1. TITLE: RANDOMIZED TRIAL OF A HEALTH LITERACY INTERVENTION TO ENHANCE T2DM MEDICALLY
UNDERSERVED PATIENTS' ADHERENCE IN COMMUNITY HEALTH CENTER SETTINGS
This application addresses broad Challenge Area (05) Comparative Effectiveness Research (CER)
and specific Challenge Topic, 05MD-105 Health Literacy.
1. RESEARCH AREA:
With 90 million Americans experiencing suboptimal health care because they lack the ability to read,
understand, and/or act on health information, this proposed randomized, double blind, parallel group
clinical trial seeks to determine the comparative effectiveness of an integrated health
literacy/community health worker intervention juxtaposed standard diabetes support practice in
community health centers.4
The current shortage in healthcare professionals is at crisis proportions
in the United States, compromising the quality of healthcare provided, and putting patients at risk.
Particularly hard hit by both issues are community health centers (CHCs) that rely on the team
approach in providing services to medically underserved populations. A vital member of many CHCs
healthcare teams across the country is the community health worker, minimally trained, but often an
effective support services caregiver. 5
Currently, an estimated 55,000 community health workers
across the country are providing support services to a variety of healthcare providers. Ibid
However,
very little clinical evidence exists that examines the impact of the health literacy trained community
health worker on the many aspects on chronic disease management such patient adherence, self
management practice, and patient/provider communication. 6
Using community based participatory research as the theoretical framework, the focus of this double
blind parallel study is to compare the clinical effectiveness of health literacy trained community health
workers providing diabetes support services in community health centers with those who provide
standard support service care. An Institute of Medicine study identified health literacy/self
management as one of the critical 20 cross cutting measures needed to improve the health care
system in the United States.7
Health literacy is the ability of an individual to access, understand, and
use health-related information and services to make appropriate health decisions. 4
Low health
literacy barriers such as accessing services, understanding prescriptions, treatment directions,
promotion of healthy behaviors, and primary prevention underscore the self management/adherence
challenges requiring additional support beyond the clinical realm of most primary caregivers.
There is growing consensus that community health workers (CHW) are becoming important members
of the healthcare workforce as key community facilitators in eliminating health disparities among
racial, cultural, and economically disadvantaged populations. A position statement (2003) by the
American Association of Diabetes Educators endorses diabetes community health workers as
important members of the diabetes healthcare team who can facilitate community based diabetes
care and education, particularly in the areas of community health needs and cultural relevance. 8
A
small, but growing body of scientific evidence supports the role of community health workers as
beneficial to improving the psychosocial health needs of patients with type 2 diabetes. 5, 9, 10
Very few rigorously designed studies, however, have examined that role's clinical impact as it relates
to health literacy, self management, and patient adherence. Despite myriad diabetes self
management interventions that have been developed and tested, significant gaps remain in ethnic
and racial health disparities and low health literacy research. 14, 15
Unfortunately, self management
challenges such as low health literacy, patient adherence, and the clinical impact of community health
worker interventions in patient diabetes care still persist. Increased research in this area will provide a
variety of cost effective, systemic pathways such as self management education programs and
psychosocial support mechanisms reflective of the diverse, cultural healthcare needs of medically
underserved populations throughout the United States. 14

2. 2. THE CHALLENGE AND POTENTIAL IMPACT:
2a. What is the research opportunity, scientific knowledge gap or technology that will be
addressed?
Scientific Knowledge Gap: Little is known about the clinical effectiveness of health literacy and/or
community health worker interventions in community health centers serving medically underserved
populations. 10, 11
The first systematic review of the effectiveness of community health workers specific
to diabetes care was conducted in 2006 by Norris et al. The authors found “preliminary data
demonstrating improvements in participant knowledge and behavior. According to an Institute of
Medicine report, 90 million Americans do not have the capacity to adequately understand nor use
health information effectively regardless of socio economic status. Medically underserved populations
with chronic illness are particularly vulnerable. 4
Low health literacy is most often associated with a
number of negative health outcomes, including less use of preventive services, greater use of
hospitals and hospital emergency rooms, poor general health and mental health, and an increased
risk of death. 1
Community based participatory research provides an excellent research framework to examine the
comparative effectiveness of this proposed behavioral intervention targeting medically underserved
populations challenged by chronic disease self management practice. Inadequate health literacy may,
in fact, contribute to the disproportionate burden of diabetes-related problems among medically
underserved populations in low income rural and urban areas in the United States. Parker et al.
(2008) recommend that the following action strategies may be necessary to resolve many of the
existing inequities: use data to identify the most vulnerable populations; tailor our interventions to fit
high-risk populations; simplify materials so they are tailored to the individuals being served; and, in the
longer term, help build health literacy through diabetes education systems so patients can better act
on their own behalf in any health care setting. 12
There is a growing need to meet patients where they
are today. Trained community health workers can alleviate the current time burden placed on
providers in many instances and assist them with facilitating a smoother transition between patient
and provider in achieving better clinical outcomes. 11
Further research of high methodological quality, however, is needed to assess the effectiveness of
health literacy behavioral interventions on sustained glycemic control control and quality of life if
community health worker interventions are to become a standard in the team approach with improving
patient care. More behavioral work with medically underserved populations must be done to identify
the predictors and correlates of glycemic control. Behavioral theory must have more of integrative role
in future clinical studies to improve the understanding of behavior change in the self-management of
chronic illness such as diabetes. 13
2b. How broad is the potential impact in science and/or health? According to the American
Diabetes Association and the Center for Disease Control, 23.6 million Americans have diabetes, with
approximately a third undiagnosed and the total annual economic cost of diabetes in 2007 was
estimated to be $174 billion. An additional 57 million have pre-diabetes. In 2001, the Institute of
Medicine identified care coordination and self-management/health literacy as two of the twenty areas
in need of improvement in the U.S. health care delivery system that could benefit patients with many
different health problems. Improved health literacy was put forward as a condition necessary to
enable active self-management by patients for most conditions. 7
Patients with chronic illness who had
limited health literacy and/or low health literacy have been found to be less knowledgeable about
disease management and less likely to use preventive measures. 15
Clearly, improving self-care
management strategies among medically underserved populations with T2DM at community health
centers require the implementation of health literacy practices that are reflective of these vulnerable
populations being served.

3. An evidenced-based review study sponsored by the (2004) Agency for Healthcare Research and
Quality (AHRQ), Literacy and Health Outcomes, was the first in-depth study to identify and evaluate
systemically interventions for low-literacy patients. It documented the limited availability of current
research focused on patient-centered approaches that address the low health literacy challenges
associated with navigating the healthcare system, in addition to the issue of self-care. The
relationship between levels of education and health has long been known; research has established a
link between low levels of education and poor health outcomes, including a greater mortality risk. 15
2c. Which community (ies) will be affected?: On the local level, thirty-nine community health
centers in Massachusetts participate in at least one health disease collaborative (HDC). Mattapan
Community Health Center (83% < 200% of poverty) and Dorchester House Multi Service Center (82%
< 200% of poverty), located in two Boston neighborhoods, will be directly affected by this study. Both
study centers are generally representative of urban community health centers nationally.
Boston's overall population is 596,638. Boston's other than White non-Hispanics population is 50%;
its Black population accounts for 36% of the total Black population in the state. In the city itself,
Blacks, Hispanics, and Asians represent the Boston population by 25%, 16.4%, and 8.4%
respectively. The prevalence of diabetes has increased from 3.8% in 1994 to 6.4% in 2005. City of
Boston residents account for 84% of all hospitalizations for diabetes during 2003-2005. The
population below 200% of poverty level in the city of Boston is 35.2%.
Dorchester House Multi Service Center and Mattapan Community Health Center are currently
participating in a Richard and Susan Smith Family Foundation 5 year study on improving diabetes
care. Both are members of the Center for Community Health Education Research and Services
academic/community partnership network (CCHERS) based at Northeastern University which is a
collaborating partner in this study. (See Figure 1)
Figure 1
Both centers represent a microcosm of our changing national demographics. Thus, the findings from
this study will provide the data needed for CCHERS to launch a large scale national, demonstration
CHW/Health Literacy Clinical Trial
Research Sites
#
Annual
Visits
Federal Status
Primary Service
Area
Racial/
Ethnic
Composition
Economic Indications
Dorchester House Multi Service Center
21,321
110,000 FQHC
Dorchester
22% White Non Hispanic
30% Black/African American
13% Hispanic/Latino
29% Asian or Pacific Islander
5% Other
1% Unknown
82% < 200% of poverty
Mattapan Community Health Center
6,400
24,000 Section 330
Mattapan
1% White Non Hispanic
94% Black/African American
15% Hispanic/Latino
_% Cape Verdean
.2% Vietnamese
83% < 200% of poverty

4. study addressing the biopsychosocial/health literacy role of the community health worker in diabetes
care.
2d. What is (are) the size(s) of the community(ies): The neighborhood of Dorchester in Boston has
a population of 92,115 people with an ethnic makeup 32% White alone, 36% African American or
Black, 12% Hispanic or Latino, 11% Asian or Pacific Islander, <1% Native American, 4% some other
race, 5% two or more races. Dorchester House Multi-Service Center provides healthcare services for
over 50,000 primary care patient visits each year and 50,000 more visits in Behavioral Health,
Dentistry, the Eye Center, Podiatry and a variety of specialty clinics. They are a member of the Boston
Health Net and Carney Hospital. The Dorchester community is primarily working class and immigrant,
with patients from Vietnam (30% of our overall total), the Dominican Republic and Cape Verde.
The neighborhood of Mattapan has a population of 28,746 people with 77% African American and/or
Caribbean American. Mattapan Community Health Center (MCHC) is a federally qualified health
center (FQHC) providing comprehensive, affordable, and culturally appropriate healthcare services
annually to approximately 7000 African/American and/or Black patients through 26,000 visits in the
Boston neighborhoods of Mattapan, Dorchester, Roxbury and Hyde Park since 1972. The patient
profile served at the Mattapan Community Health Center reflects some of the most serious health
issues facing the uninsured and underserved residents of the city of Boston.
From a national perspective, nearly 40% of community health center patients across the nation are
uninsured. Another 35% of health center patients depend on Medicaid. Moreover, 71% of health
center patients have family incomes at or below 100% of poverty. Two-thirds of health center patients
are members of racial or ethnic minorities.
With 60 million uninsured in the US today, over 1,100 Community Health Centers, serving over 16
million people at 6,000 sites located throughout all 50 states and U.S. territories provide health care to
low-income and medically underserved Americans. Community health centers are local, non-profit,
community-owned and federally-supported. Seven out of ten Community Health Center patients live in
poverty. They serve one in every five low income uninsured individuals, one in nine Medicaid
beneficiaries, and one in four low income minorities. 3
According to the National Association of
Community Health Centers (NACHC) represents the nation’s health safety net, never turning anyone
away – regardless of insurance status or ability to pay. They are local, non-profit, community-owned
and federally funded. ibid
2e. Will the potential impact be major?
Providing validated clinical justification for incorporating community health worker interventions into
our primary care and public health systems has enormous national implications for diabetes self
management education programs, patient behavior change, health literacy, patient/provider
communication, and quality of life.
Presently, nearly half of all American adults--90 million people--have difficulty understanding and
using health information. There is a higher rate of hospitalization and use of emergency services
among patients with limited health literacy, according to a 2003 report from the Institute of Medicine
titled Health Literacy: A Prescription to End Confusion. 4
Limited health literacy may lead to billions of
dollars in avoidable health care costs. Access to quality healthcare, in large measure, will depend on
the health information literacy skills of not only patients, but healthcare providers as well. More policy
efforts should be focused on expanding the reach of self-management interventions to include
ethnically diverse populations across the spectrum of health literacy.

5. Interventions to improve access to care and quality of care for populations experiencing the greatest
disparities can also positively affect others. Similarly, many interventions that address the needs of
specific populations can benefit other populations, as providers can learn to adapt these skills in the
care of all patients, allowing for clearer, more effective communication and increased patient
understanding and engagement in their own treatment and care. Health literacy efforts to make the
health care system more equitable can therefore benefit the whole population, not just targeted
populations.
3. THE APPROACH:
3a. How will you attempt to explore or solve the stated research problem?
This double blind randomized study will explore the comparative effectiveness of a health literacy
behavioral intervention by using the following methodology:
Study population: Using a CBPR multi level recruitment and retention plan strategy, a total of 200
medically underserved adult patients with type 2 diabetes will be recruited from two community health
centers' adult diabetes programs, enrolled and randomized to either the control group or intervention
group. Participants will be compensated with quarterly paid stipends for their expertise as chronic
disease patients. Each community health center will have two nurse case management/community
health worker teams (NCM/CHWs). Each team will consist of one NCM and two CHWs responsible
for managing and monitoring the study participant groups.
Study design: A community based participatory research (CBPR) theoretical framework will guide
the design and implementation of this 12 month parallel, two-arm, double blind, multi site, randomized
behavioral intervention trial inclusive of intention to treat analysis protocol. Study investigators
(outcome assessors) and participants will be masked to treatment assignment. Appropriate IRB,
HIPAA, CBPR, and patient informed consent protocols will be satisfied prior to study implementation.
(See Figure 2) Included in the study design will be a process (inclusive of intent to treat methodology)
as well as outcomes evaluation component.
Intervention: Perform a randomized controlled trial (RCT) of a new health literacy educational
intervention designed to compare the clinical effectiveness of health literacy trained community health
workers providing diabetes support services in community health centers with NCM/CHW teams who
provide standard support services. Under the guidance of the CBPR/IRB approved protocol, 2
NCM/CHW teams stationed at each CHC and selected adult patients with type 2 diabetes from each
community health center will be randomized into two groups:
1. Standardized NCM/CHW diabetes support services, or
2. The same regimen plus integrated CHW health literacy interventions
This behavioral intervention consists of ten modules of health literacy training material designed
specifically for community health workers and is delivered in ten one-hour sessions within a four-
month period followed by at least quarterly maintenance sessions. The actual duration of the clinical
trial is 12 consecutive months. A1C, blood pressure, and cholesterol clinical assessments of the
patients in both groups will occur at baseline, 3, 6, 9 and 12 months. Patients in the intervention group
will also receive monthly in person or by telephone support sessions from their community health
worker. These visits will be critical in determining the comparative effectiveness of the two regimens.
Patients receiving NCM/CHW health literacy intervention support will be asked to attend two group
orientation sessions focused on providing the patient with instruction in the use of the diabetes
monitoring process, the importance of dietary management, and weight management. Those in the
control group will receive the standard diabetes support care offered at the community health center.

6. Sample CHW Health Literacy and Diabetes Self Management Education Module Training
Curriculum
PHILOSOPHICAL FOUNDATIONS
 Link learning to adults prior health consumer experiences, meeting the needs of broad cultural,
economic, and social groups; encompassing a variety of learning styles; and be specifically
targeted to client concerns and learning goals.
 Provide literacy learning experiences that are contextual and experiential.
 Involve adults in planning their own health literacy learning by using participatory, coaching
approaches linked to individual and community empowerment.
Community health worker (CHW) training schedule: Ten one-hour sessions within a four-month period
followed by at least quarterly maintenance sessions.
Module 1 The Role of Health Literacy in Diabetes Self Management Education
Module 2 The “5As” (ask, advise, agree, assist, and arrange) Model of Behavioral Counseling.
Module 3 Diabetes & Its Risk Factors
Module 4 Health Information Communication
Module 5 Diabetes Complications: Identification and Prevention
Module 6 Learning about Medications & Medical Care
Module 7 Living with Diabetes: Mobilizing Your Family and Friends
Module 8 Literacy and Health as Cultural and Social Practices
Module 9 The Relationship among Health Information, Literacy, &Patient Adherence
Module 10 Using the Internet to enhance Patient Self Management Strategies.
Once training is completed, each community health worker will initially meet individually with their
group of patients for one hour each. During that time, the community health worker along with the
patient will assess their goals as a team and design the patient's individual self management plan
(ISP) with the CHW incorporating the “5As” (ask, advise, agree, assist, and arrange) model of
behavioral counseling.17
After the initial meeting, the community health worker will follow up each
month with a check in phone call to the patient and meet in person with the patient on a quarterly
basis unless otherwise identified in the patient's self management plan. Determination of periodic
NCM check-ins during the course of the 12 month clinical trial will also be included in the initial ISP
advising session. Each CHW will maintain a written log of each encounter for entry into the study's
overall process and outcome evaluation plan.
Recruitment: Patient recruitment will entail a multifaceted recruitment approach including a patient
retention strategy such as quarterly stipends in its efforts to recruit and retain a total of 200 type 2
diabetes adult patients from both community health centers to participate in the study. Appropriate
CBPR, IRB, HIPAA, and informed patient consent protocols will be satisfied prior to study
implementation and patient recruitment activity. Study sample size: N= 200 eligible T2DM adult
patients meeting study criteria listed below:
Study Inclusion Criteria:
 Diagnosed with type 2 diabetes for at least one year duration
 Women > 21 yrs old
 Men> 21 yrs old
 English-speaking

7.  No mental health disorders (Exception: individuals with a diagnosis of depression or taking
anti-depressants)
 Telephone in home or easy access to one
 Able to understand and participate in the study protocol
 Functionally capable of meeting the activity goals
Study Exclusion Criteria
 An inability or unwillingness to give informed consent
 diagnosed with type 1 diabetes
 Non-English speaking
Benefits and Risks: Other than the inherent psycho-socio stressors of diabetes self management
expectations, there is very little risk associated with participating in this CBPR study. The potential
benefits of adhering to the CHC team (patient, CHW, & NCM) individually designed self management
plan interspersed with health literacy strategies far outweigh current practice. Both study benefits and
risks will be detailed in the patient consent form and accepted study participants will have an
opportunity to review and discuss them at the patient orientation session held prior to implementation
of the study.
Assessments: Study pre/post measures will consist of periodic assessment of clinical baselines,
participant satisfaction focus groups and key stakeholder interviews. Patient/CHW participants at the
outset of this clinical trial will complete 5 short validated measures:
a) The short-form Test of Functional Health Literacy in Adults (s-TOFHLA)1
b) The Spoken Knowledge in Low Literacy in Diabetes Scale SKILLED (2005)2
A 10-item tool that measures the literacy level of patients with diabetes.
c) Diabetes Concerns Assessment Form (2007)3
A pre-assessment tool that measures a patient’s behavioral and psychosocial concerns.
d) Diabetes Empowerment Scale (2000)4
A validated assessment that measures the psychosocial self-efficacy of people with diabetes.
e) Newest Vital Sign5
A bilingual, nutritional label health literacy assessment screening tool developed by the Pfizer
Clear Health Communication Initiative that takes 3 minutes to administer. (2006)
1
Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health
literacy. Patient Educ Couns. 1999;38:33-42.
2
Rothman RL, Malone R, Bryant B, Wolfe C, Padgett P, DeWalt DA, Weinberger M, Pignone M. The Spoken Knowledge in
Low Literacy in Diabetes scale: a diabetes knowledge scale for vulnerable patients. Diabetes Educ. 2005 Mar-Apr;31(2):215-
24.
3
Anderson, R. and Patrias, R. (2007). Getting Out Ahead: The Diabetes Concerns Assessment Form Clinical Diabetes
25:141-143
4
Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. (2000). The diabetes empowerment scale: a measure of
psychosocial self-efficacy. Diabetes Care 23:739–743
5
Osborn CY, Weiss BD, Davis TC, Skripkauskas S, Rodrigue C, Bass PF, Wolf MS. (2007). Measuring adult literacy in
health care: performance of the newest vital sign. Am J Health Behav. Sep-Oct;31 Suppl 1:S36-46.

8. The above instruments measuring behavioral and psycho social concerns, depression, and health
literacy will be re-administered at the time of clinical failure based on glycated hemoglobin, cholesterol
and blood sugar levels.
The primary outcome measures are HbA1c, blood pressure and cholesterol levels, health literacy
level, and self management.
Secondary outcome measures are quality of life, patient satisfaction, physical activity, eating
behavior, depression and determinants of behavior change.
Donabedian's evaluation model of care will be used to guide the evaluation process for this study.
The model includes organizational input, process, and outcome measures. Key stakeholders –
patients, community health workers, and nurse case managers will participate in participant
satisfaction focus group sessions to ascertain clinical trial experience and recommended next steps.
A community forum to discuss research findings will conclude this CBPR study's clinical trial activities.
Statistical analysis plan: A pre-post retrospective review of patient charts and diabetes registry
information will be used to establish and periodically monitor patient clinical baselines. Intention to
treat methodology will be incorporated in the overall analysis as well. Univariate and multivariate
analyses will be done to determine the impact of the intervention on patient outcomes. Other
analytical measures such as descriptive statistics, Chi-square tests, frequency distributions, and
ANOVA will be generated to examine correlations between demographic variables, such as years with
T2DM, health literacy scales, A1c, blood pressure, and cholesterol levels, and self efficacy. Both
assessment and clinical outcomes will be included in quantitative data analysis. Qualitative analysis
will identify focus group themes, sub-themes, response patterns and native concepts and coded
accordingly.
Sample size and power: For the planning purposes of this behavioral study, we estimate the
proportions failing disease control during the first year of managed care would be 40% in the control
group versus 15% in the intervention group. A minimum of 30 patients would be required to detect
this difference as statistically significant (P<0.05) with a power of about 50%. Assuming a loss to
follow-up of about 5%, approximately 45 patients would be recruited for each randomized regimen.
That number of participants would be sufficient to provide information regarding the merits of the
health literacy intervention and to provide data in planning a larger study. That number also should
provide data leading to enhanced CHW instructional programs using this behavioral model. If the
number of patients recruited is larger, the power of the test increases. At 100 patients per community
health center, the power for this same comparison would be about 80%. These calculations may be
subject to slight readjustment once the study's research team and collaborators meet with
administrative representatives (including IRB) from the community health center to reassess the
proposed CBPR framework and protocols before study implementation.
3b. How will your rationale and/or approach overcome existing challenges or barriers in the
field?
To insure study treatment fidelity, a study project evaluator, throughout the course of the study, will
monitor and document the implementation of the research team's CBPR research methodology and
process in addition to conducting an outcomes measures evaluation. A primary challenge for this
study is the potential bias often associated with testing behavioral interventions for chronic medical
conditions. 19
Unlike a drug/placebo trial, it is often very difficult to provide allocation concealment and
blind the outcome assessors for a group-based educational intervention, particularly within a busy and
fluid community health center environment. Therefore to minimize bias in this double blind study,
neither the researchers (outcomes assessors) nor the patients will be aware of patient treatment

9. assignment. The NCM/CHW teams, following project protocols, will coordinate group assignments
and follow up scheduling.
Another major challenge is patient retention. Project participants will be offered quarterly paid stipends
throughout the trial for their expertise as chronic disease patients with the objective of reducing
attrition.
Using a CBPR theoretical framework to guide the design and implementation of this behavioral
intervention study, this two year, double blind randomized control trial will involve CHC patients who
meet the study's inclusion criteria. Two Boston area community health centers (CHC) will participate
as research sites in the study. Each CHC will provide a control and intervention Nurse case
manager/community health workers (NCM/CHW) team, trained in ADA approved diabetes self
management education (DSME) guidelines integrated with health literacy techniques and strategies.
Each center's teams will utilize health literacy techniques in the experimental group patients while
control group led NCM/CHW teams will use standard DSME program practices. Research in this area
is limited; therefore, establishing a valid, bias free CBPR replicable baseline for this type of behavioral
intervention is crucial for future research efforts.
4. TIMELINE, MILESTONES, EXPECTED MEASURABLE OUTCOMES AND DELIVERABLES:
Provide a timeline for the proposed research indicating points where intermediate objectives will be assessed and
decisions will be made regarding the course and direction of the continuing research effort. Possible alternative
paths that may be followed at critical junctures in the project plan should be described and indicated on the
timeline.
The timeline listed below outlines the study time frame and is subject to readjustment after final IRB
approval. CBPR negotiations with community health centers are often delicate and unpredictable,
subject to a number of issues requiring a significant level of flexibility during the process of
implementing a research project management plan. Therefore, the traditional rigidity of the research
process must adapt to the organic nature of community health center environments – always
prepared to revise research strategies, without sacrificing research integrity, supportive of unforeseen
administrative and/or patient/provider contingencies. Those contingency areas subject to alternative
paths are indicated in the timeline listed below with an asterisk and alternate strategies will be
determined in consultation with CHC staff with in the context of CHC daily operational activities.
The T2DM Health Literacy - Community Health Worker Trial
Timeline
(2009-2011)
Months: 6 9 12 18 21 24
*Develop community based participatory research (CBPR) project
management plan
*Recruit, select, and orient eligible patient and CHW study participants
(including informed consent process)
*Administer pre patient/ behavioral and clinical assessments
Analyze patient assessments/select and orient group participants
*Conduct Clinical Trial and 3 month interval clinical assessments
*Administer post intervention patient behavioral and clinical assessments
Formative evaluation/project monthly reviews/ mid-project review
*Conduct CBPR patient/NCM/CHW project satisfaction focus group sessions
Project data analysis

10. Timeline Year 1 – The first year of the study will focus on the development of the CBPR project
management plan, IRB approval and monitoring of clinical trial protocols, patient/community health
worker recruitment and selection, training, pre/trial assessments and analysis, and first half of a year
long clinical trial.
Timeline Year 2 – The second year of the project will include the second half of the clinical trial. It will
also be dedicated to compiling and analyzing the findings collected from the trial activities conducted
prior to, during, and at the conclusion of the clinical trial (e.g. assessments, patient/NCM/CHW
satisfaction focus groups, key informant interviews, the CBPR community forum, and the project's
process and outcomes evaluation process).
Figure 2
Final project formative/summative evaluation report process
*CBPR Public Forum Closing Session
CBPR
Framework
Double Blind
Parallel Behavioral
Study
Dorchester Multi
Service Health
Center
100 Patients
Randomized
Project Research
Team
Researchers and
Patients masked re:
treatment assignment
Mattapan
Community
Health Center
100 Patients
Randomized
NCM/CHW
Diabetes Support
Health Literacy
(HL) Training
2NCM/4CHW
NCM/CHW
Diabetes Support
Health Literacy
(HL) Training
2NCM/4CHW
Intervention Group
Standard Care/HL
50 Patients
1NCM/2CHW
Intervention Group
Standard Care/HL
50 Patients
1NCM/2CHW
Control Group
Standard Care
50 Patients
1NCM/2CHW
Control Group
Standard Care
50 Patients
1NCM/2CHW

11. CHW/Health Literacy Research Team
This CBPR randomized, double blind behavioral intervention trial is fortunate to have assembled an
outstanding team of multidisciplinary researchers with individual expertise and knowledge base that
compliments and enhances the goals and objectives of this clinical trial. Prior to study
implementation, the entire research team will meet with the community health center (CHC)
administration staff representatives to design the CBPR protocols reflective of both CHC communities
involved in the study. Once the research design/project management plan has been approved by the
appropriate IRBs, then a systemic communication schedule will be established to collaborate with
team members on a regular basis. A secure study intranet will be established to seek their advice
and to update them on the progress of the study.
PROJECT MANAGEMENT TEAM
Lana W. Jackman, PhD, Principal Investigator, President of Mélange Information Services, Inc. and a
Research Associate of the Center for Community Health Education Research and Service, Inc.
(CCHERS). As President of the National Forum on Information Literacy and chair of the National ICT
Literacy Policy Council, Dr. Jackman has an extensive faculty/practitioner’s background in adult
teaching and learning theory and practice, multiple intelligence theory, information literacy, and
knowledge management for adult learners.
Beverley Russell, PhD, MPH, RN, Co-investigator and Director of Research and Evaluation at the
Center for Community Health Education Research and Service (CCHERS) at Northeastern University
is a public health nurse with extensive experience with vulnerable patient populations, having served
as an administrator of the public health nursing program for the Boston Department of Health and
Hospitals and on the staff of several community health centers in the city of Boston. Dr. Russell has
served as an investigator on several NIH funded research projects in partnerships with Harvard
Medical School and School of Public Health, Brigham and Women’s Hospital, Dana Farber Cancer
Institute, and the Boston Public Health Commission. She is comfortable with both quantitative and
qualitative methods, and interdisciplinary research partnerships.
John M. Weiner, Dr.P.H, XXIV Century Press, Inc., serves as the study’s biostatistics expert and is
also expert in text mining-knowledge utilization applications. Dr. Weiner was Professor of Medicine
and Director of the Information Systems Research Program at the University of Southern California
School of Medicine and Administrative Director of the Children’s Cancer Study Group. He also was
Research Professor of Public Health Informatics at University at Buffalo.
J. Richard Woy, PhD., an evaluation specialist, is a behavioral psychologist with years of experience
evaluating programs in the non-profit and federal government arena, will serve as our Data and Safety
Monitor and Process/Outcomes Evaluator.
PROJECT COLLABORATORS:
Elena T. Carbone, DrPH, RD, LDN is Associate Professor, Interim Department Head, Graduate
Program Director for the Department of Nutrition at the School of Public Health and Health Sciences,
at the University of Massachusetts, Amherst. Dr. Carbone's areas of expertise include diet-related
health information and outcomes for obesity, diabetes, cancer, and food safety education in low
income populations.
Elmer Freeman, M.S.W., Executive Director of the Center for Community Health Education Research
and Service, Inc. (CCHERS), and an adjunct assistant professor and Director of Urban Health

12. Programs and Policy for Bouvé College of Health Sciences at Northeastern University. Mr. Freeman
is a recognized expert in the implementation of models of community-based participatory research
(CBPR) and is a member of the NIH Director’s Council of Public Representatives.
Martha M. Funnell MS, RN, CDE is an internationally known clinical nurse specialist, certified
diabetes educator co-investigator at the University of Michigan Diabetes Research and Training
Center. Ms. Funnell will provides us with content expertise related to diabetes patient and health
professional education, patient empowerment/collaborative approach to diabetes care, and culture-
specific and community-based interventions through collaboration, consultation, training, curriculum
development and the development of other tangible materials.
Ben Gerber, M.D. is an internist/diabetes researcher who maintains a clinical practice at the
University of Illinois Chicago and whose areas of specialty include research in the field of diabetes as
it relates to medical informatics and vulnerable patient populations.