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

NCT ID: NCT03363100

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2019-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Digital health Partnership program

Intervention Type BEHAVIORAL

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital health Partnership program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humana Co.Ltd.

INDUSTRY

Sponsor Role collaborator

Evidation Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Evidation Health

San Mateo, California, United States

Site Status

Countries

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United States

Other Identifiers

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EH-006

Identifier Type: -

Identifier Source: org_study_id

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