Type2 Diabetes
Conditions
Brief summary
This study will integrate a technology-based patient-reported outcome (PRO) system \[herein MJS DIABETES\] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platform that utilizes text-messaging to capture patients' self-reported PROs in real-time; enhance patient engagement through data-driven feedback and motivational messages; and create dynamic visualizations of the PROs that can be shared in printed reports, and integrated into the EHR; thus making it actionable for patients and their PCPs. Using a mixed-methods design, this study will be conducted in 2 phases: 1) a formative phase, using the evidence-based user-centered design approach; and 2) a clinical-efficacy phase. For the formative phase, a qualitative research method will be used to: a) adapt MJS to the needs of PCPs and T2D patients; b) integrate MJS DIABETES into the EHR system, the primary care practice and the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and their PCPs in order to optimize the tool's performance and workflow integration. For the clinical efficacy phase, a randomized control trial will be used to identify the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices.
Interventions
BEHAVIORALMJS Diabetes
patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Primary Care Provider Inclusion Criteria: * Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers (FHCs) and, * Provide care to at least five patients with a diagnosis of T2D. Patient Inclusion Criteria: * Have a diagnosis of T2D for ≥6 months; * Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year; * Fluency in English or Spanish; * Be willing to send/receive text messages; and
Exclusion criteria
* Have a diagnosis of T2D for ≥6 months; * Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year; * Fluency in English or Spanish; * Be willing to send/receive text messages; and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Level at Baseline | Baseline | Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation. |
| HbA1c Level at Month 12 | Month 12 | Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | Baseline | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. |
| Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | Baseline | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. |
| Michigan Diabetes Knowledge Scale Score | Baseline | 20-item assessment of diabetes knowledge. Each item has a potential response of True, False, and I don't know. The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge. |
| Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | Baseline | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. |
| Interpersonal Processes of Care Score Communication Subscale Score | Baseline | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). |
| Interpersonal Processes of Care: Decision Making Subscale Score | Baseline | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). |
| Interpersonal Processes of Care: Inter-personal Style Subscale Score | Baseline | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). |
| Diabetes Self-Efficacy Scale Score | Baseline | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. |
| Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | Baseline | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. |
Countries
United States
Participant flow
Pre-assignment details
N= 246 participants were enrolled, N=9 of these participants were not randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| MJS DIABETES MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs. | 109 |
| Usual Care Standard Diabetes Treatment | 114 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 |
| Overall Study | New diagnosis | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | MJS DIABETES | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 9.54 | 56.1 years STANDARD_DEVIATION 9.41 | 55.7 years STANDARD_DEVIATION 9.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 39 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 184 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 75 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 55 Participants | 30 Participants |
| Race (NIH/OMB) White | 42 Participants | 80 Participants | 38 Participants |
| Region of Enrollment United States | 109 participants | 223 participants | 114 participants |
| Sex: Female, Male Female | 67 Participants | 133 Participants | 66 Participants |
| Sex: Female, Male Male | 42 Participants | 90 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 117 | 0 / 120 |
| other Total, other adverse events | 0 / 117 | 0 / 120 |
| serious Total, serious adverse events | 0 / 117 | 0 / 120 |
Outcome results
Primary
HbA1c Level at Baseline
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MJS DIABETES | HbA1c Level at Baseline | 8.37 Percentage of total hemoglobin |
| Usual Care | HbA1c Level at Baseline | 8.29 Percentage of total hemoglobin |
Primary
HbA1c Level at Month 12
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
Time frame: Month 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MJS DIABETES | HbA1c Level at Month 12 | 8.02 Percentage of total hemoglobin |
| Usual Care | HbA1c Level at Month 12 | 8.15 Percentage of total hemoglobin |
Secondary
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Diabetes Self-Efficacy Scale Score | 7.38 score on a scale | Standard Deviation 1.86 |
| Usual Care | Diabetes Self-Efficacy Scale Score | 7.42 score on a scale | Standard Deviation 1.91 |
Secondary
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Diabetes Self-Efficacy Scale Score | 8.16 score on a scale | Standard Deviation 1.48 |
| Usual Care | Diabetes Self-Efficacy Scale Score | 7.8 score on a scale | Standard Deviation 1.78 |
Secondary
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Diabetes Self-Efficacy Scale Score | 7.96 score on a scale | Standard Deviation 1.58 |
| Usual Care | Diabetes Self-Efficacy Scale Score | 7.49 score on a scale | Standard Deviation 2.07 |
Secondary
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Diabetes Self-Efficacy Scale Score | 8.09 score on a scale | Standard Deviation 1.62 |
| Usual Care | Diabetes Self-Efficacy Scale Score | 7.81 score on a scale | Standard Deviation 1.84 |
Secondary
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Diabetes Self-Efficacy Scale Score | 7.64 score on a scale | Standard Deviation 1.85 |
| Usual Care | Diabetes Self-Efficacy Scale Score | 7.65 score on a scale | Standard Deviation 1.86 |
Secondary
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Decision Making Subscale Score | 3.93 score on a scale | Standard Deviation 1.06 |
| Usual Care | Interpersonal Processes of Care: Decision Making Subscale Score | 4.09 score on a scale | Standard Deviation 1.02 |
Secondary
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Decision Making Subscale Score | 3.93 score on a scale | Standard Deviation 1.06 |
| Usual Care | Interpersonal Processes of Care: Decision Making Subscale Score | 4.09 score on a scale | Standard Deviation 1.02 |
Secondary
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Decision Making Subscale Score | 3.93 score on a scale | Standard Deviation 1.12 |
| Usual Care | Interpersonal Processes of Care: Decision Making Subscale Score | 3.98 score on a scale | Standard Deviation 1.05 |
Secondary
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Decision Making Subscale Score | 3.86 score on a scale | Standard Deviation 1.01 |
| Usual Care | Interpersonal Processes of Care: Decision Making Subscale Score | 3.97 score on a scale | Standard Deviation 1.05 |
Secondary
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Decision Making Subscale Score | 3.74 score on a scale | Standard Deviation 1.12 |
| Usual Care | Interpersonal Processes of Care: Decision Making Subscale Score | 3.71 score on a scale | Standard Deviation 1.14 |
Secondary
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.48 score on a scale | Standard Deviation 0.63 |
| Usual Care | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.6 score on a scale | Standard Deviation 0.51 |
Secondary
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.47 score on a scale | Standard Deviation 0.65 |
| Usual Care | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.6 score on a scale | Standard Deviation 0.63 |
Secondary
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.47 score on a scale | Standard Deviation 0.65 |
| Usual Care | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.6 score on a scale | Standard Deviation 0.63 |
Secondary
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.52 score on a scale | Standard Deviation 0.56 |
| Usual Care | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.61 score on a scale | Standard Deviation 0.62 |
Secondary
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.53 score on a scale | Standard Deviation 0.58 |
| Usual Care | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 4.67 score on a scale | Standard Deviation 0.5 |
Secondary
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care Score Communication Subscale Score | 4.36 score on a scale | Standard Deviation 0.7 |
| Usual Care | Interpersonal Processes of Care Score Communication Subscale Score | 4.45 score on a scale | Standard Deviation 0.55 |
Secondary
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care Score Communication Subscale Score | 4.4 score on a scale | Standard Deviation 0.61 |
| Usual Care | Interpersonal Processes of Care Score Communication Subscale Score | 4.49 score on a scale | Standard Deviation 0.56 |
Secondary
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care Score Communication Subscale Score | 4.31 score on a scale | Standard Deviation 0.66 |
| Usual Care | Interpersonal Processes of Care Score Communication Subscale Score | 4.4 score on a scale | Standard Deviation 0.67 |
Secondary
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care Score Communication Subscale Score | 4.36 score on a scale | Standard Deviation 0.64 |
| Usual Care | Interpersonal Processes of Care Score Communication Subscale Score | 4.47 score on a scale | Standard Deviation 0.58 |
Secondary
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Interpersonal Processes of Care Score Communication Subscale Score | 4.28 score on a scale | Standard Deviation 0.71 |
| Usual Care | Interpersonal Processes of Care Score Communication Subscale Score | 4.34 score on a scale | Standard Deviation 0.61 |
Secondary
Michigan Diabetes Knowledge Scale Score
20-item assessment of diabetes knowledge. Each item has a potential response of True, False, and I don't know. The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Michigan Diabetes Knowledge Scale Score | 0.66 score on a scale | Standard Deviation 0.17 |
| Usual Care | Michigan Diabetes Knowledge Scale Score | 0.65 score on a scale | Standard Deviation 0.14 |
Secondary
Michigan Diabetes Knowledge Scale Score
20-item assessment of diabetes knowledge. Each item has a potential response of True, False, and I don't know. The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Michigan Diabetes Knowledge Scale Score | 0.68 score on a scale | Standard Deviation 0.16 |
| Usual Care | Michigan Diabetes Knowledge Scale Score | 0.64 score on a scale | Standard Deviation 0.15 |
Secondary
Michigan Diabetes Knowledge Scale Score
20-item assessment of diabetes knowledge. Each item has a potential response of True, False, and I don't know. The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Michigan Diabetes Knowledge Scale Score | 0.71 score on a scale | Standard Deviation 0.15 |
| Usual Care | Michigan Diabetes Knowledge Scale Score | 0.66 score on a scale | Standard Deviation 0.16 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 4.43 score on a scale | Standard Deviation 2.71 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 3.98 score on a scale | Standard Deviation 2.89 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 4.24 score on a scale | Standard Deviation 2.8 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 4.04 score on a scale | Standard Deviation 2.87 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 4.32 score on a scale | Standard Deviation 2.8 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 3.95 score on a scale | Standard Deviation 2.92 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 4.4 score on a scale | Standard Deviation 2.79 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 4.07 score on a scale | Standard Deviation 2.76 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 3.74 score on a scale | Standard Deviation 2.78 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | 3.74 score on a scale | Standard Deviation 2.9 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 3.87 score on a scale | Standard Deviation 1.68 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 3.42 score on a scale | Standard Deviation 1.88 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4.31 score on a scale | Standard Deviation 1.64 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4 score on a scale | Standard Deviation 1.84 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4.21 score on a scale | Standard Deviation 1.53 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4.13 score on a scale | Standard Deviation 1.65 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4.47 score on a scale | Standard Deviation 1.48 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4.18 score on a scale | Standard Deviation 1.67 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4.48 score on a scale | Standard Deviation 1.54 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | 4.29 score on a scale | Standard Deviation 1.66 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 3.54 score on a scale | Standard Deviation 2 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 3.01 score on a scale | Standard Deviation 2.06 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 3.62 score on a scale | Standard Deviation 2.09 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 3.26 score on a scale | Standard Deviation 2.16 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 3.68 score on a scale | Standard Deviation 2.1 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 3.1 score on a scale | Standard Deviation 2.07 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 3.56 score on a scale | Standard Deviation 2.22 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 2.98 score on a scale | Standard Deviation 2.32 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 2.93 score on a scale | Standard Deviation 2.02 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | 2.59 score on a scale | Standard Deviation 2.07 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 4.39 score on a scale | Standard Deviation 2.29 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 4 score on a scale | Standard Deviation 2.4 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 3.12 score on a scale | Standard Deviation 2.69 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 3.05 score on a scale | Standard Deviation 2.63 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 3.62 score on a scale | Standard Deviation 2.42 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 3.77 score on a scale | Standard Deviation 2.54 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 4.1 score on a scale | Standard Deviation 2.58 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 3.89 score on a scale | Standard Deviation 2.56 |
Secondary
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities.
Time frame: Month 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MJS DIABETES | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 4.27 score on a scale | Standard Deviation 2.33 |
| Usual Care | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | 3.98 score on a scale | Standard Deviation 2.38 |