Health Care Acceptability, Hypertension, Stroke
Conditions
Keywords
Telehealth, Blood Pressure (BP)
Brief summary
The Telehealth After Stroke Care (TASC) trial is a pilot randomized controlled trial. It aims to evaluate the feasibility of a telehealth based model providing multidisciplinary access including nursing, pharmacy and physician care, and obtain preliminary evidence of efficacy of an integrated telehealth approach to blood pressure management after stroke.
Detailed description
Hypertension is the most modifiable risk factor for recurrent stroke. Blood pressure (BP) reduction is associated with decreased risk of stroke recurrence but remains poorly controlled in most survivors. Minority groups have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) will be a telehealth intervention that integrates remote BP monitoring and telehealth visits to enhance BP control and promote self-efficacy, with a multidisciplinary approach to improve clinical processes and health outcomes. The investigators will assess for feasibility and obtain preliminary evidence of efficacy. Fifty (50) eligible patients will be screened for inclusion prior to hospital discharge and randomized to TASC or usual care. TASC patients will receive a BP monitoring kit and electronic tablet. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy at 4 and 8 weeks and stroke neurologist. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. Data will be collected at 0 and 3 months. The primary outcome will be BP control (BP \<140/90 mmHg) at 3 months. The secondary outcome will be self-efficacy in medication adherence and treatment. Interdisciplinary team competency, fidelity, and telehealth satisfaction surveys will be administered. Patient reported outcomes including depression, cognitive function, and socioeconomic determinants will also be collected. Integrated team-based interventions are needed to improve BP control and reduce racial disparities in post-stroke care. It may be feasible and effective in enhancing post-stroke BP control and promoting self-efficacy.
Interventions
OTHERUsual care
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
OTHERTASC intervention
TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Multidisciplinary Team Nursing: transitions of care, motivational interview w/ tailored infographics Pharmacy: medication education, adherence and titration Physician: patient tailored risk factor control, post stroke complications Integrated Approach: Home BP monitoring with remote support, Telehealth visits by each discipline, Tailored BP infographics, Patient Reported Outcomes (PROs)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions) * Plan for discharge home after stroke * Ability to provide consent (patient or caregiver)
Exclusion criteria
* Modified Rankin scale ≥ 4 at time of enrollment (severely disabled) * Pregnancy * Severe psychiatric illness * Dialysis or diagnosis of end stage renal disease * Life expectancy \< 1 year or terminal illness * Symptomatic flow limiting cerebrovascular stenosis without plan for intervention, or long-term BP goal ≥ 140/90
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Systolic BP Control | Up to 3 months | The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be \< 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants. |
| Percentage of Participants Who Completed at Least 1 Video Visit | 3 months | This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Percentage | 3 months | Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TASC Intervention TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. | 25 |
| TASC Control Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | TASC Intervention | TASC Control | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 15.6 | 62.6 years STANDARD_DEVIATION 12.4 | 64.3 years STANDARD_DEVIATION 14 |
| Diastolic Blood Pressure (DBP) | 80.2 mmHg STANDARD_DEVIATION 10.5 | 79.9 mmHg STANDARD_DEVIATION 11.8 | 80.1 mmHg STANDARD_DEVIATION 11.1 |
| Race/Ethnicity, Customized Dominican / Hispanic | 14 Participants | 8 Participants | 22 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 6 Participants | 10 Participants | 16 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
| Systolic Blood Pressure (SBP) | 139.7 mmHg STANDARD_DEVIATION 18.9 | 142.0 mmHg STANDARD_DEVIATION 18.9 | 140.9 mmHg STANDARD_DEVIATION 18.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Percentage of Participants Who Completed at Least 1 Video Visit
This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation.
Time frame: 3 months
Population: Only data of evaluable participants were included in the analysis: 23 out of 25 TASC Intervention patients and 24 out of 25 TASC Control patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TASC Intervention | Percentage of Participants Who Completed at Least 1 Video Visit | 91 percentage of participants |
| TASC Control | Percentage of Participants Who Completed at Least 1 Video Visit | 75 percentage of participants |
Primary
Percentage of Participants With Systolic BP Control
The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be \< 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants.
Time frame: Up to 3 months
Population: Only data of evaluable participants were included in the analysis: 21 out of 25 TASC Intervention patients and 16 out of 25 TASC Control patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TASC Intervention | Percentage of Participants With Systolic BP Control | 76 percentage of participants |
| TASC Control | Percentage of Participants With Systolic BP Control | 25 percentage of participants |
Secondary
Medication Adherence Percentage
Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention.
Time frame: 3 months
Population: Only data of evaluable participants were included in the analysis: 21 out of 25 TASC Intervention patients and 16 out of 25 TASC Control patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TASC Intervention | Medication Adherence Percentage | 67 percentage of participants |
| TASC Control | Medication Adherence Percentage | 63 percentage of participants |