StrokeNCT02011685
Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
A study testing Home BP Telemonitoring (HBPTM) and Nurse Case Management (NCM) in people with Stroke and Hypertension, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hypertension
- What is being tested?
- Home BP Telemonitoring (HBPTM) and Nurse Case Management (NCM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2014to 31 Dec 2019
- Phase
- Interventional
- 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
- Black or Hispanic
- Age 18 years or older
- English or Spanish speaking
- Patients who have had an ischemic or hemorrhagic stroke
- Modified Rankin scale score of ≤ 3
- Average screening SBP ≥ 140 mm Hg from three BP readings taken at two separate visits with a validated automated device
- Receiving care at the study site for at least 6 months and planning to continue receiving care at the site for the next two years.
Who cannot join
- Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the HBPTM or interacting with the NCM if he/she were to be randomized to the intervention group)
- Participation in other clinical trials
- Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record)
- Patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large BP cuff
- Diagnosis of dialysis or end stage renal disease
- Relocating out of area or extended travel during study period
- Significant verbal speech impairment; unable to participate in intervention telephone sessions
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.
- Conditions
- Stroke, Hypertension
- Being tested
- Home BP Telemonitoring (HBPTM), Nurse Case Management (NCM)
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home BP Telemonitoring (HBPTM)Behavioural
Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.
Nurse Case Management (NCM)Behavioural
Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers).
| Study group | Role | What they receive |
|---|---|---|
| Home BP Telemonitoring (HBPTM) | Active comparator | Participants will take home BP readings 3 days per week (morning and evening) for one week out of each month during the 12-month intervention. Receives: Behavioral: Home BP Telemonitoring (HBPTM) |
| HBPTM + Nurse Case Management (NCM) | Experimental | Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention. Receives: Behavioral: Home BP Telemonitoring (HBPTM); Behavioral: Nurse Case Management (NCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month systolic blood pressure (SBP) change
Measured: Baseline, 12 months
Secondary outcomes (3)
24-month stroke recurrence
Measured: 24 months
Cost-effectiveness for reducing SBP at 12 months
Measured: 12 months
Cost-effectiveness for reducing stroke recurrence at 24 months
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start18 Apr 2014
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011685
- Sponsor's protocol ID
- 13-00281
- Other IDs
- U54NS081765-5162, U54NS081765
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2013
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ogedegbe G, Teresi JA, Williams SK, Ogunlade A, Izeogu C, Eimicke JP, Kong J, Silver SA, Williams O, Valsamis H, Law S, Levine SR, Waddy SP, Spruill TM. Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial. JAMA. 2024 Jul 2;332(1):41-50. doi: 10.1001/jama.2024.6609.
PubMed 38842799Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.
PubMed 25873044
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
- ClinicalTrials.gov ID
- NCT02011685
- Acronym / sponsor ID
- 13-00281
- Conditions
- Stroke, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 18 Apr 2014 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Dec 2013 (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 will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home BP Telemonitoring (HBPTM) | Active comparator | Behavioral: Home BP Telemonitoring (HBPTM)Participants will take home BP readings 3 days per week (morning and evening) for one week out of each month during the 12-month intervention. |
| HBPTM + Nurse Case Management (NCM) | Experimental | Behavioral: Home BP Telemonitoring (HBPTM), Behavioral: Nurse Case Management (NCM)Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Black or Hispanic
- Age 18 years or older
- English or Spanish speaking
- Patients who have had an ischemic or hemorrhagic stroke
- Modified Rankin scale score of ≤ 3
Key exclusion criteria (8 listed)
- Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the HBPTM or interacting with the NCM if he/she were to be randomized to the intervention group)
- Participation in other clinical trials
- Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record)
- Patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large BP cuff
- Diagnosis of dialysis or end stage renal disease
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 |
|---|---|---|
| Home BP Telemonitoring (HBPTM)Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments. | Behavioural | HBPTM + Nurse Case Management (NCM), Home BP Telemonitoring (HBPTM) |
| Nurse Case Management (NCM)Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers). | Behavioural | HBPTM + Nurse Case Management (NCM) |
Primary outcome
12-month systolic blood pressure (SBP) change
Time frame: Baseline, 12 months
3 secondary outcomes
24-month stroke recurrence
Time frame: 24 months
Cost-effectiveness for reducing SBP at 12 months
Time frame: 12 months
Cost-effectiveness for reducing stroke recurrence at 24 months
Time frame: 24 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 18 Feb 2022.
- Derived from this study: PubMed 38842799Ogedegbe G, Teresi JA, Williams SK, Ogunlade A, Izeogu C, Eimicke JP, Kong J, Silver SA, Williams O, Valsamis H, Law S, Levine SR, Waddy SP, Spruill TM. Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial. JAMA. 2024 Jul 2;332(1):41-50. doi: 10.1001/jama.2024.6609.
- Derived from this study: PubMed 25873044Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home BP Telemonitoring (HBPTM) and Nurse Case Management (NCM) in people with Stroke and Hypertension, 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 7 inclusion and 8 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 18 Feb 2022. 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.
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?
12-month systolic blood pressure (SBP) change (time frame: Baseline, 12 months). 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 NCT02011685, which also lists 2 linked publications.
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 18 Feb 2022.