StrokePhase 1/2NCT01875094
Self-Management in Stroke Survivors
A Phase 1/2 study testing Self-Management / MTM using Health IT in people with Stroke and Hypertension, run by University of Minnesota at 1 site in United States.
Trial summary
This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Hypertension
- What is being tested?
- Self-Management / MTM using Health IT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Stroke Survivors and their caregivers
- English speaking
- History of hypertension
Who cannot join
- -Cannot use the health-IT system
Trial locations and contacts
1 site in 1 country.
United States1 site
University_of_Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Promoting Self-Management in Stroke Survivors Using Health IT
This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.
- Conditions
- Stroke, Hypertension
- Being tested
- Self-Management / MTM using Health IT
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management / MTM using Health ITOther
| Study group | Role | What they receive |
|---|---|---|
| Self-Management / MTM via Health IT | Experimental | Stroke survivors are trained to measure and enter BP into an online health management tool Receives: Other: Self-Management / MTM using Health IT |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Berman Center for Outcomes and Clinical Research, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875094
- Sponsor's protocol ID
- 1212M25581
- Other IDs
- R21HS021794
- Status last verified
- Jun 2016
- First submitted
- 29 May 2013
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29763657
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Self-Management in Stroke Survivors Using Health IT
- ClinicalTrials.gov ID
- NCT01875094
- Acronym / sponsor ID
- 1212M25581
- Conditions
- Stroke, Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Berman Center for Outcomes and Clinical Research, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Oct 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management / MTM via Health IT | Experimental | Other: Self-Management / MTM using Health ITStroke survivors are trained to measure and enter BP into an online health management tool |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute Stroke Survivors and their caregivers
- English speaking
- History of hypertension
Key exclusion criteria (1 listed)
- -Cannot use the health-IT system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Management / MTM using Health IT | Other | Self-Management / MTM via Health IT |
Primary outcome
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.
2 secondary outcomes
Medication Compliance
Time frame: 3 months
Use of online tool
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 29763657Lakshminarayan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Self-Management / MTM using Health IT in people with Stroke and Hypertension, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of blood pressure control into guideline recommended ranges (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.