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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group will receive access to educational materials about the importance of blood pressure control and medication adherence, along with a home blood pressure monitor. | |
| Savvy Group | Experimental | The intervention group will receive the Savvy intervention to support medication adherence, consisting of psychological exercises, a weekly pill organizer, and a text messaging reminder system. Additionally, the intervention group will receive the same educational materials and home blood pressure monitor as the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Savvy Medication Adherence Intervention | Behavioral | The intervention group will receive the Savvy intervention to support medication adherence, consisting of psychological exercises, a weekly pill organizer, and a text messaging reminder system. Additionally, the intervention group will receive the same educational materials and home blood pressure monitor as the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Medication Adherence | The primary outcome is self-reported medication adherence using the validated Medication Adherence Report Scale (MARS-5). The MARS-5 scores ranges from 5-25; higher scores indicate better adherence. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Improvement | Defined as the proportion of patients who achieved a 10-mmHg reduction in systolic blood pressure | 3 and 6 months |
| Blood pressure control | The proportion of participants achieving a blood pressure of <130/80mmHg |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjula Singh, MD PhD | Contact | 6177265358 | SSINGH32@mgh.harvard.edu | |
| Evy Reinders, MD | Contact | ereinders@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sanjula Singh, MD PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Active, not recruiting | Boston | Massachusetts | 02114 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21896153 | Background | Arima H, Chalmers J. PROGRESS: Prevention of Recurrent Stroke. J Clin Hypertens (Greenwich). 2011 Sep;13(9):693-702. doi: 10.1111/j.1751-7176.2011.00530.x. Epub 2011 Sep 2. | |
| 34024117 | Background | Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available. |
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|
| 3 and 6 months |
| Self-Reported Medication Adherence at 3 months | Self-reported medication adherence measured using the Medication Adherence Report Scale (MARS-5) at 3 months. Scores range from 5-25; higher scores indicate better adherence. | 3 months |
| Massachusetts General Hospital |
| Recruiting |
| Boston |
| Massachusetts |
| 02114 |
| United States |
|
| 24490648 | Background | Harris PR, Brearley I, Sheeran P, Barker M, Klein WM, Creswell JD, Levine JM, Bond R. Combining self-affirmation with implementation intentions to promote fruit and vegetable consumption. Health Psychol. 2014 Jul;33(7):729-36. doi: 10.1037/hea0000065. Epub 2014 Feb 3. |
| 30006474 | Background | Nolan RP, Feldman R, Dawes M, Kaczorowski J, Lynn H, Barr SI, MacPhail C, Thomas S, Goodman J, Eysenbach G, Liu S, Tanaka R, Surikova J. Randomized Controlled Trial of E-Counseling for Hypertension: REACH. Circ Cardiovasc Qual Outcomes. 2018 Jul;11(7):e004420. doi: 10.1161/CIRCOUTCOMES.117.004420. |
| 27371106 | Background | Wan LH, Zhang XP, Mo MM, Xiong XN, Ou CL, You LM, Chen SX, Zhang M. Effectiveness of Goal-Setting Telephone Follow-Up on Health Behaviors of Patients with Ischemic Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2016 Sep;25(9):2259-70. doi: 10.1016/j.jstrokecerebrovasdis.2016.05.010. Epub 2016 Jun 28. |
| 22269592 | Background | Ogedegbe GO, Boutin-Foster C, Wells MT, Allegrante JP, Isen AM, Jobe JB, Charlson ME. A randomized controlled trial of positive-affect intervention and medication adherence in hypertensive African Americans. Arch Intern Med. 2012 Feb 27;172(4):322-6. doi: 10.1001/archinternmed.2011.1307. Epub 2012 Jan 23. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002543 | Cerebral Hemorrhage |
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002545 | Brain Ischemia |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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