NCT01875094

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started Oct 2012

Typical duration for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

3.4 years

First QC Date

May 29, 2013

Last Update Submit

June 23, 2016

Conditions

StrokeHypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Medication Compliance

    3 months

  • Use of online tool

    3 months

Study Arms (2)

Self-Management / MTM via Health IT

EXPERIMENTAL

Stroke survivors are trained to measure and enter BP into an online health management tool

Other: Self-Management / MTM using Health IT

Usual Care

NO INTERVENTION

Interventions

Self-Management / MTM using Health ITOTHER
Self-Management / MTM via Health IT

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Stroke Survivors and their caregivers
  • English speaking
  • History of hypertension

You may not qualify if:

  • Cannot use the health-IT system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University_of_Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

  • 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.

    PMID: 29763657DERIVED

MeSH Terms

Conditions

StrokeHypertension

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 11, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations

US(1)