Medical Assistant Health Coaching for Diabetes in Diverse... | NCT02643797

Studies
Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

NCT02643797

Sponsor

Scripps Whittier Diabetes Institute

Status

Completed

Last Update Posted

Sep 27, 2021Actual

Enrollment

602Actual

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

Medical Assistant Health Coaching

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2016Actual

Primary Completion Date

Apr 19, 2020Actual

Completion Date

Apr 19, 2020Actual

First Submitted Date

Nov 30, 2015

First Submission Date that Met QC Criteria

Dec 28, 2015

First Posted Date

Dec 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Athena Philis-Tsimikas, Prinicipal Investigator, Scripps Whittier Diabetes InstitutePrincipal Investigator

Lead Sponsor

Scripps Whittier Diabetes InstituteOTHER

Collaborators

Name	Class
San Diego State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

602Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Medical Assistant Health Coaching	Behavioral	One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.	Intervention Group: MA Health Coaching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome		12 months
Patient Activation Measure (PAM) - patient-reported outcome		12 months

Other Outcomes

Measure	Description	Time Frame
Cost-effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model		12 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Athena Philis-Tsimikas, MD	Scripps Whittier Diabetes Institute	Principal Investigator
Linda Gallo, PhD	San Diego State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Whittier Diabetes Institute		La Jolla	California	92121	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided