Self-Management in Stroke Survivors

Stroke Clinical Trial

Official title:

Promoting Self-Management in Stroke Survivors Using Health IT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875094
• Other study ID #: 1212M25581
• Secondary ID: R21HS021794
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 29, 2013
• Last updated: June 23, 2016
• Start date: October 2012
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Acute Stroke Survivors and their caregivers

• English speaking

• History of hypertension

Exclusion Criteria:

-Cannot use the health-IT system

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension
• Stroke

Intervention

Other:
• Self-Management / MTM using Health IT

Locations

Country	Name	City	State
United States	University_of_Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Agency for Healthcare Research and Quality (AHRQ), Berman Center for Outcomes and Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of blood pressure control into guideline recommended ranges	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.	3 months	No
Secondary	Medication Compliance	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.	3 months	No
Secondary	Use of online tool	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.	3 months	No