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Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital health Partnership program
Sponsored by
Evidation Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Humana Medicare Advantage member
  • Type 2 diabetes diagnosis
  • HbA1c levels ≥ 8.0% verified by lab test

Exclusion Criteria:

  • Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease
  • Not fluent in English
  • Humana membership is part of a Full or Global risk arrangement
  • Enrolled in Humana at Home Care Management

Sites / Locations

  • Evidation Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

A1c
Change in A1c from study baseline to study end for participants

Secondary Outcome Measures

Full Information

First Posted
November 30, 2017
Last Updated
July 30, 2019
Sponsor
Evidation Health
Collaborators
Humana Co.Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03363100
Brief Title
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
Official Title
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
February 23, 2019 (Actual)
Study Completion Date
February 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evidation Health
Collaborators
Humana Co.Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Diabetes Coaching Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Health Partnership on A1c levels for individuals with uncontrolled Type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
624 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Digital health Partnership program
Intervention Description
The program pairs patients with their own certified diabetes educator coach who will guide the patient through a personalized program that leverages a proven educational curriculum combined with proven patient engagement methods.
Primary Outcome Measure Information:
Title
A1c
Description
Change in A1c from study baseline to study end for participants
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Humana Medicare Advantage member Type 2 diabetes diagnosis HbA1c levels ≥ 8.0% verified by lab test Exclusion Criteria: Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease Not fluent in English Humana membership is part of a Full or Global risk arrangement Enrolled in Humana at Home Care Management
Facility Information:
Facility Name
Evidation Health
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c

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