Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II
Sponsor: State University of New York at Buffalo

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February 20, 2009  
 
NCT00929838 
 
Protocol: Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM 
 
Principle Investigator: Leonard Egede, MD, MS 

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A: SPECIFIC AIMS  
Blacks (African Americans) with Type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer 
metabolic control, and greater risk for complications and death compared to Whites (NIH2002). Poor outcomes 
in Blacks with T2DM can be attributed to patient, provider, and health systems level factors (Egede 2005). 
Provider and health system factors account for <10% of variance in major diabetes outcomes including 
hemoglobin A1c (HbA1c), lipid control, and resource use (Hofer 1999, Krein 2002). Key differences appear to 
be at the patient level (Egede 2005). Of the patient level factors, consistent differences between Blacks and 
Whites with T2DM have been found in diabetes knowledge, self-management skills, empowerment, and 
perceived control (Egede 2005, Anderson 1991, Harris 1993, Egede 2004, Jack 2004, Egede 2003). This 
study provides a unique opportunity to address this gap in the literature. Using a 2x2 factorial design, this study 
will test the efficacy of separate and combined telephone-delivered, diabetes knowledge/information and 
motivation/behavioral skills training intervention in high risk Blacks with poorly controlled T2DM (HbA1c ≥9%).  
 
Primary Objective  
To test the separate and combined efficacy of a telephone-delivered diabetes knowledge/information and 
motivation/behavioral skills training intervention in improving HbA1c levels in Blacks with T2DM using a 2x2 
factorial design. 
 
Secondary Objectives 
1. To determine whether patients randomized to the telephone-delivered diabetes knowledge/information 
intervention, the telephone-delivered motivation/behavioral skills training intervention, or the combined 
intervention will have greater improvement in physical activity, diet, medication adherence, and self-monitoring 
of blood glucose at 12 months of follow-up compared to usual care. 
 
2.  To determine the cost-effectiveness of each telephone intervention separately, and then in combination.  
 
 
The primary outcome is HbA1c level at 12 months of follow-up. HbA1c will be measured by obtaining 
blood specimens, physical activity will be measured by the 7-day physical activity recall, diet will be measured 
by the Block food frequency questionnaire, medication adherence will be measured by electronic medication 
event monitoring system, and self-monitoring of blood glucose will be measured by glucometer downloads. 
 
RESEARCH DESIGN AND METHODS 
Study Overview: We propose to test the efficacy of a combined telephone-delivered, diabetes 
knowledge/information and motivation/behavioral skills training intervention in high risk Blacks with poorly 
controlled T2DM (HbA1c ≥9%). Our aim is to determine whether a separate or combined telephone-delivered 
diabetes knowledge/information and motivation/behavioral skills training intervention will lead to greater 
improvements in glycemic control compared to usual care using a 2x2 factorial design. 232 African Americans 
with T2DM will be randomized to one of four groups: 1) telephone-delivered diabetes knowledge/information; 
2) telephone-delivered motivation/behavioral skills training; 3) combined telephone-delivered diabetes 
knowledge/information and motivation/behavioral skills training; and 4) usual care. The proposed patient-level 
intervention is based on the information-motivation-behavioral skills model and provides information, 
motivation, and behavioral skills training. The usual care group will receive weekly telephone-delivered general 
health education lasting 30 minutes every week for 12 weeks to control for attention. Study assessments will 
be performed by a blinded research assistant at baseline, 3, 6, and 12 months of follow-up. The primary 
outcome is HbA1c level at 12 months of follow-up.  
 
Study Population & Recruitment plan: 
Study clinics: The study sites for this study are primarily the MUSC general medicine, endocrine, family 
medicine, and community primary care clinics. The study will be conducted out of the MUSC Center for Health 
Disparities Research.  
Participant Payment:  Participants will receive $25 for completion of baseline assessment materials, $25 for the 
3-month assessment, $25 for the 6-month assessment, and $25 for completion of the 12-month follow-up 
assessment. 

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Attrition and Retention: Based on prior experience with this population, we anticipate a 15% attrition rate in 12 
months. To account for this under an intent-to-treat analysis plan, we increased the sample size for 15% 
attrition. We will enroll 232 patients (n=58 per group). We intend to minimize drop out from the study by 
providing monetary compensation for completing the study. In addition, at enrollment, following consent, we 
will request from every participant, the names, addresses, and telephone numbers of a next of kin who would 
know how to get in touch with the participant, in the event of a missed appointment. 
Patient eligibility criteria: The study inclusion and exclusion criteria are as follows 
Inclusion Criteria: 1) Age ≥18 years; 2) Clinical diagnosis of T2DM and HbA1c ≥9% at the screening visit; 3) 
Self-identified as Black or African American; 4) Subject must be taking at least one oral medication for 
diabetes, hypertension, or hyperlipidemia and must be willing to use the MEMS cap and bottle for 12 months; 
5) Subjects must be able to communicate in English; and 6) Subjects must have access to a telephone 
(landline or cell phone) for the 12 week intervention period. 
Exclusion Criteria: 1) Mental confusion on interview suggesting significant dementia; 2) Participation in other 
diabetes clinical trials; 3) Alcohol or drug abuse/dependency; 5) Active psychosis or acute mental disorder; and 
5) Life expectancy <6 months. 
 
Description of Intervention: The proposed separate and combined diabetes education and behavioral skills 
training intervention are based on the information-motivation-behavioral skills model and provide information, 
motivation, and behavioral skills training. The interventions will be delivered via weekly telephone calls over a 
12-week period by trained diabetes educators. Two full-time diabetes educators will deliver the interventions. 
Each full-time educator will only be responsible for providing care to subjects in all the four study arms (i.e. 
knowledge/information, motivation/behavioral skills, combined, or usual care). Diabetes educators will be 
trained in behavioral skills counseling by study consultant.  
 
Baseline Visit & follow-up visits: At the baseline visit, the RA will give detailed explanation of the study, the 
reimbursement schedule, and obtain consent. Subjects will get their blood pressure measured and provide 
blood specimen to measure HbA1c. In addition, subjects will complete a questionnaire that captures 
demographics, medical history, HRQOL, physical activity, home blood glucose monitoring, resource utilization, 
and medication adherence. After the baseline assessment, follow-up assessments will be conducted at 3-, 6-, 
and 12 months. As much as possible, research visits will be scheduled on the same day as their clinic visit.  
Primary Outcome Measure: 
HbA1c/Fasting Lipid Profile: Blood specimens will be obtained at baseline, 3-, 6- and 12-months visits by 
trained phlebotomists. About 10cc of blood will be drawn and sent to the laboratory for HbA1c.  Fasting lipids 
will also be measured at baseline, 3-, 6-, and 12 months. 
 
Patient Randomization Procedures: All subjects who sign an informed consent for the study, meet eligibility 
requirements and are randomized will be entered into the study database. The research coordinator will collect 
the pre-specified eligibility information (written informed consent, demographics, eligibility criteria) and enter 
the information into the study database via the secured study website. Personal health information (PHI), e.g., 
name, medical record number, social security number, will not be entered into the study database. When all 
pre-specified information is entered for the patient, the project-specific computer program will confirm the 
eligibility of that patient. Once confirmed, the computer will generate the intervention assignment based on a 
pre-programmed randomization scheme. A confirmation report will be generated by the computer and will 
include the subject’s study ID number, assigned treatment date of randomization, basic demographics (age, 
gender) and eligibility criteria compliance. This report will be filed at the primary center in the confidential study 
specific files. All registered patients who are screened yet do not get randomized will have specific screening 
information entered into the study database.  
 
Sample Size and Power 
The proposed sample size calculations are based on the premise that we will test three hypotheses in this 2x2 
factorial 
design: 
1) 
the 
overall 
effect 
of 
diabetes 
knowledge/information 
versus 
no 
diabetes 
knowledge/information, 2) the overall effect of motivation/behavioral skills versus no motivation/behavioral 
skills, and 3) the effect of the combined interventions. The primary endpoint for testing these hypotheses is the 
12 month HbA1c value. Power calculations are based on the comparison of group means when accounting for 

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the baseline value (ANCOVA) with normally distributed data.  The model will have an intercept plus three 
coefficients: beta1 for the effect of diabetes knowledge/information, beta2 for the effect of motivation/behavioral 
skills and beta3 for the interaction effect. .The study has 85% power (2-sided type I error rate of 0.05) to detect 
a clinically relevant difference of 1 percentage point in the 12-month HbA1c (assuming a common standard 
deviation of 1.5). The clinically relevant difference in HbA1c at 12 months is based upon the findings of a 
previous RCT of telephone-delivered diabetes intervention (Piette et. al., 2001) and our pilot study. Sample 
size estimation is based on a 2x2 factorial design and takes into account the potential interaction between the 
diabetes knowledge/information and motivation/behavioral skills intervention. A total of 42 subjects per arm is 
required to achieve 85% power (type I error rate of 0.05) to detect a clinically relevant difference of 1 
percentage point in the 12-month HbA1c (assuming a common standard deviation of 1.5). Because testing for 
an interaction can greatly increase the sample size and since interaction is not our specific interest, we chose 
to ensure that we have adequate power to detect main effects in the presence of an interaction. Thus the total 
number of subjects required for randomization is 168 subjects (42 per treatment arm). The total sample size is 
inflated by a factor of 1.38 to account for an anticipated 15% attrition rate in an intent-to-treat analysis 
(Friedman et al, 2003). Thus a total of 232 subjects will be randomized into this study.  
 
Data Analysis 
Primary and secondary data analyses will be conducted using the intent-to-treat population. This population is 
defined as all randomized subjects. Sensitivity analyses will be conducted by repeating the proposed analyses 
using the per protocol population which is defined as all randomized subjects who complete 12 months of 
follow up. Primary Objective: To test the separate and combined efficacy of a telephone-delivered diabetes 
knowledge/information and motivation/behavioral skills training intervention in improving HbA1c levels in 
Blacks with T2DM using a 2x2 factorial design. Preliminary analyses will be conducted to assess the similarity 
of the treatment arms based on collected variables. Univariate descriptive statistics and frequency distributions 
will be calculated, as appropriate for all variables along with two-sided 95% confidence intervals when 
appropriate. Study discontinuation (attrition) rates will be estimated for each group. The primary framework for 
analysis is analysis of covariance. Twelve-month HbA1c measurements (dependent variable) will be compared 
between 
treatment 
arms 
using 
a 
model-based 
approach 
with 
telephone-delivered 
diabetes 
knowledge/information, telephone-delivered motivation/behavioral skills training and the interaction of the two 
factors in the model along with baseline HbA1c as a covariate. A global test approach will be implemented in 
order to preserve the type I error rate (Green, Liu and O’Sullivan, 2002). A mixed model repeated measures 
analysis of covariance will be conducted as a secondary analysis to assess the difference in HbA1c levels over 
time. The model will include telephone-delivered diabetes knowledge/information and telephone-delivered 
motivation/behavioral skills training and the interaction of the two as factors in the model along with baseline 
HbA1c as a covariate.  A similar analysis plan using a global test approach as describe above will be 
implemented.  If the interaction is not significant, it will be dropped from the model.  Covariance structures will 
be assessed during the model-fitting process using SAS PROC MIXED.    
 
Project Timeline: We will randomize 232 patients in 4 cohorts of 58 patients every 6 months for 24 months, 
with an average of 10 patients randomized per month. Activities in Year 1 will include staff recruitment and 
training; establishing patient safety procedures; and purchase of study equipment and supplies. Recruitment of 
Cohort 1 will begin in month 7 of Year 1; while Cohort 4 will be recruited in month 1 of Year 3. Follow-up data 
collection for the Cohort 4 will be completed in month 6 of Year 4. Data cleaning and final data analyses will be 
take place in months 7-12 of Year 4.  Manuscripts will be prepared and submitted for publication in months 7-
12 of Year 3 and months 1-12 of Year 4. We plan to publish an initial paper within the first 24 months to 
describe the study design and expected outcomes.  
 

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HUMAN SUBJECTS RESEARCH 
 
PROTECTION OF HUMAN SUBJECTS 
 
RISKS TO THE SUBJECTS 
 
Human Subjects Involvement and Characteristics  
We will recruit 232 male and female African American patients with T2DM from MUSC general 
medicine, endocrine, and family medicine clinics. We will use two complementary approaches to identify 
eligible study subjects. The first method will consist of systematic identification of patients with type 2 diabetes. 
The second method will consist of referrals from primary care providers, other clinic staff such as nurses, or 
patients themselves in response to recruitment flyers for the study.  
 
Patient eligibility criteria: The study inclusion and exclusion criteria are as follows 
 
Inclusion Criteria: 1) Age ≥18 years; 2) Clinical diagnosis of T2DM and HbA1c ≥9% at the screening visit; 3) 
Self-identified as Black or African American; 4) Subject must be taking at least one oral medication for 
diabetes, hypertension, or hyperlipidemia and must be willing to use the MEMS cap and bottle for 12 months; 
5) Subjects must be able to communicate in English; and 6) Subjects must have access to a telephone 
(landline or cell phone) for the 12 week intervention period.  
 
Exclusion Criteria: 1) Mental confusion on interview suggesting significant dementia; 2) Participation in other 
diabetes clinical trials; 3) Alcohol or drug abuse/dependency; 5) Active psychosis or acute mental disorder; and 
5) Life expectancy <6 months. 
 
Sources of Materials  
 
1. Research Material & Data: Sources of research material include medical history, research questionnaires, 
blood pressure readings, and blood specimens. The questionnaires will obtain information about 
demographics, clinical history, diabetes self-care, resource use, depression, and quality of life. Patients will 
provide ~10cc of blood for laboratory testing.  
 
2. Linkages to Subjects: Subjects will provide identifying information in addition to research data. Paper 
documents pertaining to this study will be stored in locked file cabinets in both the clinical center and the data 
management center, and data will be entered into secure, password-protected databases developed for this 
study. A database of name, contact address, telephone number, and other research identification numbers will 
be stored separate from the study database, for purposes of audit by the sponsor (NIH) and MUSC IRB, if 
necessary. Access to study data will be limited to research personnel.  
 
3. Collection of Data and Specimens:  
Participants will be randomized to one of four groups: 1) telephone-delivered diabetes 
knowledge/information; 2) telephone-delivered motivation/behavioral skills training; 3) combined telephone-
delivered diabetes knowledge/information and motivation/behavioral skills training; and 4) usual care.  
c. Potential Risks  
Potential risks to the patient include possible violation of the patient’s privacy, discomfort with questions 
on the research questionnaire, discomfort and bleeding from blood draws, discomfort with BP measurement, 
and psychological distress. Details on how these risks will be minimized are discussed under adequacy of 
protection against risks below. 
 
ADEQUACY OF PROTECTION AGAINST RISKS  
 
Recruitment and Informed Consent 
We will use two complementary approaches to identify eligible study subjects. The first method will 
consist of systematic identification of patients with type 2 diabetes. The second method will consist of referrals 

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from primary care providers, other clinic staff such as nurses, or patients themselves in response to 
recruitment flyers for the study. 
 
Protection against Risk 
A. Patients will be protected against potential risks as follows: 
1. Psychological Distress: Because we will be administering a questionnaire that measures the presence of 
depression, we will take several steps to ensure the safety of all research participants. RAs will be trained by 
the PI to identify patients who meet criteria for depression on the PHQ-9. Subjects’ who screen positive for 
depression will be notified during the visit and verbally instructed to seek care from their primary health care 
provider (PCP). They will also be given the 24-hour MUSC crisis psychiatry telephone service and told to call if 
they experience acute worsening of symptoms before they can be seen by their PCP. 
2. Venipuncture (blood drawing): To reduce the risks of discomfort and bruising, venipuncture will be 
performed by trained personnel. To reduce the risk of fainting, blood will be drawn while subjects are in a 
seated position. The amount of blood that will be drawn, approximately 10cc, is not considered to pose a 
health risk for most adults. .  
3. Blood Pressure Measurement: To lessen any associated risks, blood pressure measurements will be 
performed only by trained personnel utilizing a standardized protocol. Subjects with elevated blood pressure 
will be advised to contact their primary care provider. Those with potentially life threatening blood pressure 
readings will be sent to a local emergency room for treatment. 
4. Administration of Research Questionnaires: Some participants might be offended by detailed questions 
about emotional or physical health status and impairment, and healthcare utilization. All participants will be 
informed at the outset that they may terminate participation at any point. Our past research suggests that data 
collection using these measures can be conducted without undue psychological distress or exacerbation of 
symptoms among study participants. 
5. Unknown risks: Subject participation in research may have other unknown risks. The researchers will 
advise subjects if they learn of emerging information that might alter subjects' decisions to participate in this 
study. 
 
B. Subjects requiring medical or other professional intervention for study-related events will be provided with 
appropriate and timely medical guidance by the PI. If adverse events occur during the conduct of this study, 
they will be reported to the IRB in accordance with the MUSC IRB Adverse Event Reporting Policy. The results 
of subjects’ clinical assessments will be available within a few weeks of their study visit. The principal 
investigator will review and advise subjects of these results by phone and, at their request; he will also advise 
their personal physician of the results. 
 
C. To protect against the potential risk of loss of confidentiality and/or breach of privacy, data will be compiled 
using codes in lieu of personal identifiers. Access to study data will be limited to research personnel. 
Development of and security oversight for the electronic database for this study will be performed by the study 
statistician. Paper documents pertaining to this study will be stored in locked file cabinets and electronic data 
will be entered into secure, password-protected databases developed for this study by the research assistants. 
The PI will perform periodic review of the data entry process to ensure accuracy of recording. When study 
results are published or presented, only aggregate reports of the results will be used and participants’ identity 
will not be revealed. A file of name, contact address, telephone number, and other research identification 
numbers will be stored separately on paper and on computer, for purposes of audit by the sponsor (NIH) and 
MUSC IRB, if necessary.   
 
3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS  
The intervention is expected to benefit patients, by increasing their knowledge of diabetes, activating 
and empowering them to better care for their diabetes, improving blood glucose and blood pressure control, 
and reducing their risk developing complications of diabetes. Patients in the usual care group will benefit by 
increasing their general health knowledge.  
 
4. IMPORTANCE OF KNOWLEDGE TO BE GAINED  

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The findings of this study, if successful, will lead to the implementation of this feasible, evidence-based 
intervention for high risk minority patients with T2DM. The study will provide new information on how to 
improve quality of care for diabetes in ethnic minorities and reduce the disproportionate burden of diabetes 
complications and deaths in ethnic minority groups with T2DM. 
 
5. DATA AND SAFETY MONITORING PLAN  
The data and safety monitoring plan will include an internal Data Safety Monitoring Committee (DSMC) and the 
institutional IRB.  The purpose of the DSMC and IRB are to ensure the safety of participants and the validity 
and integrity of the data. Summaries of adverse events reports or patient safety concerns raised by the IRB will 
be made to NIH in the yearly progress unless the nature of a particular event is such that it bears reporting to 
NIH immediately.  
 
DSMC: The internal DSMC will consist of the PI, biostatistician, co-investigators/consultants on the proposal, 
and a designated medical monitor The functions of the DSMC will include: 1) provide scientific oversight; 2) 
review all adverse effects or complications related to the study; 3) monitor accrual; 4) review summary reports 
relating to compliance with protocol requirements; and 5) provide advice on resource allocation. The DSMC will 
meet quarterly and as necessary by telephone. The recommendations of the DSMC will be reviewed and the 
PI will take appropriate corrective actions as needed.  
  
Institutional IRB: The IRB will review and approve the funded protocol, review patient and provider consent 
forms, ensure protection of patient privacy and safety, and monitor the study on an ongoing basis. Adverse 
events will be reported to the IRB as they occur. Annual reports to the IRB will indicate accrual rate, adverse 
events, new findings that may influence continuation of the study, and reports of the DSMB.  
 
INCLUSION OF CHILDREN 
 
Children (ages 18-21) are included in this study. Children under the age of 18 years are excluded 
because type 2 diabetes is not common in younger aged children. Based on our study clinic demographics, we 
estimate that children 18-21 years will comprise ~5% of the sample.  
 
 
INCLUSION OF WOMEN 
 
Both men and women will be included in this study. Based on our study clinic demographics, we 
estimate that women will constitute 50% of the sample. 
  
INCLUSION OF MINORITY GROUPS 
 
Only minority adults (African Americans) are included in this study. This is justified because of the high 
burden of diabetes and its complication in African Americans, and the paucity of data on effective interventions 
in this population. 
 

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