Blood Pressure, Psychosocial Impairment, Stroke Prevention, Telemedicine
Conditions
Brief summary
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.
Interventions
BEHAVIORALEducational Packet
The patient will receive an educational packet.
BEHAVIORALPhone 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
BEHAVIORALTelehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge
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.
BEHAVIORALEducational messages every other week
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
DIAGNOSTIC_TESTBP monitoring by QardioARM with periodic transmission of BP data
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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic and hemorrhagic stroke patients * Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH) * Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions) * Plan to discharge home after stroke * Ability to provide consent (patient or caregiver) * Ability to communicate in English
Exclusion criteria
* modified Rankin scale \> 4 at the time of enrollment (severe disability) * life expectancy \< 1 year or terminal illness, * eGFR \< 30 at time of discharge * pregnancy * symptomatic flow limiting carotid stenosis without plan for intervention * urine toxicology positive for cocaine or methamphetamine or recent use * long-term BP goal ≥ 130/80 mmHg according to clinical team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daytime Ambulatory Systolic Blood Pressure | 6 months after enrollment | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nighttime Diastolic Blood Pressure | 6 months | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). |
| Body Mass Index(BMI) | 6 months | BMI will be calculated from height and weight. |
| Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death) | 6 months | Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death. |
| Number of Participants With Acute Healthcare Utilization | 6 months | Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care. |
| Daytime Ambulatory Diastolic Blood Pressure | 6 months | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). |
| Night Time Ambulatory Systolic Blood Pressure | 6 months | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). |
Other
| Measure | Time frame |
|---|---|
| Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES) | 6 months |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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 | 41 |
| Total | 83 |
Baseline characteristics
| Characteristic | STOP Model | Total | Usual Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 12 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 71 Participants | 36 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 11.6 | 54.5 years STANDARD_DEVIATION 10.9 | 53.4 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 20 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 62 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Number of participants who are insured | 13 Participants | 26 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 37 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) White | 13 Participants | 26 Participants | 13 Participants |
| Region of Enrollment United States | 42 Participants | 83 Participants | 41 Participants |
| Sex: Female, Male Female | 20 Participants | 43 Participants | 23 Participants |
| Sex: Female, Male Male | 22 Participants | 40 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 42 | 0 / 41 |
| other Total, other adverse events | 1 / 27 | 2 / 17 |
| serious Total, serious adverse events | 4 / 27 | 2 / 17 |
Outcome results
Primary
Daytime Ambulatory Systolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time frame: 6 months after enrollment
Population: Data for this outcome measure were not collected for 16 in the STOP Model arm and 25 in the Usual Care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STOP Model | Daytime Ambulatory Systolic Blood Pressure | 123.6 millimeters of mercury (mmHg) | Standard Deviation 16.7 |
| Usual Care | Daytime Ambulatory Systolic Blood Pressure | 128.3 millimeters of mercury (mmHg) | Standard Deviation 19.7 |
Secondary
Body Mass Index(BMI)
BMI will be calculated from height and weight.
Time frame: 6 months
Population: Data for this outcome measure were not collected for 22 in the STOP Model arm and 29 in the Usual Care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STOP Model | Body Mass Index(BMI) | 33.8 kilograms/meter^2 (kg/m^2) | Standard Deviation 7.4 |
| Usual Care | Body Mass Index(BMI) | 27.7 kilograms/meter^2 (kg/m^2) | Standard Deviation 3.9 |
Secondary
Daytime Ambulatory Diastolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time frame: 6 months
Population: Data for this outcome measure were not collected for 16 in the STOP Model arm and 25 in the Usual Care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STOP Model | Daytime Ambulatory Diastolic Blood Pressure | 75.1 millimeters of mercury (mmHg) | Standard Deviation 9.6 |
| Usual Care | Daytime Ambulatory Diastolic Blood Pressure | 76.5 millimeters of mercury (mmHg) | Standard Deviation 13.7 |
Secondary
Night Time Ambulatory Systolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time frame: 6 months
Population: Data for this outcome measure were not collected for 16 in the STOP Model arm and 29 in the Usual Care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STOP Model | Night Time Ambulatory Systolic Blood Pressure | 117.3 millimeters of mercury (mmHg) | Standard Deviation 16 |
| Usual Care | Night Time Ambulatory Systolic Blood Pressure | 119.3 millimeters of mercury (mmHg) | Standard Deviation 19.3 |
Secondary
Nighttime Diastolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time frame: 6 months
Population: Data for this outcome measure were not collected for 16 in the STOP Model arm and 29 in the Usual Care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STOP Model | Nighttime Diastolic Blood Pressure | 69.4 millimeters of mercury (mmHg) | Standard Deviation 8.9 |
| Usual Care | Nighttime Diastolic Blood Pressure | 68 millimeters of mercury (mmHg) | Standard Deviation 13.7 |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STOP Model | Number of Participants With Acute Healthcare Utilization | 2 Participants |
| Usual Care | Number of Participants With Acute Healthcare Utilization | 2 Participants |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STOP Model | Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death) | 3 Participants |
| Usual Care | Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death) | 2 Participants |
Other Pre-specified
Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire
Time frame: 6 months
Other Pre-specified
Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS)
Time frame: 6 months
Other Pre-specified
Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)
Time frame: 6 months
Other Pre-specified
Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)
Time frame: Baseline