Ischemic StrokeAVAIL IINCT01115660

Stroke Education Intervention Trial - Pilot

A study testing stroke education in people with Ischemic Stroke and Intracranial Hemorrhage, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objectives of the trial of a medication-coach program for patients with stroke or transient ischemic attack are to pilot test the study design, the intervention components and the data collection forms and refine them for a larger trial whose goal will be to improve long-term adherence to stroke prevention… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Ischemic Stroke, Intracranial Hemorrhage, Transient Ischemic Attack
What is being tested?: stroke education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Jun 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18
Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage
provide consent to participate

Who cannot join

discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital
homeless
non-English speakers
patient and proxy unable to participate in telephone conversation

Trial locations and contacts

1 site in 1 country.

United States1 site

WFUBMC
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol

Conditions: Ischemic Stroke, Intracranial Hemorrhage, Transient Ischemic Attack
Being tested: stroke education
Keywords: stroke, patient education, medication adherence
Medical subject headings: Ischemic Stroke, Intracranial Hemorrhages, Ischemic Attack, Transient, Stroke, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stroke educationBehavioural
call by medication coach 2 weeks after hospital discharge

Study groups in NCT01115660
Study group	Role	What they receive
stroke education	Experimental	Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen. Receives: Behavioral: stroke education
control arm	No intervention	Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Intervention (Ability to Reach Patients at 3 Months)
Number of patients contacted at 3 months
Measured: 3 months

Secondary outcomes (1)

Follow up Appointment With MD
Follow up appointment with primary care provider since stroke
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Jun 2011

First posted4 May 2010 (estimated)
Study startJan 2010
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01115660
Sponsor's protocol ID: Pro00019690
Other IDs: 5U18HS016964
Acronym: AVAIL II
Status last verified: Dec 2012
First submitted: 2 May 2010
Last updated: 14 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sides EG, Zimmer LO, Wilson L, Pan W, Olson DM, Peterson ED, Bushnell C. Medication coaching program for patients with minor stroke or TIA: a pilot study. BMC Public Health. 2012 Jul 25;12:549. doi: 10.1186/1471-2458-12-549.
PubMed 22830539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol
ClinicalTrials.gov ID: NCT01115660
Acronym / sponsor ID: AVAIL II / Pro00019690
Conditions: Ischemic Stroke, Intracranial Hemorrhage, Transient Ischemic Attack
Keywords: stroke, patient education, medication adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Wake Forest University Health Sciences
Study start: Jan 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 4 May 2010 (estimated)
Results: Posted 24 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
stroke education	Experimental	Behavioral: stroke educationPatients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
control arm	No intervention	–Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18
Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage
provide consent to participate

Key exclusion criteria (4 listed)

discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital
homeless
non-English speakers
patient and proxy unable to participate in telephone conversation

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
stroke educationcall by medication coach 2 weeks after hospital discharge	Behavioural	stroke education

Primary outcome

Feasibility of Intervention (Ability to Reach Patients at 3 Months)
Time frame: 3 months
Number of patients contacted at 3 months

1 secondary outcome

Follow up Appointment With MD
Time frame: 3 months

Results and safety

Results posted to the registry on 24 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stroke Education	20	19
Control Arm	10	10

Primary outcome: Feasibility of Intervention (Ability to Reach Patients at 3 Months)

Time frame: 3 months. Number. Unit: number of patients contacted

Measure	Stroke Education n = 19	Control n = 10
Value	16	10

Population analysed: All eligible patients who also were available at 3 months for post-intervention follow-up call.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were not collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stroke Education	0 of 0	0 of 0	Not reported
Control Arm	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Adverse events not collected

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22830539Sides EG, Zimmer LO, Wilson L, Pan W, Olson DM, Peterson ED, Bushnell C. Medication coaching program for patients with minor stroke or TIA: a pilot study. BMC Public Health. 2012 Jul 25;12:549. doi: 10.1186/1471-2458-12-549.

Related trials for Ischemic Stroke

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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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RecruitingPhase 3
A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
Acute Ischemic Stroke

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.

Eric D Peterson, MD, MPH principal investigator

DCRI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing stroke education in people with Ischemic Stroke and Intracranial Hemorrhage, run by Duke University 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 4 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 14 Oct 2015. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Intervention (Ability to Reach Patients at 3 Months) (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 NCT01115660, 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 14 Oct 2015.