Diabetes Outcomes and Unmet Resources

Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03950973

Enrollment

667

Registered

2019-05-15

Start date

2019-06-26

Completion date

2023-03-28

Last updated

2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Self-management, Adherence, Social determinants of health, Social risk factors

Brief 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. 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.

Interventions

BEHAVIORALCareAvenue

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.

BEHAVIORALGuest Assistance Program

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.

Design outcomes

Primary

Measure	Time frame	Description
Change in HbA1c as Measured by an HbA1c Machine	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.

Secondary

Measure	Time frame	Description
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.
Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.
Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.
Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.
Change in Unmet Social Risk Factors as Measured by Participant Questionnaire	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.
Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.

Countries

United States

Participant flow

Pre-assignment details

After screening eligible and consenting to participate, 67 participants either later changed their mind and declined to participate prior to starting data collection, were unreachable for baseline collection, or did not complete baseline in order to be randomized.

Participants by arm

Arm	Count
CareAvenue (Intervention) 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. CareAvenue: 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.	301
Guest Assistance Program (Control) 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. Guest Assistance Program: 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.	299
Total	600

Baseline characteristics

Characteristic	CareAvenue (Intervention)	Total	Guest Assistance Program (Control)
Age, Continuous	52.64 years STANDARD_DEVIATION 13.68	53.45 years STANDARD_DEVIATION 1304	54.26 years STANDARD_DEVIATION 12.33
Health Insurance Type Medicaid	45 Participants	79 Participants	34 Participants
Health Insurance Type Medicare	19 Participants	44 Participants	25 Participants
Health Insurance Type Medicare + Medicaid Supplemental	34 Participants	64 Participants	30 Participants
Health Insurance Type Medicare + Private Supplemental	68 Participants	140 Participants	72 Participants
Health Insurance Type None	2 Participants	11 Participants	9 Participants
Health Insurance Type Other	1 Participants	2 Participants	1 Participants
Health Insurance Type Private	132 Participants	260 Participants	128 Participants
Income as percent of poverty level 100-200%	52 Participants	95 Participants	43 Participants
Income as percent of poverty level 201-400%	131 Participants	261 Participants	130 Participants
Income as percent of poverty level Greater than 400%	79 Participants	164 Participants	85 Participants
Income as percent of poverty level Less than 100%	35 Participants	73 Participants	38 Participants
Number of chronic conditions	4.12 number of chronic conditions STANDARD_DEVIATION 2.31	4.15 number of chronic conditions STANDARD_DEVIATION 2.31	4.18 number of chronic conditions STANDARD_DEVIATION 2.31
Race/Ethnicity, Customized Race Asian	9 Participants	23 Participants	14 Participants
Race/Ethnicity, Customized Race Hispanic	16 Participants	31 Participants	15 Participants
Race/Ethnicity, Customized Race Multiple Race	22 Participants	42 Participants	20 Participants
Race/Ethnicity, Customized Race Non-Hispanic Black	43 Participants	101 Participants	58 Participants
Race/Ethnicity, Customized Race Non-Hispanic White	204 Participants	388 Participants	184 Participants
Race/Ethnicity, Customized Race Other	6 Participants	13 Participants	7 Participants
Region of Enrollment United States	301 Participants	600 Participants	299 Participants
Sex/Gender, Customized Gender Female	168 Participants	334 Participants	166 Participants
Sex/Gender, Customized Gender Male	132 Participants	264 Participants	132 Participants
Sex/Gender, Customized Gender Other	1 Participants	2 Participants	1 Participants
Type of diabetes Type 1	61 Participants	130 Participants	69 Participants
Type of diabetes Type 2	240 Participants	470 Participants	230 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 301	2 / 299
other Total, other adverse events	75 / 301	86 / 299
serious Total, serious adverse events	123 / 301	125 / 299

Outcome results

Primary

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.