Diabetes Type 2
Conditions
Keywords
self care of diabetes type 2 patients, mobile health cell phone application impact on health, community health workers impact on health
Brief summary
This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.
Detailed description
This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for DM2 Medicaid patients with uncontrolled DM. * Group 1 will be assisted by the Voxiva Care4Life mobile health disease management program (C4L) provided on the patient's cell phone. * Group 2 will be assisted by CHWs who are members of the outpatient medical home health team. * Group 3 will be assisted by both the Voxiva Care4Life mHealth disease management system (C4L) and a CHW. Hypotheses: 1. A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals. 2. A patient interactive cell phone disease management system will activate Medicaid patients with type 2 diabetes (DM2) to improve the composite of 7 wellness behaviors and 6 clinical outcomes by 25% or greater compared to baseline Expected Outcomes: Primary outcomes: 1. Superior improvement over baseline of the composite of Wellness Behaviors and Clinical Outcomes in the CHW plus C4L group compared to the CHW alone and cell phone alone groups. 2. Improvement by 25% or greater over baseline of the composite of Wellness Behaviors and Clinical Outcomes for patients using C4L alone. Secondary outcomes: Improvement in both clinical and behavior endpoints. Endpoints to be compared across the three treatment arms include: 1. mean HbA1c, 2. mean LDLc Cholesterol 3. average BP if hypertensive 4. Patient distress measured with Fisher Brief Diabetes Distress Screening Instrument 4\) Medication adherence measured with Morisky Medication Adherence Survey 5) Healthcare utilization: ER, acute clinic visits, hospitalizations Anticipated results and impact on healthcare: Mobile health has great potential to enhance DM2 patient health behaviors and clinical outcomes both alone and, even better, with assistance of a CHW. mHealth systems can be provided to a wide range of urban and rural DM2 patients resulting in an affordable, a more efficient patient-driven/centered health delivery system.
Interventions
BEHAVIORALmobile health care application
mobile health application for cell phones to assist patients in managing their diabetes.
BEHAVIORALCHWs and mobile health care application
CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.
BEHAVIORALCommunity Health Worker (CHW)
CHWs assist patients in managing their diabetes in various ways.
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 21 to 75 years old * Medicaid insurance coverage, Medicare insurance coverage or Affordable Health Care Act insurance coverage * Fluent in English or Spanish and able to read a text message * Diagnosed with diabetes mellitus type 2 and A1C is \> 8% Acceptable values will be either : * A1c obtained within one month prior to baseline (as long as there were no diabetes changes made during that month) or * A new A1c measured at the baseline screening visit. * Meets \< 10 of the wellness behaviors and clinical goals if diagnosed with hypertension Meets \< 9 of the wellness behaviors and clinical goals if not diagnosed with hypertension
Exclusion criteria
* Stage 5 chronic kidney disease or end stage renal disease on dialysis * Terminal illness (expected survival of less than one year) * Severe dementia or uncontrolled mental illness * Gestational diabetes mellitus * Use of an insulin pump * Inability to use a cellular phone * Unable to use software application on cellular phone * Pregnant or planning to get pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1 | baseline and 1 year | The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument | Baseline and 1 year | Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24. Low distress \< 12 : moderate / high distress \> or = 12. |
| Change in Hemoglobin A1C | Baseline and 1 year | Change in HbA1c after 1 year from baseline |
| Change in Medication Adherence | baseline and 1 year | Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 3 medical clinic sites in Washington DC. Each site had its' own Principal Investigator ,research coordinator and community health worker. Recruitment started April 2014 and ended July 2015. The study period for each participant was 1 year.
Participants by arm
| Arm | Count |
|---|---|
| Mobile Health Care Application Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes. | 56 |
| Community Health Worker (CHW) CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways. | 56 |
| CHWs and Mobile Health Care Application Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application. | 54 |
| Total | 166 |
Baseline characteristics
| Characteristic | Mobile Health Care Application | Community Health Worker (CHW) | CHWs and Mobile Health Care Application | Total |
|---|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 1.51 | 53.3 years STANDARD_DEVIATION 1.21 | 53.2 years STANDARD_DEVIATION 1.25 | 52.9 years STANDARD_DEVIATION 0.76 |
| Race/Ethnicity, Customized Black | 51 participants | 51 participants | 49 participants | 151 participants |
| Race/Ethnicity, Customized Other race | 5 participants | 5 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 37 Participants | 42 Participants | 41 Participants | 120 Participants |
| Sex: Female, Male Male | 19 Participants | 14 Participants | 13 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.
Time frame: baseline and 1 year
Population: Sample size estimates were based on the study hypotheses and the associated primary endpoint. Dropouts were analyzed using intention to treat methodology.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health Care Application | Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1 | -1.5 incomplete behaviors/goals | Standard Error 0.17 |
| Community Health Worker (CHW) | Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1 | -1.7 incomplete behaviors/goals | Standard Error 0.29 |
| CHWs and Mobile Health Care Application | Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1 | -1.1 incomplete behaviors/goals | Standard Error 0.29 |
p-value: <0.0001Chi-squared
Secondary
Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument
Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24. Low distress \< 12 : moderate / high distress \> or = 12.
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health Care Application | Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument | -3.5 units on a scale | Standard Error 0.71 |
| Community Health Worker (CHW) | Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument | -3.7 units on a scale | Standard Error 1.1 |
| CHWs and Mobile Health Care Application | Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument | -4.4 units on a scale | Standard Error 0.89 |
p-value: <0.0001Chi-squared
Secondary
Change in Hemoglobin A1C
Change in HbA1c after 1 year from baseline
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health Care Application | Change in Hemoglobin A1C | -1.3 Percentage of total hemoglobin | Standard Error 0.2 |
| Community Health Worker (CHW) | Change in Hemoglobin A1C | -1.2 Percentage of total hemoglobin | Standard Error 0.38 |
| CHWs and Mobile Health Care Application | Change in Hemoglobin A1C | -1.2 Percentage of total hemoglobin | Standard Error 0.37 |
p-value: <0.0001Chi-squared
Secondary
Change in Medication Adherence
Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent
Time frame: baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health Care Application | Change in Medication Adherence | 0.4 units on a scale | Standard Deviation 0.19 |
| Community Health Worker (CHW) | Change in Medication Adherence | 0.09 units on a scale | Standard Deviation 0.24 |
| CHWs and Mobile Health Care Application | Change in Medication Adherence | 0.3 units on a scale | Standard Deviation 0.31 |
p-value: 0.02Wilcoxon signed rank