Stroke, Acute Ischemic, Hypertension
Conditions
Keywords
Social Networks
Brief summary
This study aims to compare the efficacy of a social network intervention versus individual hypertension counseling to improve blood pressure control after stroke. The investigators hope to understand whether the involvement of family, friends and other members of individual's social network can help achieve better blood pressure after experiencing a stroke. Participants will be stratified to two groups according to network size (\<5 vs 5 or more) and randomized to receive individual hypertension counseling (control) or the social network intervention. The primary outcome of the study will be the absolute reduction in systolic blood pressure at 3 months follow-up. The secondary outcomes will be attainment of a post-stroke hypertension treatment goal and patient-reported physical function.
Interventions
OTHERSocial Network Group Counseling
Researchers will identify the influential network members based on their network position, driving distance from the patient, speaking frequency, and whether they have high blood pressure. The index patient and social network members will meet with the study nurse on weeks 2, 6, and 12 after initial enrollment. The study nurse will begin the social network counseling session in which she will provide counseling on teamwork and blood pressure control. The teamwork specific topics will include how networks can work together as a team, communication tips for engaging with one another, spreading positive messages, and establishing the roles and responsibilities of each network team member. The blood pressure control specific topics will include the basics of blood pressure, taking and adjusting medications, monitoring blood pressure, reducing salt, and being physically active. Patient and social network members will receive text messages every week in the weeks between sessions.
The index patient will meet individually with the study nurse on weeks 2, 6, and 12 after initial enrollment. The nurse will provide counseling on the basics of blood pressure, taking and adjusting medications, monitoring blood pressure, reducing salt, and being physically active. The patient will receive text messages every week in the weeks between sessions.
Sponsors
National Institute on Aging (NIA)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. First acute ischemic stroke defined clinically with support from imaging if necessary 2. 21 years of age or older 3. Within 14 days after stroke 4. History of hypertension or has been newly prescribed blood pressure medications during index admission
Exclusion criteria
1. Prior ischemic or hemorrhagic stroke 2. NIHSS \> 21 3. Significant aphasia (Score\>1 on the language section of the NIHSS) 4. Medical conditions for which death is likely within 6 months 5. Does not have capacity to consent for the project or participate in survey interview 6. Diagnosis of dementia 7. Patient has no phone or incapable of using text messages 8. Patient has opted out of participating in research noted within MGB Epic EHR system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure for Patient-Subjects | baseline and 3 months | Blood pressure was not collected for social network members. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects | 3 months | This was evaluated as achieving a blood pressure of \<130/80 mmHg. Blood pressure was not collected for social network members. |
| Patient Reported Physical Function for Patient-Subjets | 3 months | This was evaluated for patient-subjects only (not collected for social network subjects), using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) scale. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. The T-score is provided with an error term (Standard Error or SE). The Standard Error is a statistical measure of variance and represents the margin of error for the T-score. A higher PROMIS T-score represents better physical function. A T-score of 60 indicates one SD better than the average physical function for the United States general population. |
Countries
United States
Participant flow
Pre-assignment details
A total of 47 patients enrolled, but 2 patients withdrew prior to randomization. Social network members were only enrolled in the social network counseling arm. All consented patients' social network members were collected in the baseline questionnaire, prior to randomization. For patients who were randomized to individual counseling (n=21), network members were not enrolled. For patients who were randomized to social network counseling (n=24), network members were enrolled (n=17).
Participants by arm
| Arm | Count |
|---|---|
| Social Network Counseling - Patients Only The index patient and influential social network members will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for teamwork counseling and blood pressure education.
Social Network Group Counseling: Researchers will identify the influential network members based on their network position, driving distance from the patient, speaking frequency, and whether they have high blood pressure. The index patient and social network members will meet with the study nurse on weeks 2, 6, and 12 after initial enrollment. The study nurse will begin the social network counseling session in which she will provide counseling on teamwork and blood pressure control. The teamwork specific topics will include how networks can work together as a team, communication tips for engaging with one another, spreading positive messages, and establishing the roles and responsibilities of each network team member. The blood pressure control specific topics will include the basics of blood pressure, taking and adjusting medications, monitoring blood pressure, reducing salt, and being physically active. Patient and social network members will receive text messages every week in the weeks between sessions. | 24 |
| Individual Counseling - Patients Only The index patient will meet via Zoom 3 times over the course of 3 months with a clinical research nurse for blood pressure education.
Individual Counseling: The index patient will meet individually with the study nurse on weeks 2, 6, and 12 after initial enrollment. The nurse will provide counseling on the basics of blood pressure, taking and adjusting medications, monitoring blood pressure, reducing salt, and being physically active. The patient will receive text messages every week in the weeks between sessions. | 21 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient lost to follow-up | 10 | 3 |
| Overall Study | Patient withdrawal | 6 | 7 |
| Overall Study | Social network member lost to follow-up | 5 | 0 |
| Overall Study | Social network member withdrawal | 1 | 0 |
Baseline characteristics
| Characteristic | Social Network Counseling - Patients Only | Individual Counseling - Patients Only | Total |
|---|---|---|---|
| Age, Continuous | 64.41 years STANDARD_DEVIATION 13.46 | 70.71 years STANDARD_DEVIATION 10.41 | 67.36 years STANDARD_DEVIATION 12.28 |
| Baseline Systolic Blood Pressure | 135.32 mmHg STANDARD_DEVIATION 21.74 | 145.81 mmHg STANDARD_DEVIATION 21.05 | 140.44 mmHg STANDARD_DEVIATION 21.55 |
| Education level Associate degree | 2 Participants | 2 Participants | 4 Participants |
| Education level Bachelor's degree | 5 Participants | 4 Participants | 9 Participants |
| Education level Graduate degree | 6 Participants | 3 Participants | 9 Participants |
| Education level High school graduate | 4 Participants | 7 Participants | 11 Participants |
| Education level Prefer not to answer | 1 Participants | 0 Participants | 1 Participants |
| Education level Some college | 4 Participants | 5 Participants | 9 Participants |
| Education level Some high school or less | 2 Participants | 0 Participants | 2 Participants |
| Employment status Employed | 9 Participants | 7 Participants | 16 Participants |
| Employment status Other | 4 Participants | 1 Participants | 5 Participants |
| Employment status Retired | 9 Participants | 9 Participants | 18 Participants |
| Employment status Self-employed | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity Hisapnic/Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity Not Hispanic/Latino | 22 Participants | 18 Participants | 40 Participants |
| Ethnicity Unknown | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Married | 11 Participants | 10 Participants | 21 Participants |
| Marital Status Not married | 13 Participants | 11 Participants | 24 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 7 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
| Social network size | 4.92 Network members STANDARD_DEVIATION 3.24 | 5.86 Network members STANDARD_DEVIATION 4.45 | 5.36 Network members STANDARD_DEVIATION 3.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 0 / 24 | 0 / 21 |
| serious Total, serious adverse events | 1 / 24 | 2 / 21 |
Outcome results
Primary
Change in Systolic Blood Pressure for Patient-Subjects
Blood pressure was not collected for social network members.
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Network Counseling | Change in Systolic Blood Pressure for Patient-Subjects | -10.82 mmHg | Standard Deviation 5.08 |
| Individual Counseling | Change in Systolic Blood Pressure for Patient-Subjects | -5.31 mmHg | Standard Deviation 6.1 |
Secondary
Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects
This was evaluated as achieving a blood pressure of \<130/80 mmHg. Blood pressure was not collected for social network members.
Time frame: 3 months
Population: This was only assessed for those patient subjects who completed the 3-month follow-up period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Social Network Counseling | Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects | 5 Participants |
| Individual Counseling | Achievement of Post-stroke Hypertension Treatment Goal for Patient-Subjects | 3 Participants |
Secondary
Patient Reported Physical Function for Patient-Subjets
This was evaluated for patient-subjects only (not collected for social network subjects), using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) scale. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. The T-score is provided with an error term (Standard Error or SE). The Standard Error is a statistical measure of variance and represents the margin of error for the T-score. A higher PROMIS T-score represents better physical function. A T-score of 60 indicates one SD better than the average physical function for the United States general population.
Time frame: 3 months
Population: This was only assessed for those patient-subjects who completed the 3-month follow-up period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Network Counseling | Patient Reported Physical Function for Patient-Subjets | 37.48 T-score on a scale | Standard Deviation 12.88 |
| Individual Counseling | Patient Reported Physical Function for Patient-Subjets | 45.25 T-score on a scale | Standard Deviation 12.2 |