Self-Management in Stroke Survivors

This study is ongoing, but not recruiting participants.
Berman Center for Outcomes and Clinical Research
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: May 29, 2013
Last updated: September 18, 2014
Last verified: September 2014

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

Condition Intervention Phase
Other: Self-Management / MTM using Health IT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Promoting Self-Management in Stroke Survivors Using Health IT

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Rate of blood pressure control into guideline recommended ranges [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Medication Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Use of online tool [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT01875094     History of Changes
Other Study ID Numbers: 1212M25581, R21HS021794
Study First Received: May 29, 2013
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on May 21, 2015