugar (A1c) obtained from medical records and reported in the DWPC-R.
Analytic methods: For Aim 1, in the context of repeated measures ANOVA, using t-tests within
arm to detect change from baseline to 12-months (Follow-up 3), power exceeds 0.99 for all
primary outcomes. For Aim 2, six analyses will assess heterogeneity of treatment effects by
evaluating the interaction of each key, dichotomized, baseline characteristic with treatment
arm, estimating means and standard errors of six subclasses, and within each characteristic
(e.g. low or high health literacy) testing for differences between TM and HC, TM and EC, and
HC and TM. Analyses for Aim 3 will be conducted as described above for Aim 1. With the
proposed sample sizes differences can be detected within either the rural or urban setting
on two-sided tests at alpha of 0.05 with power of 0.953, 0.779 and 0.829, respectively.
Thus, both the rural and urban subgroups will have adequate power to detect a meaningful
difference in effectiveness between each active arm and the EC arm. If the arms are
combined, ignoring rural and urban setting, the combined active arms will have > .999, .972,
and .985 respectively.
Inclusion Criteria:
- self-identified African-American adults
- diagnosis of uncontrolled diabetes (HbA1C > 8)
- have at least one other of 13 chronic health conditions (hypertension, congestive
heart failure, coronary artery disease, cardiac arrhythmias, hyperlipidemia, stroke,
arthritis, asthma, cancer, chronic kidney disease, chronic obstructive pulmonary
disease, depression, and osteoporosis and excluding dementia)) using the CMS
ICD-9-CM-based definitions
- is receiving or will receive care at one of our identified clinical sites
- has a cell phone or smart phone with texting and voicemail capabilities
- is not planning to move from the area in the next year
- is able to provide informed consent
- is English speaking
- completes a two-week run-in period for text message and voice message use
Exclusion Criteria:
- inability to understand consent procedures
- Pregnant
- presence of an unstable psychiatric condition or dementia
- perceived unwillingness or inability to participate
- inability to successfully complete the text message and voice message screening test
- Plans to move from the area and change primary care physicians in the next year.
- Diagnosis of severe depression in the last six months
- Individuals with cognitive impairment will be excluded if they experience difficulty
either understanding, following directions, or communicating clearly with program
staff. Individuals will be excluded if they exhibit uncontrolled psychiatric symptoms
and/or behaviors that may present a danger to program staff or to the study
participants themselves.
We found this trial at
6
sites
Memphis, Tennessee 38109
Phone: 901-260-8500
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