Trial Outcomes & Findings for Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM (NCT NCT00929838)
NCT ID: NCT00929838
Last Updated: 2024-07-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
256 participants
Primary outcome timeframe
12-months post randomization
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
65
|
63
|
64
|
|
Overall Study
COMPLETED
|
53
|
56
|
53
|
55
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
Baseline characteristics by cohort
| Measure |
Diabetes Knowledge/Information Arm
n=63 Participants
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.
|
Motivation/Behavioral Skills Arm
n=65 Participants
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.
|
Combined Intervention Arm
n=63 Participants
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.
|
Usual Care Arm
n=64 Participants
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.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12-months post randomizationPopulation: 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.
Outcome measures
| Measure |
Diabetes Knowledge/Information Arm
n=63 Participants
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.
|
Motivation/Behavioral Skills Arm
n=65 Participants
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.
|
Combined Intervention Arm
n=63 Participants
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.
|
Usual Care Arm
n=64 Participants
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.
|
|---|---|---|---|---|
|
Hemoglobin A1c (HbA1c) at 12 Months Post Randomization
|
9.3 percentage of glycosylated hemoglobin
Standard Deviation 1.8
|
9.2 percentage of glycosylated hemoglobin
Standard Deviation 2.1
|
9.2 percentage of glycosylated hemoglobin
Standard Deviation 1.9
|
9.5 percentage of glycosylated hemoglobin
Standard Deviation 2.5
|
Adverse Events
Diabetes Knowledge/Information Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivation/Behavioral Skills Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place