Type 2 Diabetes
Conditions
Brief summary
Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. This highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.
Detailed description
To address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. The American Geriatrics Society (AGS) and the American Diabetes Association (ADA) have published recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) \<7.5%, \<8.0%, or \<8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. Despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. Interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources. Investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in personalized goal setting and chronic disease management.
Interventions
BEHAVIORALMy Diabetes Goal
Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
BEHAVIORALMy Diabetes Goal + CommunityRx
Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource prescriptions) for community organizations.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
This will be a single-blind study, and subjects will blinded to the different group assignment.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. History of type 2 diabetes 2. Seen in clinic within past year 3. A1C\>7.5% 4. Community dwelling 5. Access to personal email address OR internet access 6. Speaks and reads English 7. Resides in the target geographic region (zip codes)
Exclusion criteria
1. Unable to consent to study for themselves 2. Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Percent of Hemoglobin A1C | Baseline to 12 months | Mean change in percent of hemoglobin A1C from baseline to month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 | Baseline to 12 months | We reviewed the electronic health records (EHR) to assess how many participants had a documented goal in the EHR at baseline and at 12 months. The possible values will be yes or no goals documented in the EHR. |
| Personalized A1C Goals | Baseline to Month 1 Call | The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. Goal setting conversation with nurse occurred during Month 1 call. |
| Number of Participants Who Achieved Personalized A1C Goals | Baseline to 12 months | Investigators will measure whether or not patients are reaching the modified goals they have documented in the survey, among those who have set up their personalized goals. The possible values will be yes or no reaching personalized goals. |
| Diabetes Empowerment Scale (DES) | Baseline to 12 months | Evaluate subject self-efficacy through the Diabetes Empowerment Scale (DES). DES is a standardized questionnaire including 28 questions with response categories of 'strongly disagree', 'somewhat disagree', 'neutral', 'somewhat agree', and 'strongly agree'. A total score for the DES is calculated by summing all of the item scores and dividing by 28 for a possible score range of 1-5 where a higher score indicates a higher level of empowerment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Attention Control Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control) | 167 |
| My Diabetes Goal My Diabetes Goal protocol
My Diabetes Goal: Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. | 173 |
| My Diabetes Goal + Community Rx My Diabetes Goal protocol + Community Rx protocol
My Diabetes Goal + CommunityRx: Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource prescriptions) for community organizations. | 165 |
| Total | 505 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | deemed ineligible after randomization | 3 | 0 | 4 |
Baseline characteristics
| Characteristic | Attention Control | My Diabetes Goal | My Diabetes Goal + Community Rx | Total |
|---|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 6.3 | 68.8 years STANDARD_DEVIATION 5.9 | 69.2 years STANDARD_DEVIATION 6.7 | 69.0 years STANDARD_DEVIATION 6.3 |
| Diabetes Empowerment Scale (DES) | 4.2 units on a scale STANDARD_DEVIATION 0.6 | 4.3 units on a scale STANDARD_DEVIATION 0.5 | 4.1 units on a scale STANDARD_DEVIATION 0.6 | 4.2 units on a scale STANDARD_DEVIATION 0.6 |
| Most Recent A1C Value | 9.0 % (percentage of A1C) STANDARD_DEVIATION 1.5 | 9.1 % (percentage of A1C) STANDARD_DEVIATION 1.6 | 9.0 % (percentage of A1C) STANDARD_DEVIATION 1.5 | 9.0 % (percentage of A1C) STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Black or African American | 123 Participants | 126 Participants | 129 Participants | 378 Participants |
| Race/Ethnicity, Customized Other | 16 Participants | 14 Participants | 11 Participants | 41 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 33 Participants | 25 Participants | 86 Participants |
| Region of Enrollment United States | 167 participants | 173 participants | 165 participants | 505 participants |
| Sex: Female, Male Female | 105 Participants | 114 Participants | 113 Participants | 332 Participants |
| Sex: Female, Male Male | 62 Participants | 59 Participants | 52 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 167 | 3 / 173 | 4 / 165 |
| other Total, other adverse events | 0 / 167 | 0 / 173 | 0 / 165 |
| serious Total, serious adverse events | 0 / 167 | 0 / 173 | 0 / 165 |
Outcome results
Primary
Mean Change in Percent of Hemoglobin A1C
Mean change in percent of hemoglobin A1C from baseline to month 12.
Time frame: Baseline to 12 months
Population: There are missing 12 month A1C values for all three study arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Mean Change in Percent of Hemoglobin A1C | -1.1 percentage of hemoglobin A1C | Standard Deviation 1.79 |
| My Diabetes Goal | Mean Change in Percent of Hemoglobin A1C | -0.8 percentage of hemoglobin A1C | Standard Deviation 2.1 |
| My Diabetes Goal + Community Rx | Mean Change in Percent of Hemoglobin A1C | -0.8 percentage of hemoglobin A1C | Standard Deviation 1.5 |
p-value: 0.8Mixed Models Analysis
p-value: 0.3Mixed Models Analysis
p-value: 0.5Mixed Models Analysis
Secondary
Diabetes Empowerment Scale (DES)
Evaluate subject self-efficacy through the Diabetes Empowerment Scale (DES). DES is a standardized questionnaire including 28 questions with response categories of 'strongly disagree', 'somewhat disagree', 'neutral', 'somewhat agree', and 'strongly agree'. A total score for the DES is calculated by summing all of the item scores and dividing by 28 for a possible score range of 1-5 where a higher score indicates a higher level of empowerment.
Time frame: Baseline to 12 months
Population: Number analyzed is dependent on survey respondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Diabetes Empowerment Scale (DES) | -0.1 score on a scale | Standard Deviation 1 |
| My Diabetes Goal | Diabetes Empowerment Scale (DES) | -0.2 score on a scale | Standard Deviation 1.2 |
| My Diabetes Goal + Community Rx | Diabetes Empowerment Scale (DES) | 0.03 score on a scale | Standard Deviation 1.1 |
p-value: 0.9Mixed Models Analysis
p-value: 0.2Mixed Models Analysis
p-value: 0.1Mixed Models Analysis
Secondary
Number of Participants Who Achieved Personalized A1C Goals
Investigators will measure whether or not patients are reaching the modified goals they have documented in the survey, among those who have set up their personalized goals. The possible values will be yes or no reaching personalized goals.
Time frame: Baseline to 12 months
Population: The number of analyzed A1C goal results is dependent on the number of survey respondents in the two intervention arms. The Attention Control arm did not include a goal setting exercise.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Attention Control | Number of Participants Who Achieved Personalized A1C Goals | Achieved Goal at Baseline | 5 Participants |
| Attention Control | Number of Participants Who Achieved Personalized A1C Goals | Achieved Goal at 12 Months | 38 Participants |
| My Diabetes Goal | Number of Participants Who Achieved Personalized A1C Goals | Achieved Goal at Baseline | 1 Participants |
| My Diabetes Goal | Number of Participants Who Achieved Personalized A1C Goals | Achieved Goal at 12 Months | 34 Participants |
Comparison: Achieved goal at baseline across three arms.p-value: 0.2Chi-squared
Comparison: Achieved goal at 12 months across all three arms.p-value: 0.9Chi-squared
Secondary
Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12
We reviewed the electronic health records (EHR) to assess how many participants had a documented goal in the EHR at baseline and at 12 months. The possible values will be yes or no goals documented in the EHR.
Time frame: Baseline to 12 months
Population: The number of analyzed A1C goal results is dependent on the number of survey respondents.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Attention Control | Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 | Documented Goals at Baseline | 52 Participants |
| Attention Control | Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 | Documented Goals After Baseline | 43 Participants |
| My Diabetes Goal | Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 | Documented Goals at Baseline | 60 Participants |
| My Diabetes Goal | Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 | Documented Goals After Baseline | 165 Participants |
| My Diabetes Goal + Community Rx | Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 | Documented Goals at Baseline | 43 Participants |
| My Diabetes Goal + Community Rx | Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12 | Documented Goals After Baseline | 156 Participants |
Comparison: Documented goals at baseline for all three arms.p-value: 0.2Chi-squared
Comparison: Documented goals after Baseline in all three arms.p-value: <0.001Chi-squared
Secondary
Personalized A1C Goals
The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. Goal setting conversation with nurse occurred during Month 1 call.
Time frame: Baseline to Month 1 Call
Population: The number of analyzed A1C goal results is dependent on the number of survey respondents in the two intervention arms. The Attention Control arm did not include a goal setting conversation with a nurse.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Personalized A1C Goals | Initial Goal | 6.6 % (percentage A1c) | Standard Deviation 0.9 |
| Attention Control | Personalized A1C Goals | Modified Goal | 7.1 % (percentage A1c) | Standard Deviation 0.8 |
| My Diabetes Goal | Personalized A1C Goals | Initial Goal | 6.7 % (percentage A1c) | Standard Deviation 0.7 |
| My Diabetes Goal | Personalized A1C Goals | Modified Goal | 7.1 % (percentage A1c) | Standard Deviation 0.7 |
Comparison: Initial goal at baseline.p-value: 0.7Chi-squared
Comparison: Modified goal after Month 1 call with nurse.p-value: 0.6Chi-squared