Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM (DM-TBSI)

July 10, 2024 updated by: Leonard Ehianu Egede, State University of New York at Buffalo
Blacks or African Americans have greater risk of and are more likely to die from type 2 diabetes (T2DM). Major barriers to effective diabetes care for Blacks include poor diabetes knowledge, self-management skills, empowerment, and perceived control. Few prior studies have tested interventions to address these barriers in combination, especially among Blacks who have the greatest burden of diabetes related complications. This study provides a unique opportunity to address this gap in the literature by testing the efficacy of separate and combined telephone-delivered, diabetes knowledge and motivation/behavioral skills training intervention in high risk Blacks with poorly controlled T2DM. The findings of this study, if successful, 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 this population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. Poor outcomes in Blacks with T2DM can be attributed to patient, provider, and health systems level factors. Provider and health system factors account for <10% of variance in major diabetes outcomes. Key differences appear to be at the patient level. 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. A variety of interventions to improve diabetes self-management have been tested including: 1) knowledge interventions; 2) lifestyle interventions; 3) skills training interventions; and 4) patient activation and empowerment interventions. Most of these interventions have been tested individually, but rarely have they been tested in combination, especially among Blacks who have the greatest burden of diabetes related complications. 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%). The primary objective is to test the separate and combined efficacy of a telephone-delivered diabetes knowledge/information intervention and motivation/behavioral skills training intervention in improving HbA1c levels in Blacks with T2DM using a 2x2 factorial design. The secondary objectives are: 1) To determine whether patients randomized to the telephone-delivered diabetes knowledge/information intervention, the 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; and 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. The secondary outcomes are cost-effectiveness of each telephone intervention separately, and then in combination, and change in physical activity, diet, medication adherence, and self-monitoring of blood glucose over 12 months of follow-up. The long-term goal of the project is to achieve improvement in diabetes-related outcomes in this patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • 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
  • 4) Active psychosis or acute mental disorder
  • 5) Life expectancy <6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diabetes Knowledge/Information Arm
Subjects randomized to the diabetes knowledge/information arm will complete 12 diabetes education modules over a 12-week period. The educational materials were developed based on guidelines for diabetes education by the American Diabetes Association. The content is based on the principles of the Adult Learning Theory. The information is designed to be relevant, person centered, and presented in a non-threatening manner. The modules are designed to be delivered via telephone in 10-15 minutes, so that the maximum contact time per telephone call including introduction and closing would not exceed 30 minutes.
Behavioral: Diabetes Knowledge/Information
This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks.
Experimental: Motivation/Behavioral Skills Arm
The motivation/behavioral skills intervention consists of patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks. The behavioral skills training will be focused on 4 behaviors - physical activity, diet, medication adherence, and glucose self-monitoring. Guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks (4 behaviors over 12 weeks).
Behavioral: Motivation/Behavioral Skills
This intervention consists of patient activation, patient empowerment, and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks.
Experimental: Combined Intervention Arm
The combined intervention group will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The behavioral skills training will be focused on 4 behaviors and guided by subjects' current problem areas and preferences, subjects will be asked to choose 1 of 4 behaviors to focus on every 3 weeks. The combined intervention group telephone sessions will last for 30 minutes.
Behavioral: Combined Intervention
This group will receive all components of the diabetes knowledge/information and the motivation/behavioral skills interventions via telephone lasting 30 minutes every week for 12 weeks.
Sham Comparator: Usual Care Arm
The usual care group will receive weekly telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention. Patients in the usual care group will continue to receive any usual diabetes education provided by the clinic staff; however, they will not receive targeted diabetes knowledge/information, activation, empowerment, or behavioral skills training.
Behavioral: Usual Care
This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hemoglobin A1c (HbA1c) at 12 Months Post Randomization
Time Frame: 12-months post randomization
12-months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leonard E Egede, MD, MS, Medical University of South Carolina (MUSC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DK81121
  • R01DK081121 (U.S. NIH Grant/Contract)
  • R01DK081121-01A1 (U.S. NIH Grant/Contract)
  • HR18334 (Other Identifier: Medical University of South Carolina)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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