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Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM

Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00929838
Acronym
DM-TBSI
Enrollment
256
Registered
2009-06-30
Start date
2008-08-31
Completion date
2016-06-30
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALDiabetes Knowledge/Information

This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks.

BEHAVIORALMotivation/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.

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.

BEHAVIORALUsual Care

This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hemoglobin A1c (HbA1c) at 12 Months Post Randomization12-months post randomization

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Diabetes Knowledge/Information: This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks.
63
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). 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.
65
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. 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.
63
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. Usual Care: This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content.
64
Total255

Baseline characteristics

CharacteristicMotivation/Behavioral Skills ArmCombined Intervention ArmDiabetes Knowledge/Information ArmUsual Care ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
14 Participants15 Participants15 Participants12 Participants56 Participants
Age, Categorical
Between 18 and 65 years
51 Participants48 Participants48 Participants52 Participants199 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
65 Participants63 Participants63 Participants64 Participants255 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
25 Participants30 Participants28 Participants31 Participants114 Participants
Sex: Female, Male
Male
40 Participants33 Participants35 Participants33 Participants141 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 630 / 650 / 630 / 64
other
Total, other adverse events
0 / 630 / 650 / 630 / 64
serious
Total, serious adverse events
0 / 630 / 650 / 630 / 64

Outcome results

Primary

Hemoglobin A1c (HbA1c) at 12 Months Post Randomization

Time frame: 12-months post randomization

Population: Final analysis used baseline A1c analysis of covariance for differences in levels of A1c between the treatment groups at 12months with baseline A1c as covariate.

ArmMeasureValue (MEAN)Dispersion
Diabetes Knowledge/Information ArmHemoglobin A1c (HbA1c) at 12 Months Post Randomization9.3 percentage of glycosylated hemoglobinStandard Deviation 1.8
Motivation/Behavioral Skills ArmHemoglobin A1c (HbA1c) at 12 Months Post Randomization9.2 percentage of glycosylated hemoglobinStandard Deviation 2.1
Combined Intervention ArmHemoglobin A1c (HbA1c) at 12 Months Post Randomization9.2 percentage of glycosylated hemoglobinStandard Deviation 1.9
Usual Care ArmHemoglobin A1c (HbA1c) at 12 Months Post Randomization9.5 percentage of glycosylated hemoglobinStandard Deviation 2.5

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026