Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730465
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-01-27
Brief Title:
Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn whether providing teaching with a low-cost device can help to improve blood pressure health outcomes patient self-efficacy without exacerbating inequity between advantaged and disadvantaged patients
The main questions it aims to answer are
1 Does providing a free home blood pressure cuff improve control of hypertension
2 Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations
3 Does improved control of home blood pressure decrease adverse patient outcomes
Participants will be asked to
Take their blood pressure at home and records the results
Participate in follow-up phone calls from investigators at at 3 and 6 months
Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education
The main questions it aims to answer are
1 Does providing a free home blood pressure cuff improve control of hypertension
2 Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations
3 Does improved control of home blood pressure decrease adverse patient outcomes
Participants will be asked to
Take their blood pressure at home and records the results
Participate in follow-up phone calls from investigators at at 3 and 6 months
Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education
Detailed Description:
Patients with a history of hypertension and a history stroke ischemic or hemorrhagic transient ischemic attack TIA or otherwise are at high risk of stroke will be screened for enrollment
Inclusion and exclusion criteria will be reviewed and confirmed by a member of the study team If the patient meets criteria the following will occur
A member of the study team physician nurse study coordinator will describe the study to the patient and inform them of their candidacy If the patient indicates interest in study participation the patient will be provided a written or electronic consent form to review and sign The patient will be randomized to one of two arms in the study
Upon enrollment the patient will complete an intake survey Prior to hospital discharge patients randomized to arm 1 control of the study will receive routine stroke discharge education which is standard of care In addition to standard of care a stroke nurse will provide and review with the patient a short informational pamphlet included in the attachments on the importance of blood pressure monitoring
Patients randomized to arm 2 intervention will also receive this teaching as above In addition they will be given an Omron Home Blood Pressure Cuff furnished by the study The nurse will provide additional education on on how to use the cuff and how to record values in a blood pressure log
At three months following enrollment a member of the study team will call the patients in both arms to complete a questionnaire included in the attachments over the phone and provide a blood pressure reading using their home blood pressure cuff If needed a phone interpreter will be used
At three months patients randomized to arm 1 of the study will receive a blood pressure cuff in the mail with written instructions on how to use it
At six months following enrollment a member of the study team will call the patients in both arms to complete a questionnaire over the phone and provide a blood pressure reading using their home blood pressure cuff If needed a phone interpreter will be used
The patient will be notified that the duration of their participation in the study has ended All study materials given to the patient are theirs to keep
A chart review will be conducted for the study participants to supply information about health outcomes incurred throughout the duration of the study and to obtain blood pressure readings from ambulatory visits
Inclusion and exclusion criteria will be reviewed and confirmed by a member of the study team If the patient meets criteria the following will occur
A member of the study team physician nurse study coordinator will describe the study to the patient and inform them of their candidacy If the patient indicates interest in study participation the patient will be provided a written or electronic consent form to review and sign The patient will be randomized to one of two arms in the study
Upon enrollment the patient will complete an intake survey Prior to hospital discharge patients randomized to arm 1 control of the study will receive routine stroke discharge education which is standard of care In addition to standard of care a stroke nurse will provide and review with the patient a short informational pamphlet included in the attachments on the importance of blood pressure monitoring
Patients randomized to arm 2 intervention will also receive this teaching as above In addition they will be given an Omron Home Blood Pressure Cuff furnished by the study The nurse will provide additional education on on how to use the cuff and how to record values in a blood pressure log
At three months following enrollment a member of the study team will call the patients in both arms to complete a questionnaire included in the attachments over the phone and provide a blood pressure reading using their home blood pressure cuff If needed a phone interpreter will be used
At three months patients randomized to arm 1 of the study will receive a blood pressure cuff in the mail with written instructions on how to use it
At six months following enrollment a member of the study team will call the patients in both arms to complete a questionnaire over the phone and provide a blood pressure reading using their home blood pressure cuff If needed a phone interpreter will be used
The patient will be notified that the duration of their participation in the study has ended All study materials given to the patient are theirs to keep
A chart review will be conducted for the study participants to supply information about health outcomes incurred throughout the duration of the study and to obtain blood pressure readings from ambulatory visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None