Diabetes Mellitus Type IINCT06542939
Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension (Phase II)
A study testing Integrated CHW Intervention and CHW Session 1 Only in people with Diabetes Mellitus Type II and Hypertension, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus Type II, Hypertension
- What is being tested?
- Integrated CHW Intervention and CHW Session 1 Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Nov 2024to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- identified as of South Asian ethnicity
- at least 21 years of age
- a diagnosis of diabetes
- a diagnosis of hypertension
- an uncontrolled BP reading (>130/80mmHg) in the last 6 months
Who cannot join
- Under the age of 21
- Women who are pregnant at the time of screening
- Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
- Inability to perform unsupervised physical activity
- Malignancy or life-threatening illness with life expectancy of <5 years
- Diagnosed cognitive deficits or limited decision-making capacity
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Emory University
Atlanta, Georgia, 30322
NYU Langone Health
New York, New York, 10016
About this study
The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.
- Conditions
- Diabetes Mellitus Type II, Hypertension
- Being tested
- Integrated CHW Intervention, CHW Session 1 Only
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated CHW InterventionBehavioural
Participants will undergo all 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources. There will be two one-on-one virtual meetings, up to 9 follow-up phone calls to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.
CHW Session 1 OnlyBehavioural
Participants will attend only the first group-based health education session on hypertension and diabetes management.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Workers (CHW) treatment group | Experimental | There is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings. Receives: Behavioral: Integrated CHW Intervention |
| Control group | Active comparator | The control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions. Receives: Behavioral: CHW Session 1 Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants achieving BP control, defined as <130/80 mmHg
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months.
Measured: Month 6
Secondary outcomes (9)
Percent of participants achieving BP control, defined as <130/80 mmHg
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at twelve months.
Measured: Month 12
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 6
Change from Baseline in HbA1c levels at Month 12
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 12
Change from Baseline in Body mass index (BMI) at Month 6
Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 6
Change from Baseline in BMI at Month 12
Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 12
Change from Baseline in Systolic blood pressure (SBP) at Month 6
Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 6
Change from Baseline in SBP at Month 12
Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 12
Change from Baseline in Diastolic blood pressure (DBP) at Month 6
Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 6
Change from Baseline in DBP at Month 12
Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start11 Nov 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IIStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542939
- Sponsor's protocol ID
- 19-01192-2
- Other IDs
- 5R01MD018528-02
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: laura.wyatt@nyulangone.org . The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension (Phase II)
- ClinicalTrials.gov ID
- NCT06542939
- Acronym / sponsor ID
- 19-01192-2
- Conditions
- Diabetes Mellitus Type II, Hypertension
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 7 Aug 2024 (actual)
- 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.
The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Workers (CHW) treatment group | Experimental | Behavioral: Integrated CHW InterventionThere is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings. |
| Control group | Active comparator | Behavioral: CHW Session 1 OnlyThe control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- identified as of South Asian ethnicity
- at least 21 years of age
- a diagnosis of diabetes
- a diagnosis of hypertension
- an uncontrolled BP reading (>130/80mmHg) in the last 6 months
Key exclusion criteria (6 listed)
- Under the age of 21
- Women who are pregnant at the time of screening
- Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
- Inability to perform unsupervised physical activity
- Malignancy or life-threatening illness with life expectancy of <5 years
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 |
|---|---|---|
| Integrated CHW InterventionParticipants will undergo all 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources. There will be two one-on-one virtual meetings, up to 9 follow-up phone calls to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc. | Behavioural | Community Health Workers (CHW) treatment group |
| CHW Session 1 OnlyParticipants will attend only the first group-based health education session on hypertension and diabetes management. | Behavioural | Control group |
Primary outcome
Percent of participants achieving BP control, defined as <130/80 mmHg
Time frame: Month 6
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months.
9 secondary outcomes
Percent of participants achieving BP control, defined as <130/80 mmHg
Time frame: Month 12
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
Time frame: Baseline, Month 6
Change from Baseline in HbA1c levels at Month 12
Time frame: Baseline, Month 12
Change from Baseline in Body mass index (BMI) at Month 6
Time frame: Baseline, Month 6
Change from Baseline in BMI at Month 12
Time frame: Baseline, Month 12
Change from Baseline in Systolic blood pressure (SBP) at Month 6
Time frame: Baseline, Month 6
Change from Baseline in SBP at Month 12
Time frame: Baseline, Month 12
Change from Baseline in Diastolic blood pressure (DBP) at Month 6
Time frame: Baseline, Month 6
Change from Baseline in DBP at Month 12
Time frame: Baseline, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: laura.wyatt@nyulangone.org . The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Diabetes Mellitus Type II
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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Nadia Islam, PhD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated CHW Intervention and CHW Session 1 Only in people with Diabetes Mellitus Type II and Hypertension, run by NYU Langone Health at 2 sites 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 6 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: enrolling by invitation, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 participants achieving BP control, defined as <130/80 mmHg (time frame: Month 6). 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 1 Oct 2026.