Clinical trial NCT00929838: Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
Official title: Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus, Non-Insulin-Dependent
Diabetes Mellitus, Noninsulin Dependent
Diabetes Mellitus, Type II
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus, Non-Insulin-Dependent
African Americans
Blacks
Randomized Controlled Trial
Controlled Clinical Trial
Behavioral Research
Behavioral Medicine
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-06-30
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) at 12 Months Post Randomization
timeFrame: 12-months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina (MUSC)
name: Leonard E Egede, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egede LE, Strom JL, Durkalski VL, Mauldin PD, Moran WP. Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetes. Trials. 2010 Mar 29;11:35. doi: 10.1186/1745-6215-11-35.
citation: Egede LE, Williams JS, Voronca DC, Gebregziabher M, Lynch CP. Telephone-Delivered Behavioral Skills Intervention for African American Adults with Type 2 Diabetes: A Randomized Controlled Trial. J Gen Intern Med. 2017 Jul;32(7):775-782. doi: 10.1007/s11606-017-4023-0. Epub 2017 Mar 23.