NCT02643797

Brief Summary

This study is a cluster (clinic level) randomized pragmatic trial to compare the effectiveness of MA Health Coaching (MAC) delivered by non-clinician primary care staff (i.e., MAs) versus usual care (UC) in improving diabetes clinical control among individuals with poorly controlled type 2 diabetes mellitus (T2DM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
602

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2016

Typical duration for phase_3

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

November 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2020

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

4.1 years

First QC Date

November 30, 2015

Last Update Submit

September 20, 2021

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

diabetesmedical assistanthealth coachglycemic controlpragmatic trial

Outcome Measures

Primary Outcomes (3)

  • Glycosylated Hemoglobin (Hba1c); % units

    12 months

  • Low-density lipoprotein-cholesterol (LDL-c); mg/dL units

    12 months

  • Systolic blood pressure (SBP); mmHg units

    12 months

Secondary Outcomes (5)

  • Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome

    12 months

  • Patient Activation Measure (PAM) - patient-reported outcome

    12 months

  • Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome

    12 months

  • Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome

    12 months

  • Morisky Medication Adherence Scale (MMAS) - patient-reported outcome

    12 months

Other Outcomes (1)

  • Cost-effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model

    12 months

Study Arms (2)

Intervention Group: MA Health Coaching

EXPERIMENTAL

Patients in the intervention group will receive the "MA Health Coaching" intervention during their primary care visits, as well a follow-up calls to encourage/monitor progress and offer support.

Behavioral: Medical Assistant Health Coaching

Usual Care

NO INTERVENTION

Patients in this group will receive "treatment as usual" during their primary care visits.

Interventions

Medical Assistant Health CoachingBEHAVIORAL

One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.

Also known as: MAC
Intervention Group: MA Health Coaching

Eligibility Criteria

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

You may qualify if:

  • Must be a patient at selected Scripps or Neighborhood Healthcare clinic,
  • Must be age 18 years or older,
  • Must have a T2DM diagnosis,
  • Must show evidence of poor clinical control, defined as HbA1c ≥ 8% and/or LDL-C ≥ 100 mg/dL, and/or SBP ≥ 140 mmHg.

You may not qualify if:

  • None as this is a pragmatic trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Whittier Diabetes Institute

La Jolla, California, 92121, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Athena Philis-Tsimikas, MD

    Scripps Whittier Diabetes Institute

    PRINCIPAL INVESTIGATOR

  • Linda Gallo, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 31, 2015

Study Start

March 7, 2016

Primary Completion

April 19, 2020

Study Completion

April 19, 2020

Last Updated

September 27, 2021

Record last verified: 2021-09

Locations

US(1)