Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 9:53 AM
Study NCT ID:
NCT07414732
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
The "Savvy for Stroke Survivors" Study: Testing a Novel Tool to Help Stroke Survivors Take Their Medication
Status:
RECRUITING
Status Verified Date:
2026-03
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 study is to test if Savvy, a multimodal intervention (consisting of psychological exercises, a weekly pill organizer, and a text message reminder system) can improve medication adherence in stroke survivors.
The main questions it aims to answer are:
* Can the Savvy tool improve medication adherence in stroke survivors compared to usual care?
* Does the use of the Savvy tool lead to better blood pressure control after a stroke?
The investigators will compare the use of the Savvy intervention to a control group that receives usual care, including a package of educational materials.
The study consists of the following components:
* Participants will receive the Savvy intervention or usual care. The intervention package consists of short psychological exercises over the phone, a weekly medication organizer to support daily medication intake, and text message reminders to take medication and refill the medication box. Participants in the control group will receive usual care, including educational materials about the importance of blood pressure and medication.
* All participants will receive a free home blood pressure monitor and will be requested to measure their blood pressure at certain time points during the study.
* Participants will be enrolled in the study for 6 months and will have virtual follow-up calls at 3 and 6 months.
The main questions it aims to answer are:
* Can the Savvy tool improve medication adherence in stroke survivors compared to usual care?
* Does the use of the Savvy tool lead to better blood pressure control after a stroke?
The investigators will compare the use of the Savvy intervention to a control group that receives usual care, including a package of educational materials.
The study consists of the following components:
* Participants will receive the Savvy intervention or usual care. The intervention package consists of short psychological exercises over the phone, a weekly medication organizer to support daily medication intake, and text message reminders to take medication and refill the medication box. Participants in the control group will receive usual care, including educational materials about the importance of blood pressure and medication.
* All participants will receive a free home blood pressure monitor and will be requested to measure their blood pressure at certain time points during the study.
* Participants will be enrolled in the study for 6 months and will have virtual follow-up calls at 3 and 6 months.
Detailed Description:
The investigators will conduct a randomized controlled trial to evaluate the preliminary efficacy of the Savvy intervention, an intervention incorporating psychological strategies and practical tools to improve medication adherence and blood pressure control among stroke survivors.
A total of 150 stroke survivors will be enrolled and followed longitudinally for a duration of 6 months. Stratified randomization will be performed in a 1:1 ratio for the Savvy intervention and control group.
The intervention group will receive the Savvy intervention and a free BP monitor to support their medication intake. The control group will also receive the free BP monitor, as well as access to educational materials about blood pressure management. All participants will complete study assessments at baseline, and at 3 and 6 months of enrollment.
A total of 150 stroke survivors will be enrolled and followed longitudinally for a duration of 6 months. Stratified randomization will be performed in a 1:1 ratio for the Savvy intervention and control group.
The intervention group will receive the Savvy intervention and a free BP monitor to support their medication intake. The control group will also receive the free BP monitor, as well as access to educational materials about blood pressure management. All participants will complete study assessments at baseline, and at 3 and 6 months of enrollment.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: