NCT02910089

Brief Summary

The purpose of this study is to evaluate whether a combination of pharmacist-delivered patient engagement techniques improves disease control and medication adherence among patients with poorly-controlled diabetes compared with usual care. These engagement techniques include shared decision-making and brief negotiated interviewing and are delivered telephonically.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

October 20, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 29, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

August 4, 2016

Results QC Date

December 6, 2018

Last Update Submit

September 9, 2019

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycosylated Hemoglobin (HbA1c):

    Pre- to post-intervention change in mean HbA1c levels

    baseline and at the end of 12 months post index date

Secondary Outcomes (3)

  • Medication Adherence (PDC Measure)

    during follow-up period of 12 months post index date

  • Percentage (Proportion x 100) of Patients Achieving Optimal Adherence

    during follow-up period of 12 months post index date

  • Patients Achieving HbA1c

    baseline and at the end of 12 months post index date

Study Arms (2)

Shared Decision Making/Brief Negotiated Interviewing

OTHER

This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).

Behavioral: Shared Decision Making

Control Arm

NO INTERVENTION

Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.

Interventions

Shared Decision MakingBEHAVIORAL

This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).

Shared Decision Making/Brief Negotiated Interviewing

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Commercially-insured beneficiaries
  • Receive all medical/prescription drug benefits through Horizon
  • On ≥1 one oral hypoglycemic agent
  • Latest HbA1c measurement ≥ 8% (within previous 6 months)
  • Provided phone number to Horizon

You may not qualify if:

  • \- Currently using any insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Boston, Massachusetts, 2115, United States

Location

Related Publications (1)

  • Lauffenburger JC, Ghazinouri R, Jan S, Makanji S, Ferro CA, Lewey J, Wittbrodt E, Lee J, Haff N, Fontanet CP, Choudhry NK. Impact of a novel pharmacist-delivered behavioral intervention for patients with poorly-controlled diabetes: The ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic randomized trial. PLoS One. 2019 Apr 2;14(4):e0214754. doi: 10.1371/journal.pone.0214754. eCollection 2019.

    PMID: 30939143DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Evaluation of glycemic control is limited to participants who had baseline labs available. \~29% had missing outcomes data for the primary outcome; while we used multiple imputation to evaluate the study, this could have influenced the findings.

Results Point of Contact

Title
Susan Thomas, MD
Organization
Astrazeneca Pharmaceuticals
Susan.Thomas2@astrazeneca.com
302-886-5589

Study Officials

  • Niteesh K. Choudhry, MD, Ph.D

    Brigham Women's Health

    PRINCIPAL INVESTIGATOR

  • Eric Wittbrodt, PharmD, MPH

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

September 21, 2016

Study Start

October 20, 2016

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

September 17, 2019

Results First Posted

August 29, 2019

Record last verified: 2019-09

Locations

US(1)