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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model [called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STOP model | Experimental | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is < 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment. |
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| Usual Care | Active Comparator | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Packet | Behavioral | The patient will receive an educational packet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Daytime Ambulatory Systolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime Ambulatory Diastolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | 6 months |
| Night Time Ambulatory Systolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire | 6 months | |
| Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS) | 6 months | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anjail Sharrief | The University Of Texas Health Science Center of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | STOP Model | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is < 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2020 |
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| Phone call at 72 hours by discharge nurse navigator | Behavioral | Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments |
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| Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge | Behavioral | A stroke prevention trained nurse practitioner or MD or social worker will review the participant's hospital records and depression, dietary, and sleep apnea screens,will reinforce the care plan based on patient-specific needs.They will counsel patients on salt reduction, the Mediterranean diet, and the importance of diet and exercise for stroke prevention.Along with the pharmacist they will also review the BP data to determine the need for medication adjustment and will discuss the side effects and interactions.The social worker will assess the need for medication assistance and other resources. The care plan will be shared with primary care providers (PCP)and patients will be referred to a PCP if they do not have one. The social worker will also will assist uninsured patients in applying for Texas County Indigent Care programs. |
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| Educational messages every other week | Behavioral | The messages will be sent to the participants cellular phones and will contain one of the following: a reminder to monitor BP, information from about lifestyle and diet for BP reduction, or a message from the pharmacist about medication adherence |
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| BP monitoring by QardioARM with periodic transmission of BP data | Diagnostic Test | Participants will be prompted to transmit BP logs through the telemonitoring device every 2 weeks until average BP is < 130/80, then monthly thereafter. Uncontrolled BP will prompt a call from the pharmacist to discuss medication adherence and the need for further titration. |
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| 6 months |
| Nighttime Diastolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | 6 months |
| Body Mass Index(BMI) | BMI will be calculated from height and weight. | 6 months |
| Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death) | Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death. | 6 months |
| Number of Participants With Acute Healthcare Utilization | Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care. | 6 months |
| Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES) |
| 6 months |
| Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES) | Baseline |
| FG001 | Usual Care | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet. Educational Packet: The patient will receive an educational packet. Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | STOP Model | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is < 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment. |
| BG001 | Usual Care | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet. Educational Packet: The patient will receive an educational packet. Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of participants who are insured | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Daytime Ambulatory Systolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | Data for this outcome measure were not collected for 16 in the STOP Model arm and 25 in the Usual Care arm. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 6 months after enrollment |
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| Secondary | Daytime Ambulatory Diastolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | Data for this outcome measure were not collected for 16 in the STOP Model arm and 25 in the Usual Care arm. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 6 months |
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| Secondary | Night Time Ambulatory Systolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | Data for this outcome measure were not collected for 16 in the STOP Model arm and 29 in the Usual Care arm. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 6 months |
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| Secondary | Nighttime Diastolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | Data for this outcome measure were not collected for 16 in the STOP Model arm and 29 in the Usual Care arm. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 6 months |
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| Secondary | Body Mass Index(BMI) | BMI will be calculated from height and weight. | Data for this outcome measure were not collected for 22 in the STOP Model arm and 29 in the Usual Care arm. | Posted | Mean | Standard Deviation | kilograms/meter^2 (kg/m^2) | 6 months |
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| Secondary | Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death) | Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Acute Healthcare Utilization | Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care. | Posted | Count of Participants | Participants | 6 months |
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| Other Pre-specified | Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire | Not Posted | 6 months | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS) | Not Posted | 6 months | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES) | Not Posted | 6 months | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES) | Not Posted | Baseline | Participants |
6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STOP Model | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is < 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment. | 1 | 42 | 4 | 27 | 1 | 27 |
| EG001 | Usual Care | Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet. Educational Packet: The patient will receive an educational packet. Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments | 0 | 41 | 2 | 17 | 2 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Hospitalization | General disorders | Systematic Assessment |
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| Hospitalization due to injury from fall | General disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Fall | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anjail Sharrief, MD, MPH, Associate Professor | The University of Texas Health Science Center at Houston | 713-500-6538 | anjail.z.sharrief@uth.tmc.edu |
| Oct 12, 2022 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2020 | May 3, 2022 | ICF_000.pdf |
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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