Trial Outcomes & Findings for Changing the Healthcare Delivery Model (NCT NCT02093234)
NCT ID: NCT02093234
Last Updated: 2017-04-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
baseline and 1 year
Results posted on
2017-04-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
54
|
|
Overall Study
COMPLETED
|
53
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changing the Healthcare Delivery Model
Baseline characteristics by cohort
| Measure |
Mobile Health Care Application
n=56 Participants
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.
|
Community Health Worker (CHW)
n=56 Participants
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.
|
CHWs and Mobile Health Care Application
n=54 Participants
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.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 1.51 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 1.21 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 1.25 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 0.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
49 participants
n=5 Participants
|
151 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other race
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 yearPopulation: Sample size estimates were based on the study hypotheses and the associated primary endpoint. Dropouts were analyzed using intention to treat methodology.
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.
Outcome measures
| Measure |
Mobile Health Care Application
n=56 Participants
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.
|
Community Health Worker (CHW)
n=56 Participants
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.
|
CHWs and Mobile Health Care Application
n=54 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
|
-1.5 incomplete behaviors/goals
Standard Error 0.17
|
-1.7 incomplete behaviors/goals
Standard Error 0.29
|
-1.1 incomplete behaviors/goals
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline and 1 yearParticipants 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.
Outcome measures
| Measure |
Mobile Health Care Application
n=56 Participants
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.
|
Community Health Worker (CHW)
n=56 Participants
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.
|
CHWs and Mobile Health Care Application
n=54 Participants
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.
|
|---|---|---|---|
|
Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument
|
-3.5 units on a scale
Standard Error 0.71
|
-3.7 units on a scale
Standard Error 1.1
|
-4.4 units on a scale
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Baseline and 1 yearChange in HbA1c after 1 year from baseline
Outcome measures
| Measure |
Mobile Health Care Application
n=56 Participants
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.
|
Community Health Worker (CHW)
n=56 Participants
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.
|
CHWs and Mobile Health Care Application
n=54 Participants
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.
|
|---|---|---|---|
|
Change in Hemoglobin A1C
|
-1.3 Percentage of total hemoglobin
Standard Error 0.20
|
-1.2 Percentage of total hemoglobin
Standard Error 0.38
|
-1.2 Percentage of total hemoglobin
Standard Error 0.37
|
SECONDARY outcome
Timeframe: baseline and 1 yearMedication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent
Outcome measures
| Measure |
Mobile Health Care Application
n=53 Participants
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.
|
Community Health Worker (CHW)
n=52 Participants
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.
|
CHWs and Mobile Health Care Application
n=50 Participants
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.
|
|---|---|---|---|
|
Change in Medication Adherence
|
0.4 units on a scale
Standard Deviation 0.19
|
0.09 units on a scale
Standard Deviation 0.24
|
0.3 units on a scale
Standard Deviation 0.31
|
Adverse Events
Mobile Health Care Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Health Worker (CHW)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHWs and Mobile Health Care Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor will conduct a peer review of the research report before it may be published.
- Publication restrictions are in place
Restriction type: OTHER