Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK127961-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | No Intervention | Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control) | |
| My Diabetes Goal | Active Comparator | My Diabetes Goal protocol |
|
| My Diabetes Goal + Community Rx | Active Comparator | My Diabetes Goal protocol + Community Rx protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Diabetes Goal | Behavioral | Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Percent of Hemoglobin A1C | Mean change in percent of hemoglobin A1C from baseline to month 12. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elbert Huang | University of Chicago | Principal Investigator |
| Stacy Lindau | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36909590 | Derived | Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1. |
Not provided
Not provided
We do not plan to share IPD with other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control | Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control) |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Does not include 7 deemed ineligible after randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control) |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Percent of Hemoglobin A1C | Mean change in percent of hemoglobin A1C from baseline to month 12. | There are missing 12 month A1C values for all three study arms. | Posted | Mean | Standard Deviation | percentage of hemoglobin A1C | Baseline to 12 months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Control | Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Kanoon | University of Chicago | 773-834-3419 | kanoon@bsd.uchicago.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2024 | Oct 29, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2022 | Oct 29, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a single-blind study, and subjects will blinded to the different group assignment.
| My Diabetes Goal + CommunityRx | Behavioral | 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. |
|
| 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. |
| Baseline to Month 1 Call |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Most Recent A1C Value | Mean | Standard Deviation | % (percentage of A1C) |
|
| Diabetes Empowerment Scale (DES) | 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. | Mean | Standard Deviation | units on a scale |
|
| OG002 | 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. |
|
|
|
| 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. | The number of analyzed A1C goal results is dependent on the number of survey respondents. | Posted | Count of Participants | Participants | Baseline to 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | % (percentage A1c) | Baseline to Month 1 Call |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline to 12 months |
|
|
|
|
| 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. | Number analyzed is dependent on survey respondents. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
|
|
|
|
| 1 |
| 167 |
| 0 |
| 167 |
| 0 |
| 167 |
| EG001 | 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. | 3 | 173 | 0 | 173 | 0 | 173 |
| EG002 | 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. | 4 | 165 | 0 | 165 | 0 | 165 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Documented Goals After Baseline |
|
|
| <0.001 |
| Superiority |
| Modified Goal |
|
|
| 0.6 |
| Superiority |
| Achieved Goal at 12 Months |
|
|
| 0.9 |
| Superiority |
| Superiority |
| Mixed Models Analysis | 0.1 | Superiority |