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Self-Management in Stroke Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01875094
First Posted: June 11, 2013
Last Update Posted: June 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Berman Center for Outcomes and Clinical Research
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.

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

Study Type: Interventional
Study Design: 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

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 ]
    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 ]
    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 ]
    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.


Enrollment: 56
Study Start Date: October 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
United States, Minnesota
University_of_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 Submitted: May 29, 2013
First Posted: June 11, 2013
Last Update Posted: June 24, 2016
Last Verified: June 2016

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


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