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Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings (MAC)

Primary Purpose

Type 2 Diabetes Mellitus (T2DM)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Medical Assistant Health Coaching
Sponsored by
Scripps Whittier Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus (T2DM) focused on measuring diabetes, medical assistant, health coach, glycemic control, pragmatic trial

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

None as this is a pragmatic trial.

Sites / Locations

  • Scripps Whittier Diabetes Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group: MA Health Coaching

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Glycosylated Hemoglobin (Hba1c); % units
Low-density lipoprotein-cholesterol (LDL-c); mg/dL units
Systolic blood pressure (SBP); mmHg units

Secondary Outcome Measures

Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome
Patient Activation Measure (PAM) - patient-reported outcome
Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome
Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome
Morisky Medication Adherence Scale (MMAS) - patient-reported outcome

Full Information

First Posted
November 30, 2015
Last Updated
September 20, 2021
Sponsor
Scripps Whittier Diabetes Institute
Collaborators
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT02643797
Brief Title
Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
Acronym
MAC
Official Title
Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2016 (Actual)
Primary Completion Date
April 19, 2020 (Actual)
Study Completion Date
April 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Whittier Diabetes Institute
Collaborators
San Diego State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
The study will be conducted in the primary care environments of two distinct, yet representative healthcare systems in San Diego County: Neighborhood Healthcare (a San Diego County FQHC system and designated Patient-Centered Medical Home, serving predominantly ethnic minority, low income patients) and Scripps (a large, non-profit, private insurance-based health system, serving predominantly Caucasian, middle-to-higher income patients). Six hundred patients at intervention (n=2; patient N=300) and control (n=2; patient N=300) clinics, aged 18 and older, with T2DM, and glycosylated hemoglobin (HbA1c) ≥ 8.0%, and/or low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL, and/or systolic blood pressure (SBP) ≥ 140 within the last 60 days, will be identified and enrolled using electronic health records (EHRs). Primary clinical outcomes of HbA1c, LDL-C, and SBP assessed as part of quarterly (or annual, for LDL-C), standard-of-care medical visits will be extracted from EHRs over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (quality of life, patient activation) outcomes will be evaluated via telephone assessment in a subset of intervention and control (N=300 total) participants at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient, MA, and primary care provider perspectives. Cost-effectiveness will also be examined from the health system perspective. Principles of community engaged research were incorporated in intervention and study planning and will be sustained throughout the research period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus (T2DM)
Keywords
diabetes, medical assistant, health coach, glycemic control, pragmatic trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group: MA Health Coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in this group will receive "treatment as usual" during their primary care visits.
Intervention Type
Behavioral
Intervention Name(s)
Medical Assistant Health Coaching
Other Intervention Name(s)
MAC
Intervention Description
One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.
Primary Outcome Measure Information:
Title
Glycosylated Hemoglobin (Hba1c); % units
Time Frame
12 months
Title
Low-density lipoprotein-cholesterol (LDL-c); mg/dL units
Time Frame
12 months
Title
Systolic blood pressure (SBP); mmHg units
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome
Time Frame
12 months
Title
Patient Activation Measure (PAM) - patient-reported outcome
Time Frame
12 months
Title
Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome
Time Frame
12 months
Title
Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome
Time Frame
12 months
Title
Morisky Medication Adherence Scale (MMAS) - patient-reported outcome
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: None as this is a pragmatic trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Philis-Tsimikas, MD
Organizational Affiliation
Scripps Whittier Diabetes Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Gallo, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Whittier Diabetes Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

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