Self-Management in Stroke Survivors

This study is currently recruiting participants.
Verified October 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Berman Center for Outcomes and Clinical Research
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01875094
First received: May 29, 2013
Last updated: October 17, 2013
Last verified: October 2013
  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 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 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01875094

Locations
United States, Minnesota
University_of_Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Kamakshi Lakshminarayan    612-624-9492    kamakshi@umn.edu   
Principal Investigator: Kamakshi Lakshminarayan, MD PhD         
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
ClinicalTrials.gov Identifier: NCT01875094     History of Changes
Other Study ID Numbers: 1212M25581, R21HS021794
Study First Received: May 29, 2013
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014