Trial Outcomes & Findings for An Educational Intervention for Type 2 Diabetes Patients (NCT NCT01671345)
NCT ID: NCT01671345
Last Updated: 2019-03-11
Results Overview
Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.
COMPLETED
NA
169 participants
at the baseline ( Visit 1) and post-intervention (Visit 2)
2019-03-11
Participant Flow
Eligible patients (active diagnosis of type 2 diabetes mellitus and a hemoglobin A1c ≥ 7.5) were identified and recruited from the Primary Care clinic and Women's clinics at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago. Recruitment period lasted from 11/27/13 to 11/30/16.
794 patients were screened; 625 were excluded (not meeting inclusion criteria -188, declined participation/did not respond to invite - 437). 169 patients were enrolled.
Participant milestones
| Measure |
Intervention
Patients randomized to the intervention view the intervention video.
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.
|
Control
Patients randomized to control view an informative video about diet and nutrition of similar length.
Control: Attention control.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
92
|
|
Overall Study
COMPLETED
|
64
|
83
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
| Measure |
Intervention
Patients randomized to the intervention view the intervention video.
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.
|
Control
Patients randomized to control view an informative video about diet and nutrition of similar length.
Control: Attention control.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
6
|
|
Overall Study
visit with non-participating physician
|
3
|
3
|
Baseline Characteristics
An Educational Intervention for Type 2 Diabetes Patients
Baseline characteristics by cohort
| Measure |
Intervention
n=64 Participants
Patients randomized to the intervention view the intervention video.
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.
|
Control
n=83 Participants
Patients randomized to control view an informative video about diet and nutrition of similar length.
Control: Attention control.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Age, Continuous
|
60.19 years
STANDARD_DEVIATION 7.78 • n=93 Participants
|
59.50 years
STANDARD_DEVIATION 8.21 • n=4 Participants
|
59.89 years
STANDARD_DEVIATION 7.95 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
64 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at the baseline ( Visit 1) and post-intervention (Visit 2)Population: Patients with type 2 diabetes and with HgbA1c more than or equal to 7.5
Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.
Outcome measures
| Measure |
Intervention
n=64 Participants
Patients randomized to the intervention view the intervention video.
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.
|
Control
n=83 Participants
Patients randomized to control view an informative video about diet and nutrition of similar length.
Control: Attention control
|
|---|---|---|
|
Patients' Perceived Self-efficacy to Communicate
Visit 1
|
22.11 units on a scale
Standard Deviation 3.24
|
22.14 units on a scale
Standard Deviation 3.06
|
|
Patients' Perceived Self-efficacy to Communicate
Visit 2
|
23.44 units on a scale
Standard Deviation 2.40
|
22.63 units on a scale
Standard Deviation 2.99
|
PRIMARY outcome
Timeframe: at the baseline ( Visit 1) and post-intervention (Visit 2)Population: Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5
Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits. Active participatory communication behaviors include four essential elements: 1. telling a medical history; 2. asking questions; 3. being assertive or making requests, and 4. communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.
Outcome measures
| Measure |
Intervention
n=64 Participants
Patients randomized to the intervention view the intervention video.
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.
|
Control
n=83 Participants
Patients randomized to control view an informative video about diet and nutrition of similar length.
Control: Attention control
|
|---|---|---|
|
Patients Active Participatory Communication Behaviors
Visit 1
|
41.96 utterances
Standard Deviation 25.89
|
44.32 utterances
Standard Deviation 29.25
|
|
Patients Active Participatory Communication Behaviors
Visit 2
|
43.02 utterances
Standard Deviation 30.95
|
42.92 utterances
Standard Deviation 26.52
|
SECONDARY outcome
Timeframe: Four weeks post-intervention (i.e. four weeks after Visit 2).Population: Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal to 7.5
Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale. 1. The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence. 2. The Morisky scale (4-item version) assesses self-reported medication adherence using "yes" or "no" questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence.
Outcome measures
| Measure |
Intervention
n=64 Participants
Patients randomized to the intervention view the intervention video.
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.
|
Control
n=83 Participants
Patients randomized to control view an informative video about diet and nutrition of similar length.
Control: Attention control
|
|---|---|---|
|
Medication Adherence
Measure of Outcome study
|
82.66 units on a scale
Standard Deviation 14.31
|
78.78 units on a scale
Standard Deviation 18.80
|
|
Medication Adherence
Morisky scale
|
3.26 units on a scale
Standard Deviation 1.03
|
3.23 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2.Population: Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5
Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5.
Outcome measures
| Measure |
Intervention
n=64 Participants
Patients randomized to the intervention view the intervention video.
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.
|
Control
n=83 Participants
Patients randomized to control view an informative video about diet and nutrition of similar length.
Control: Attention control
|
|---|---|---|
|
Hemoglobin A1c
baseline
|
10.07 percent
Standard Deviation 1.93
|
9.53 percent
Standard Deviation 1.31
|
|
Hemoglobin A1c
post-visit 2
|
9.07 percent
Standard Deviation 1.68
|
9.27 percent
Standard Deviation 1.73
|
Adverse Events
Intervention
Control
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