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Self-Management in Stroke Survivors

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ClinicalTrials.gov Identifier: NCT01875094
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : June 24, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.

Condition or disease Intervention/treatment Phase
Stroke Hypertension Other: Self-Management / MTM using Health IT Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Promoting Self-Management in Stroke Survivors Using Health IT
Study Start Date : October 2012
Primary Completion Date : March 2016
Study Completion Date : March 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: Self-Management / MTM via Health IT
Stroke survivors are trained to measure and enter BP into an online health management tool
Other: Self-Management / MTM using Health IT
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures :
  1. Rate of blood pressure control into guideline recommended ranges [ Time Frame: 3 months ]
    The American Heart Association/American Stroke Association (AHA/ASA) have cited the JNC-7 in their guidelines to define normal blood pressure as < 120/80. We will use these guidelines and examine rates (percentage of subjects) of blood pressure control in intervention vs. usual care group.

Secondary Outcome Measures :
  1. Medication Compliance [ Time Frame: 3 months ]
    Percent of subjects who have discontinued one or more of the blood pressure medications on their own (i.e. without medical direction) in the intervention vs. usual care group.

  2. Use of online tool [ Time Frame: 3 months ]
    Ease of online health management tool use will be operationalized as the percent of subjects in the intervention group who measure their BP and enter it online at least 75% of the study period, 50% of the study period and those with 25% or less of the study period.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute Stroke Survivors and their caregivers
  • English speaking
  • History of hypertension

Exclusion Criteria:

-Cannot use the health-IT system

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875094

United States, Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Berman Center for Outcomes and Clinical Research
Agency for Healthcare Research and Quality (AHRQ)
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01875094     History of Changes
Other Study ID Numbers: 1212M25581
R21HS021794 ( U.S. AHRQ Grant/Contract )
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases