Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-02-08 @ 3:29 PM
Study NCT ID:
NCT02093234
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2014-03-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changing the Healthcare Delivery Model
Sponsor:
George Washington University
Organization:
Study Overview
Official Title:
Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C4H
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IH-1304-6797 | OTHER_GRANT | PCORI | View |