HypertensionCSDSNCT01918891
Center for Stroke Disparities Solution - Community Transitions Intervention
A study testing Nurse Practitioner Only and Nurse Practitioner + Health Coach in people with Hypertension and Stroke, run by Visiting Nurse Service of New York at 1 site in United States.
Trial summary
The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension, Stroke, Transient Ischemic Attack
- What is being tested?
- Nurse Practitioner Only and Nurse Practitioner + Health Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly admitted to the VNSNY post acute care program
- 21 years of age or older
- Black and/or Hispanic
- Speaks English or Spanish
- History of stroke or transient ischemic attack (TIA)
- Hypertension diagnosis
- Average screening systolic BP >= 140 mmHg
- Is available to participate in intervention activities during the study timeframe if randomized to treatment group
Who cannot join
- Dialysis
- End stage renal disease
- Kidney transplant
- Severe heart failure
- Significant cognitive impairment. Unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention
- Significant verbal speech impairment. Unable to participate in intervention telephone sessions
- Patients with upper arm circumference outside of valid use parameters for the automated device used for eligibility screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Visiting Nurse Service of New York
New York, New York, 10001
About this study
Official title: Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)
The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.
Read the detailed description
Targeted study participants are Black and Hispanic patients with a history of stroke and a current systolic blood pressure (BP) above JNC7 recommended range (>=140 mmHg) who recently entered home care service. The NP only program will provide a 30 day intervention while the NP/HC team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. As applicable, the HC will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.
- Conditions
- Hypertension, Stroke, Transient Ischemic Attack
- Being tested
- Nurse Practitioner Only, Nurse Practitioner + Health Coach
- Keywords
- stroke, transient ischemic attack, High blood pressure, Hypertension
- Medical subject headings
- Hypertension, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Practitioner OnlyBehavioural
Nurse Practitioner + Health CoachBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Home Care | No intervention | Regardless of study arm, all patients will receive usual home health services: a physician-ordered plan of care; skilled nursing and/or therapy services as prescribed by the MD; patient education, monitoring and hands-on care; and home health aide services depending on functional deficits and availability of unpaid caregivers. |
| Nurse Practitioner + Health Coach | Experimental | The NP + HC arm will include the same protocol as the NP only arm plus 30 additional days of support. The HC will pick up the case after the initial 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed. Receives: Behavioral: Nurse Practitioner Only; Behavioral: Nurse Practitioner + Health Coach |
| Nurse Practitioner Only | Experimental | The NP only program will provide a 30 day intervention via in-home and telephone encounters for patients randomized to this group. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. Receives: Behavioral: Nurse Practitioner Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of systolic blood pressure
Patients randomized to the NP only and the NP+HC transitional care interventions will have greater 3 and 12 month reduction in SBP than patients in Usual Home Care.
Measured: Baseline to 3 and 12 months.
Secondary outcomes (2)
Cost-effectiveness of NP-only and NP+HC relative to UHC
Both interventions will be more costly but more cost-effective than usual home care.
Measured: VNSNY home care admission to 3 and 12 months post admission
Influence on post-stroke patients' function and health-related quality of life (QoL)
Both interventions will yield significant comparative improvements in function and health-related QoL; NP+HC will be more effective than NP-only.
Measured: Baseline to 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visiting Nurse Service of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), NYU Langone Health, Hebrew Home at Riverdale, Columbia University
- Responsible party
- Sponsor
- Investigators
- Penny H Feldman, PhD, Principal investigator, Visiting Nurse Service of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918891
- Sponsor's protocol ID
- I12-004
- Other IDs
- 1U54NS081765
- Acronym
- CSDS
- Status last verified
- Sep 2019
- First submitted
- 5 Aug 2013
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Osakwe ZT, Barron Y, McDonald MV, Feldman PH. Effect of Nurse Practitioner Interventions on Hospitalizations in the Community Transitions Intervention Trial. Nurs Res. 2021 Jul-Aug 01;70(4):266-272. doi: 10.1097/NNR.0000000000000508.
PubMed 34160182Feldman PH, McDonald MV, Trachtenberg M, Trifilio M, Onorato N, Sridharan S, Silver S, Eimicke J, Teresi J. Reducing Hypertension in a Poststroke Black and Hispanic Home Care Population: Results of a Pragmatic Randomized Controlled Trial. Am J Hypertens. 2020 Apr 1;33(4):362-370. doi: 10.1093/ajh/hpz148.
PubMed 31541606Feldman PH, McDonald MV, Trachtenberg MA, Schoenthaler A, Coyne N, Teresi J. Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial. Trials. 2015 Jan 27;16:32. doi: 10.1186/s13063-015-0550-3.
PubMed 25622823
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)
- ClinicalTrials.gov ID
- NCT01918891
- Acronym / sponsor ID
- CSDS / I12-004
- Conditions
- Hypertension, Stroke, Transient Ischemic Attack
- Keywords
- stroke, transient ischemic attack, High blood pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Visiting Nurse Service of New YorkUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), NYU Langone Health, Hebrew Home at Riverdale, Columbia University
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 8 Aug 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.
The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.
Detailed description
Targeted study participants are Black and Hispanic patients with a history of stroke and a current systolic blood pressure (BP) above JNC7 recommended range (>=140 mmHg) who recently entered home care service. The NP only program will provide a 30 day intervention while the NP/HC team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. As applicable, the HC will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Home Care | No intervention | –Regardless of study arm, all patients will receive usual home health services: a physician-ordered plan of care; skilled nursing and/or therapy services as prescribed by the MD; patient education, monitoring and hands-on care; and home health aide services depending on functional deficits and availability of unpaid caregivers. |
| Nurse Practitioner + Health Coach | Experimental | Behavioral: Nurse Practitioner Only, Behavioral: Nurse Practitioner + Health CoachThe NP + HC arm will include the same protocol as the NP only arm plus 30 additional days of support. The HC will pick up the case after the initial 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed. |
| Nurse Practitioner Only | Experimental | Behavioral: Nurse Practitioner OnlyThe NP only program will provide a 30 day intervention via in-home and telephone encounters for patients randomized to this group. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly admitted to the VNSNY post acute care program
- 21 years of age or older
- Black and/or Hispanic
- Speaks English or Spanish
- History of stroke or transient ischemic attack (TIA)
Key exclusion criteria (7 listed)
- Dialysis
- End stage renal disease
- Kidney transplant
- Severe heart failure
- Significant cognitive impairment. Unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention
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 |
|---|---|---|
| Nurse Practitioner Only | Behavioural | Nurse Practitioner + Health Coach, Nurse Practitioner Only |
| Nurse Practitioner + Health Coach | Behavioural | Nurse Practitioner + Health Coach |
Primary outcome
Reduction of systolic blood pressure
Time frame: Baseline to 3 and 12 months.
Patients randomized to the NP only and the NP+HC transitional care interventions will have greater 3 and 12 month reduction in SBP than patients in Usual Home Care.
2 secondary outcomes
Cost-effectiveness of NP-only and NP+HC relative to UHC
Time frame: VNSNY home care admission to 3 and 12 months post admission
Influence on post-stroke patients' function and health-related quality of life (QoL)
Time frame: Baseline to 3 and 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 1 Oct 2019.
- Derived from this study: PubMed 34160182Osakwe ZT, Barron Y, McDonald MV, Feldman PH. Effect of Nurse Practitioner Interventions on Hospitalizations in the Community Transitions Intervention Trial. Nurs Res. 2021 Jul-Aug 01;70(4):266-272. doi: 10.1097/NNR.0000000000000508.
- Derived from this study: PubMed 31541606Feldman PH, McDonald MV, Trachtenberg M, Trifilio M, Onorato N, Sridharan S, Silver S, Eimicke J, Teresi J. Reducing Hypertension in a Poststroke Black and Hispanic Home Care Population: Results of a Pragmatic Randomized Controlled Trial. Am J Hypertens. 2020 Apr 1;33(4):362-370. doi: 10.1093/ajh/hpz148.
- Derived from this study: PubMed 25622823Feldman PH, McDonald MV, Trachtenberg MA, Schoenthaler A, Coyne N, Teresi J. Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial. Trials. 2015 Jan 27;16:32. doi: 10.1186/s13063-015-0550-3.
- NYU School of Medicine - Center for Stroke Disparities SolutionsLink 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.
Penny H Feldman, PhD principal investigator
Visiting Nurse Service of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Practitioner Only and Nurse Practitioner + Health Coach in people with Hypertension and Stroke, run by Visiting Nurse Service of New York 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 8 inclusion and 7 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 1 Oct 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.
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?
Reduction of systolic blood pressure (time frame: Baseline to 3 and 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 NCT01918891, which also lists 3 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 1 Oct 2019.