Self-Management in Stroke Survivors
Primary Purpose
Stroke, Hypertension
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Self-Management / MTM using Health IT
Sponsored by
About this trial
This is an interventional health services research trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Acute Stroke Survivors and their caregivers
- English speaking
- History of hypertension
Exclusion Criteria:
-Cannot use the health-IT system
Sites / Locations
- University_of_Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-Management / MTM via Health IT
Usual Care
Arm Description
Stroke survivors are trained to measure and enter BP into an online health management tool
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01875094
First Posted
May 29, 2013
Last Updated
June 23, 2016
Sponsor
University of Minnesota
Collaborators
Berman Center for Outcomes and Clinical Research, Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT01875094
Brief Title
Self-Management in Stroke Survivors
Official Title
Promoting Self-Management in Stroke Survivors Using Health IT
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Berman Center for Outcomes and Clinical Research, Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Management / MTM via Health IT
Arm Type
Experimental
Arm Description
Stroke survivors are trained to measure and enter BP into an online health management tool
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Self-Management / MTM using Health IT
Primary Outcome Measure Information:
Title
Rate of blood pressure control into guideline recommended ranges
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Medication Compliance
Description
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.
Time Frame
3 months
Title
Use of online tool
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute Stroke Survivors and their caregivers
English speaking
History of hypertension
Exclusion Criteria:
-Cannot use the health-IT system
Facility Information:
Facility Name
University_of_Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29763657
Citation
Lakshminarayan K, Westberg S, Northuis C, Fuller CC, Ikramuddin F, Ezzeddine M, Scherber J, Speedie S. A mHealth-based care model for improving hypertension control in stroke survivors: Pilot RCT. Contemp Clin Trials. 2018 Jul;70:24-34. doi: 10.1016/j.cct.2018.05.005. Epub 2018 May 12.
Results Reference
derived
Learn more about this trial
Self-Management in Stroke Survivors
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