Type 2 Diabetes Mellitus (T2DM)Phase 3MACNCT02643797
Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
A Phase 3 study testing Medical Assistant Health Coaching in people with Type 2 Diabetes Mellitus (T2DM), run by Scripps Whittier Diabetes Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Medical Assistant Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2016to 19 Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None as this is a pragmatic trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Whittier Diabetes Institute
La Jolla, California, 92121
About this study
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).
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Medical Assistant Health Coaching
- Keywords
- diabetes, medical assistant, health coach, glycemic control, pragmatic trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Assistant Health CoachingBehavioural
Also called MAC
One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Medical Assistant Health Coaching |
| Usual Care | No intervention | Patients in this group will receive "treatment as usual" during their primary care visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin (Hba1c); % units
Measured: 12 months
Low-density lipoprotein-cholesterol (LDL-c); mg/dL units
Measured: 12 months
Systolic blood pressure (SBP); mmHg units
Measured: 12 months
Secondary outcomes (5)
Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome
Measured: 12 months
Patient Activation Measure (PAM) - patient-reported outcome
Measured: 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome
Measured: 12 months
Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome
Measured: 12 months
Morisky Medication Adherence Scale (MMAS) - patient-reported outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start7 Mar 2016
- Primary completion19 Apr 2020
- Study completion19 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Whittier Diabetes InstituteLinda Gallo, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643797
- Sponsor's protocol ID
- R18DK104250-01A1
- Acronym
- MAC
- Status last verified
- Sep 2021
- First submitted
- 30 Nov 2015
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
- ClinicalTrials.gov ID
- NCT02643797
- Acronym / sponsor ID
- MAC / R18DK104250-01A1
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- diabetes, medical assistant, health coach, glycemic control, pragmatic trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 19 Apr 2020 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: MA Health Coaching | Experimental | Behavioral: Medical Assistant Health CoachingPatients 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. |
| Usual Care | No intervention | –Patients in this group will receive "treatment as usual" during their primary care visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None as this is a pragmatic trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Assistant Health CoachingAlso: MACOne-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes. | Behavioural | Intervention Group: MA Health Coaching |
Primary outcome
Glycosylated Hemoglobin (Hba1c); % units
Time frame: 12 months
Low-density lipoprotein-cholesterol (LDL-c); mg/dL units
Time frame: 12 months
Systolic blood pressure (SBP); mmHg units
Time frame: 12 months
5 secondary outcomes
Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome
Time frame: 12 months
Patient Activation Measure (PAM) - patient-reported outcome
Time frame: 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome
Time frame: 12 months
Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome
Time frame: 12 months
Morisky Medication Adherence Scale (MMAS) - patient-reported outcome
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athena Philis-Tsimikas, MD principal investigator
Scripps Whittier Diabetes Institute
Linda Gallo, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medical Assistant Health Coaching in people with Type 2 Diabetes Mellitus (T2DM), run by Scripps Whittier Diabetes Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated Hemoglobin (Hba1c); % units (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.