Diabetes Mellitus Type 2Phase 4ENGAGE-DMNCT02910089
ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
A Phase 4 study testing Shared Decision Making in people with Diabetes Mellitus Type 2, run by AstraZeneca at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Shared Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2016to 20 Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently using any insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM): A 12-month Study of the Impact of Combined Shared-decision Making and Brief Negotiated Interviewing on Disease Control and Medication Adherence in Patients With Diabetes
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.
Read the detailed description
The US is facing a growing epidemic of type 2 diabetes. Among patients with poorly controlled diabetes, it is often not clear whether the problem is attributable to failure to appropriately intensify therapy, poor adherence to prescribed medications, unwillingness to accept new treatments or a combination of these factors. Multi-component pharmacist-delivered interventions, particularly those rooted in patient engagement, have been shown to be some of the most effective at improving adherence to chronic disease medications. Even though shared decision making and brief negotiated interviewing are complementary patient engagement techniques, the effectiveness of combining these 2 intervention approaches, especially in the management of diabetes, is unknown.
In this study of patients using at least one oral hypoglycemic therapy with poorly controlled disease, the investigators examine the impact of a shared decision making and behavioral interviewing intervention delivered telephonically by pharmacists, compared with usual care. Briefly, all patients allocated to the intervention will be mailed a patient decision aid to prime them for encounters with pharmacists. After receiving the decision aid, these patients will be asked to engage in and provide informed consent for at least 4 telephonic discussions with pharmacists about their diabetes treatment options, goals, and preferences, medication adherence, strategies for reducing adherence barriers, and the benefits of maintaining blood glucose control. The study is being conducted within a large insurer and consists of 700 patients each allocated to the intervention group and the control group. Analyses will be performed on an intent-to-treat basis.
After study completion, the investigators will also use predictive analytics to examine whether treatment response could be predicted based on patient characteristics, such as sociodemographic, clinical, medication use, and other motivational characteristics, which will provide information about which patients are most likely to benefit from the intervention.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Shared Decision Making
- Keywords
- Diabetes Mellitus Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision MakingBehavioural
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making/Brief Negotiated Interviewing | Other | This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin (HbA1c):
Pre- to post-intervention change in mean HbA1c levels
Measured: baseline and at the end of 12 months post index date
Secondary outcomes (3)
Medication Adherence (PDC Measure)
Mean Adherence (PDC) in each study arm in the follow-up period
Measured: during follow-up period of 12 months post index date
Percentage (Proportion x 100) of Patients Achieving Optimal Adherence
Percentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC ≥0.80) in the follow-up period
Measured: during follow-up period of 12 months post index date
Patients Achieving HbA1c
Percentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period
Measured: baseline and at the end of 12 months post index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start20 Oct 2016
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham Women's Health
- Responsible party
- Sponsor
- Investigators
- Niteesh K. Choudhry, MD, Ph.D, Principal investigator, Brigham Women's HealthEric Wittbrodt, PharmD, MPH, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910089
- Sponsor's protocol ID
- D1843R00254
- Acronym
- ENGAGE-DM
- Status last verified
- Sep 2019
- First submitted
- 4 Aug 2016
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30939143
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM): A 12-month Study of the Impact of Combined Shared-decision Making and Brief Negotiated Interviewing on Disease Control and Medication Adherence in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02910089
- Acronym / sponsor ID
- ENGAGE-DM / D1843R00254
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes Mellitus Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Brigham Women's Health
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The US is facing a growing epidemic of type 2 diabetes. Among patients with poorly controlled diabetes, it is often not clear whether the problem is attributable to failure to appropriately intensify therapy, poor adherence to prescribed medications, unwillingness to accept new treatments or a combination of these factors. Multi-component pharmacist-delivered interventions, particularly those rooted in patient engagement, have been shown to be some of the most effective at improving adherence to chronic disease medications. Even though shared decision making and brief negotiated interviewing are complementary patient engagement techniques, the effectiveness of combining these 2 intervention approaches, especially in the management of diabetes, is unknown.
In this study of patients using at least one oral hypoglycemic therapy with poorly controlled disease, the investigators examine the impact of a shared decision making and behavioral interviewing intervention delivered telephonically by pharmacists, compared with usual care. Briefly, all patients allocated to the intervention will be mailed a patient decision aid to prime them for encounters with pharmacists. After receiving the decision aid, these patients will be asked to engage in and provide informed consent for at least 4 telephonic discussions with pharmacists about their diabetes treatment options, goals, and preferences, medication adherence, strategies for reducing adherence barriers, and the benefits of maintaining blood glucose control. The study is being conducted within a large insurer and consists of 700 patients each allocated to the intervention group and the control group. Analyses will be performed on an intent-to-treat basis.
After study completion, the investigators will also use predictive analytics to examine whether treatment response could be predicted based on patient characteristics, such as sociodemographic, clinical, medication use, and other motivational characteristics, which will provide information about which patients are most likely to benefit from the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making/Brief Negotiated Interviewing | Other | Behavioral: Shared Decision MakingThis prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ). |
| 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Currently using any insulin
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 |
|---|---|---|
| Shared Decision MakingThis prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ). | Behavioural | Shared Decision Making/Brief Negotiated Interviewing |
Primary outcome
Glycosylated Hemoglobin (HbA1c):
Time frame: baseline and at the end of 12 months post index date
Pre- to post-intervention change in mean HbA1c levels
3 secondary outcomes
Medication Adherence (PDC Measure)
Time frame: during follow-up period of 12 months post index date
Percentage (Proportion x 100) of Patients Achieving Optimal Adherence
Time frame: during follow-up period of 12 months post index date
Patients Achieving HbA1c
Time frame: baseline and at the end of 12 months post index date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30939143Lauffenburger 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.
- D1843R00254\_ENGAGE\_SAP\_RedactedPDFALink provided by the sponsor.
- D1843R00254\_ENGAGE\_Protocol\_redactedPDFALink provided by the sponsor.
- D1843R00254\_ENGAGE\_SAP\_RedactedPDFALink provided by the sponsor.
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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.
Niteesh K. Choudhry, MD, Ph.D principal investigator
Brigham Women's Health
Eric Wittbrodt, PharmD, MPH study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shared Decision Making in people with Diabetes Mellitus Type 2, run by AstraZeneca 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 5 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 17 Sep 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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): (time frame: baseline and at the end of 12 months post index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910089, which also lists 1 linked publication.
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 17 Sep 2019.