DiabetesEQUIPED-ADRDNCT03723707

Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

A study testing EQUIPED-ADRD Intervention in people with Diabetes and Dementia, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to develop and test a care quality improvement intervention featuring use of consensus decisional guidance for the medical management of diabetes (DM) in patients with Alzheimer's disease and related dementia (ADRD) in primary care, provider (PCP) workflow enhancements supported by a panel… Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Diabetes, Dementia, Alzheimer Disease
What is being tested?: EQUIPED-ADRD Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 355 participants
Where: 1 siteUnited States
Study dates: 3 Dec 2018to 20 Oct 2022
Phase: Interventional
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Patient must receive care at participating NYU FGP clinics.
Patient must be English or Spanish speaking.
Patient must have DM diagnosis.
Patient must have documented cognitive impairment or an ADRD diagnosis.
Patient must have someone who is identified as a family or friend who provides caregiving assistance.
Caregiver:

Show all 10Show fewer

Caregiver must have adequate knowledge of identified patient and/or participate in that member's healthcare decisions.
Caregiver must be English or Spanish speaking.
Caregiver must demonstrate capacity to consent to research participation.
Caregiver must be at least 21 years old.

Who cannot join

Patient:
Patient does not receive care at participating NYU FGP clinics.
Patient is not 65 years and older.
Patient is not English or Spanish speaking.
Patient does not have DM diagnosis.
Patient does not have documented Cognitive impairment or an ADRD diagnosis.

Show all 13Show fewer

Patient has severe dementia, other terminal illness with <6 months to live, and/or is hospice eligible.
Patient does not have a caregiver.
Caregiver:
Caregiver does not have adequate knowledge of identified patient and/or does not participate in that member's healthcare decisions.
Caregiver is not English or Spanish speaking.
Caregiver lacks capacity to consent to research.
Caregiver is under 21 years old.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

Conditions: Diabetes, Dementia, Alzheimer Disease
Being tested: EQUIPED-ADRD Intervention, Control (CON)
Medical subject headings: Diabetes Mellitus, Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EQUIPED-ADRD InterventionBehavioural
(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)
Control (CON)Behavioural
Will use current guidelines for primary care treatment with Diabetes and Dementia

Study groups in NCT03723707
Study group	Role	What they receive
Intervention (INT)	Experimental	(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) Receives: Behavioral: EQUIPED-ADRD Intervention
Control (CON)	Placebo comparator	During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Receives: Behavioral: Control (CON)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Patients Who Reach Consensus Target HBA1c
Percentage of patients with normal HbA1c (>=7 and <=8.5) at the end of the trial after completing the 24-month Follow-up and who had reported values in their electronic health record within 6 months of study completion.
Measured: Up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 201820 Oct 2022

First posted29 Oct 2018
Study start3 Dec 2018
Primary completion20 Oct 2022
Study completion20 Oct 2022

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 DiabetesStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 355 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03723707
Sponsor's protocol ID: s18-01166
Other IDs: 1R21AG057291-01
Acronym: EQUIPED-ADRD
Status last verified: Nov 2023
First submitted: 22 Oct 2018
Last updated: 9 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification and publication.

Publications

Adeyemi O, Christina W, Arcila-Mesa M, Dickson VV, Ferris R, Tarpey T, Fletcher J, Blaum C, Chodosh J. Enhanced quality in primary care for elders with diabetes and dementia: Protocol for a multisite randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108165. doi: 10.1016/j.cct.2025.108165. Epub 2025 Nov 24.
PubMed 41297852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
ClinicalTrials.gov ID: NCT03723707
Acronym / sponsor ID: EQUIPED-ADRD / s18-01166
Conditions: Diabetes, Dementia, Alzheimer Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 355 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 3 Dec 2018 (actual)
Primary completion: 20 Oct 2022 (actual)
Study completion: 20 Oct 2022 (actual)
First posted: 29 Oct 2018 (actual)
Results: Posted 9 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention (INT)	Experimental	Behavioral: EQUIPED-ADRD Intervention(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)
Control (CON)	Placebo comparator	Behavioral: Control (CON)During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (10 listed)

Patient must receive care at participating NYU FGP clinics.
Patient must be English or Spanish speaking.
Patient must have DM diagnosis.
Patient must have documented cognitive impairment or an ADRD diagnosis.
Patient must have someone who is identified as a family or friend who provides caregiving assistance.

Key exclusion criteria (13 listed)

Patient does not receive care at participating NYU FGP clinics.
Patient is not 65 years and older.
Patient is not English or Spanish speaking.
Patient does not have DM diagnosis.
Patient does not have documented Cognitive impairment or an ADRD diagnosis.

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
EQUIPED-ADRD Intervention(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)	Behavioural	Intervention (INT)
Control (CON)Will use current guidelines for primary care treatment with Diabetes and Dementia	Behavioural	Control (CON)

Primary outcome

Percent of Patients Who Reach Consensus Target HBA1c
Time frame: Up to Month 24
Percentage of patients with normal HbA1c (>=7 and <=8.5) at the end of the trial after completing the 24-month Follow-up and who had reported values in their electronic health record within 6 months of study completion.

Results and safety

Results posted to the registry on 9 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention (INT)	191	68
Control (CON)	164	78

Primary outcome: Percent of Patients Who Reach Consensus Target HBA1c

Time frame: Up to Month 24. Mean (95% Confidence Interval). Unit: percentage of participants

Measure	Intervention (INT) n = 25	Control (CON) n = 32
Value	12 (-1.3 to 25.3)	18.75 (4.7 to 32.8)

Adverse events

Time frame: 24 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention (INT)	69 of 191 (36.1%)	0 of 191 (0%)	33 of 191
Control (CON)	65 of 164 (39.6%)	0 of 164 (0%)	32 of 164

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41297852Adeyemi O, Christina W, Arcila-Mesa M, Dickson VV, Ferris R, Tarpey T, Fletcher J, Blaum C, Chodosh J. Enhanced quality in primary care for elders with diabetes and dementia: Protocol for a multisite randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108165. doi: 10.1016/j.cct.2025.108165. Epub 2025 Nov 24.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification and publication.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

Joshua Chodosh, MD, MSHS, FACP principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EQUIPED-ADRD Intervention in people with Diabetes and Dementia, run by NYU Langone Health 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 10 inclusion and 13 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 9 Nov 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2023). 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?

Percent of Patients Who Reach Consensus Target HBA1c (time frame: Up to Month 24). 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 NCT03723707, 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 9 Nov 2023.