DiabetesNCT03950973
Diabetes Outcomes and Unmet Resources
A study testing CareAvenue and Guest Assistance Program in people with Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- CareAvenue and Guest Assistance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2019to 28 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18-75 years of age
- Be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication
- Have a most recent hemoglobin A1c(HbA1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and >8.0% for individuals between 70-75 years in age
- Have access to a telephone that can receive and send text messages
- Not participating in another diabetes intervention research study
Who cannot join
- Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs
This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.
- Conditions
- Diabetes
- Being tested
- CareAvenue, Guest Assistance Program
- Keywords
- Diabetes, Self-management, Adherence, Social determinants of health, Social risk factors
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareAvenueBehavioural
CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
Guest Assistance ProgramBehavioural
The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
| Study group | Role | What they receive |
|---|---|---|
| CareAvenue | Experimental | Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks. Receives: Behavioral: CareAvenue |
| Guest Assistance Program | Active comparator | Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. Receives: Behavioral: Guest Assistance Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c as Measured by an HbA1c Machine
HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage.
The change in HbA1c from baseline to 12 months is reported here as the primary outcome.
Measured: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Secondary outcomes (6)
Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine
Systolic blood pressure will be measured at baseline, 6 months, and 12 months using an automated blood pressure machine in millimeters of mercury (e.g., 120 mm Hg).
The change in systolic blood pressure from baseline to 12 months is reported here as secondary outcome.
Measured: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire
Cost-Related Non-Adherence (CRN) Behaviors related to diabetes will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at diabetes. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Min value of 0, max value of 18, with higher scores indicating more cost-related non-adherence behaviors.
The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome.
Measured: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire
Cost-Related Non-Adherence (CRN) Behaviors related to other conditions being managed will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at other health conditions being managed. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Mean values were obtained, with min value of 0, max value of 1, with higher mean scores indicating more cost-related non-adherence behaviors.
The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome.
Measured: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)
Perceived Financial Burden will be measured at baseline, 6 months, and 12 months by the 11-item measure Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) that were measured on a 5-point scale (0: not at all - 4: very much). The score includes reverse-coding 6-items, summing all items, multiplying sum by 11 and dividing the total by number of items answered. Lower scores indicate higher perceptions of financial burden. (Min value of 0, max value of 44) The change in perceived financial burden (COST measure) from baseline to 12 months is reported here as secondary outcome.
Measured: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire
Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 20 items adapted from the Accountable Health Communities Health-Related Social Needs Screening Tool, the Health Leads Social Needs Screening Toolkit, and the Kaiser Permanente Your Current Life Situation Questionnaire. The item values are binary (yes/no). Higher number of "yes" responses indicates higher number of unmet social risk factors/higher need. (Min value of 0, max value of 20).
The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome.
Measured: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Unmet Social Risk Factors as Measured by Participant Questionnaire
Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 3 items from the Accountable Health Communities Health-Related Social Needs Screening Tool and 1 item adapted from the National Health Interview Survey. The items each have three response options, in which a positive response indicates an unmet social risk factor. Higher scores indicate more unmet social risk factors (min value of 0; max value of 8).
The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome.
Measured: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start26 Jun 2019
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minal Patel, University of Michigan
- Investigators
- Minal R Patel, PhD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950973
- Sponsor's protocol ID
- HUM00149794
- Other IDs
- R01DK116715
- Status last verified
- Apr 2024
- First submitted
- 13 May 2019
- Last updated
- 2 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data that underlie results in a publication, after de-identification.
Publications
Patel MR, Zhang G, Heisler M, Piette JD, Resnicow K, Choe HM, Shi X, Song P. A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes. J Gen Intern Med. 2024 Oct;39(13):2415-2424. doi: 10.1007/s11606-024-08708-8. Epub 2024 Mar 11.
PubMed 38467918Patel MR, Heisler M, Piette JD, Resnicow K, Song PXK, Choe HM, Shi X, Tobi J, Smith A. Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial. Contemp Clin Trials. 2020 Feb;89:105933. doi: 10.1016/j.cct.2020.105933. Epub 2020 Jan 7.
PubMed 31923472
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs
- ClinicalTrials.gov ID
- NCT03950973
- Acronym / sponsor ID
- HUM00149794
- Conditions
- Diabetes
- Keywords
- Diabetes, Self-management, Adherence, Social determinants of health, Social risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CareAvenue | Experimental | Behavioral: CareAvenueParticipants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks. |
| Guest Assistance Program | Active comparator | Behavioral: Guest Assistance ProgramParticipants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18-75 years of age
- Be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication
- Have a most recent hemoglobin A1c(HbA1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and >8.0% for individuals between 70-75 years in age
- Have access to a telephone that can receive and send text messages
- Not participating in another diabetes intervention research study
Key exclusion criteria (1 listed)
- Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareAvenueCareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management. | Behavioural | CareAvenue |
| Guest Assistance ProgramThe Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management. | Behavioural | Guest Assistance Program |
Primary outcome
Change in HbA1c as Measured by an HbA1c Machine
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage. The change in HbA1c from baseline to 12 months is reported here as the primary outcome.
6 secondary outcomes
Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Change in Unmet Social Risk Factors as Measured by Participant Questionnaire
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38467918Patel MR, Zhang G, Heisler M, Piette JD, Resnicow K, Choe HM, Shi X, Song P. A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes. J Gen Intern Med. 2024 Oct;39(13):2415-2424. doi: 10.1007/s11606-024-08708-8. Epub 2024 Mar 11.
- Derived from this study: PubMed 31923472Patel MR, Heisler M, Piette JD, Resnicow K, Song PXK, Choe HM, Shi X, Tobi J, Smith A. Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial. Contemp Clin Trials. 2020 Feb;89:105933. doi: 10.1016/j.cct.2020.105933. Epub 2020 Jan 7.
- Individual participant dataSharing planned: Yes. All of the individual participant data that underlie results in a publication, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minal R Patel, PhD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareAvenue and Guest Assistance Program in people with Diabetes, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c as Measured by an HbA1c Machine (time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.