Diabetes Mellitus
Conditions
Keywords
Community Health Worker, Financial Incentives
Brief summary
This randomized controlled trial tests how digital health monitoring with financial incentives (DFI) and community health worker (CHW) support may affect how a person manages their diabetes. Participants will be randomized to one of three arms: 1) DFI intervention, 2) hybrid DFI/CHW intervention, or 3) usual care. Investigators hypothesize that compared to usual care and DFI alone, the hybrid intervention will lead to more glucose self-monitoring and greater improvements in glycosylated hemoglobin.
Detailed description
Low-income Americans struggle to stay healthy in the face of real-life challenges such as housing insecurity or trauma. Two interventions show promise for promoting behavior change and improving health outcomes: digital health interventions coupled with financial incentives (DFI) and community health workers (CHWs). Yet, these interventions have limitations; DFI interventions have low uptake and high attrition among vulnerable populations, while CHW interventions are relatively resource intensive. Investigators propose a 24-week randomized trial of a hybrid DFI/CHW intervention among a population of 150 low-income patients with diabetes. Participants will be randomized to one of three arms: 1) DFI intervention, 2) hybrid DFI/CHW intervention, 3) usual care. Participants assigned to DFI will receive a free wireless glucometer and be eligible for a lottery incentive if they use their glucometer. Participants assigned to the hybrid DFI/CHW intervention will receive the same glucometer and incentives. If they exhibit low adherence to self-monitoring or poor glucose control, they will also receive support from a CHW who would help patients to address underlying socioeconomic barriers and cope with setbacks. Investigators hypothesize that compared to usual care and DFI alone, the hybrid intervention will lead to more glucose self-monitoring and greater improvements in glycosylated hemoglobin.
Interventions
BEHAVIORALIMPaCT Community Health Worker
Once a CHW receives notification of a struggling patient, the CHW will visit the patient at their home within 1-2 days to initiate the IMPaCT intervention. 1. Elements of the standard IMPaCT intervention: During the first home visit, the CHW will use an in-depth semi-structured interview guide to get to know patients holistically and assess for unmet socioeconomic needs. This allows patients to express goals in line with their own needs and preferences. These individualized goals will become the basis for tailored action plans. The CHW will then provide hands-on, tailored support for the remainder of the 24-week study period to help patients achieve their goals. 2. Additional elements to help patients cope with failure: In this study, we will test a refined version of IMPaCT that incorporates two behavioral techniques for coping with failure: positive affect induction and attribution retraining.
BEHAVIORALDigital health monitoring with financial incentives
Participants are encouraged to use their glucometer to check their blood glucose via bidirectional texting and lottery-based financial incentives, which both serve to reinforce self-monitoring behavior.
OTHERUsual Care
Usual Care
Sponsors
The Commonwealth Fund
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Penn Medicine patients diagnosed with diabetes mellitus. * Glycosylated hemoglobin \>=9% within the past 6 months. * Requires insulin. * Uninsured/publicly insured. * Residents of high-poverty ZIP codes in West/Southwest Philadelphia. * Have access to a cellphone with unlimited text message capabilities.
Exclusion criteria
* Already have a continuous glucose monitor. * Previously enrolled in the study. * Currently have an outpatient CHW. * Unwilling/unable to provide informed consent. * In another study that asks participants to monitor their blood sugar.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Self-monitoring Adherence | 3 months | constructed by summing the number of days in the study period that the glucometer was used divided by the total number of days in study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin | 6 months | Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants randomized to the usual-care arm were asked to check their daily blood glucose and to continue with their usual care. | 50 |
| Digital Health Participants randomized to the digital health arm were asked to check their blood glucose and text the value daily to a phone number linked to the Way to Health platform. To promote early motivation and habit formation, participants were entered into a lottery each day they texted their glucose values for the first 6 weeks of the study period. Each day participants texted, the lottery provided an 18 in 100 chance of winning $5 and 1 in 100 chance of winning $50. Accrued money was distributed to participants biweekly on a reloadable card.
If participants texted in a blood glucose value that was pre-established as medically dangerous (\< 60, \> 400), they received an automated text encouraging them to follow up with their provider. These values were also routed directly to the study clinician who called each patient within 24 hours to provide clinical management and coordinate care with the patient's provider. | 50 |
| Hybrid Digital Health and Community Health Worker Support Participants in the hybrid arm received all aspects of the digital health intervention. Additionally, CHWs met with participants at enrollment and provided brief coaching using positive affect induction and attribution retraining to increase resilience to setbacks. At this meeting, CHWs explained to patients that they might work with them in the future if they needed additional support. During the first 12 weeks of the study, hybrid arm participants with low rates of SMBG (defined as 5 instances of missed readings) and/or elevated glucose readings (defined as a glucose level \> 300 mg/dL for \> 30% of days over any 2-week period) were 'escalated' to receive intensive CHW support.
CHWs implemented the IMPaCT intervention, in which the CHW used an in-depth semi-structured interview guide to get to know participants' strengths, goals, and unmet social needs. Participants' individualized goals became the basis for tailored action plans. For the remainder of the 24-week study period, CHWs provided coaching, social support, advocacy, and navigation to support participants in achieving their health goals. CHWs communicated with participants at least once per week, including monthly face-to-face contact. CHWs normalized setbacks and used positive affect induction and attribution retraining to help patients to cope with failure. CHWs also helped participants connect to long-term family and social supports after the intervention ended. | 50 |
| Total | 150 |
Baseline characteristics
| Characteristic | Total | Hybrid Digital Health and Community Health Worker Support | Digital Health | Usual Care |
|---|---|---|---|---|
| Adverse childhood experiences | 3.0 units on a scale STANDARD_DEVIATION 2.6 | 2.8 units on a scale STANDARD_DEVIATION 2.4 | 3.3 units on a scale STANDARD_DEVIATION 2.6 | 3.1 units on a scale STANDARD_DEVIATION 2.8 |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 12 | 54.1 years STANDARD_DEVIATION 12.8 | 55.0 years STANDARD_DEVIATION 14.1 | 56.3 years STANDARD_DEVIATION 8.7 |
| Alcohol overuse | 28 Participants | 7 Participants | 10 Participants | 11 Participants |
| Drug use | 19 Participants | 5 Participants | 6 Participants | 8 Participants |
| Employed | 18 Participants | 2 Participants | 7 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 3 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 141 Participants | 47 Participants | 46 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| HbA1C | 10.96 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.94 | 10.89 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.01 | 11.05 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.58 | 10.94 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.21 |
| Health literacy | 1.9 units on a scale STANDARD_DEVIATION 1.2 | 2.1 units on a scale STANDARD_DEVIATION 1.3 | 1.8 units on a scale STANDARD_DEVIATION 1.2 | 1.9 units on a scale STANDARD_DEVIATION 1.1 |
| Highest level of education College graduate | 14 Participants | 5 Participants | 5 Participants | 4 Participants |
| Highest level of education HS or GED | 58 Participants | 20 Participants | 22 Participants | 16 Participants |
| Highest level of education Less than HS | 36 Participants | 11 Participants | 10 Participants | 15 Participants |
| Highest level of education Some college/technical school | 42 Participants | 14 Participants | 13 Participants | 15 Participants |
| Household income <15K | 94 Participants | 32 Participants | 30 Participants | 32 Participants |
| Household income >=15K | 51 Participants | 17 Participants | 18 Participants | 16 Participants |
| Household income Unknown | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Insurance Medicaid | 87 Participants | 33 Participants | 27 Participants | 27 Participants |
| Insurance Medicaid/Medicare | 61 Participants | 16 Participants | 22 Participants | 23 Participants |
| Insurance Other | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Insurance Uninsured | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Low social support | 18 Participants | 7 Participants | 7 Participants | 4 Participants |
| More than 1 competing need | 57 Participants | 20 Participants | 23 Participants | 14 Participants |
| Patient Activation Measure | 67.6 units on a scale STANDARD_DEVIATION 15.4 | 65.8 units on a scale STANDARD_DEVIATION 14.2 | 67.3 units on a scale STANDARD_DEVIATION 15.4 | 69.5 units on a scale STANDARD_DEVIATION 16.6 |
| Perceived stress | 5.9 units on a scale STANDARD_DEVIATION 3.7 | 5.7 units on a scale STANDARD_DEVIATION 3.6 | 6.1 units on a scale STANDARD_DEVIATION 4 | 5.9 units on a scale STANDARD_DEVIATION 3.5 |
| Postponed needed medical care | 27 Participants | 11 Participants | 9 Participants | 7 Participants |
| Prior healthcare utilization, past 6 months (self-report) Any ED visit | 82 Participants | 30 Participants | 29 Participants | 23 Participants |
| Prior healthcare utilization, past 6 months (self-report) Any hospital admission | 53 Participants | 14 Participants | 20 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 126 Participants | 42 Participants | 39 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 1 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 105 Participants | 35 Participants | 36 Participants | 34 Participants |
| Sex: Female, Male Male | 44 Participants | 15 Participants | 14 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 13 / 50 | 13 / 50 | 14 / 50 |
Outcome results
Primary
Glucose Self-monitoring Adherence
constructed by summing the number of days in the study period that the glucometer was used divided by the total number of days in study period
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Glucose Self-monitoring Adherence | 65 percentage of days | Standard Deviation 28 |
| Digital Health | Glucose Self-monitoring Adherence | 70 percentage of days | Standard Deviation 25 |
| Hybrid Digital Health and Community Health Worker Support | Glucose Self-monitoring Adherence | 72 percentage of days | Standard Deviation 29 |
Other Pre-specified
Change in Glycosylated Hemoglobin
Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Glycosylated Hemoglobin | -0.49 percentage of glycosylated hemoglobin | Standard Deviation 1.75 |
| Digital Health | Change in Glycosylated Hemoglobin | -0.85 percentage of glycosylated hemoglobin | Standard Deviation 1.9 |
| Hybrid Digital Health and Community Health Worker Support | Change in Glycosylated Hemoglobin | -0.74 percentage of glycosylated hemoglobin | Standard Deviation 1.66 |