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

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ClinicalTrials.gov Identifier: NCT03363100
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Humana Co.Ltd.
Information provided by (Responsible Party):
Evidation Health

November 30, 2017
December 6, 2017
December 6, 2017
November 16, 2017
September 3, 2018   (Final data collection date for primary outcome measure)
A1c [ Time Frame: Baseline and 6 months ]
Change in A1c from study baseline to study end for participants
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Diabetes Mellitus, Type 2
Behavioral: 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.
  • Experimental: Intervention
    Intervention: Behavioral: Digital health Partnership program
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
578
Same as current
October 1, 2018
September 3, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jessie L Juusola, PhD 415-878-6508 humanaglucose@myachievement.com
United States
 
 
NCT03363100
EH-006
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Evidation Health
Evidation Health
Humana Co.Ltd.
Not Provided
Evidation Health
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP