NCT01122394

Brief Summary

Adults who have had a previous stroke or transient ischemic attack (TIA) remain at risk for having a second serious event, especially if they have uncontrolled blood pressure or cholesterol. However, many patients have difficulty following treatment recommendations for lowering blood pressure and cholesterol. The purpose of this research project is to evaluate the effect of 2 booster sessions of an educational counseling intervention on how well adults who have already participated in a 6-month clinical trial had a stroke or transient ischemic attack (TIA) are able to follow a treatment plan and control their blood pressure and cholesterol levels. We will also examine how effective this intervention is in improving adherence to diet, medication, and physical activity recommendations for adults who have had a prior stroke or TIA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable 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

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 20, 2016

Completed
Last Updated

October 20, 2016

Status Verified

August 1, 2016

Enrollment Period

5.4 years

First QC Date

May 10, 2010

Results QC Date

July 15, 2016

Last Update Submit

August 26, 2016

Conditions

StrokeTIAHypertensionHyperlipidemia

Keywords

strokerecurrenceblood pressureprevention

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    6 months

Secondary Outcomes (4)

  • Dietary Sodium

    6 months

  • Total Cholesterol/High Density Lipoprotein Ratio

    6 months

  • Exercise Adherence

    6 months

  • Antihypertensive/ Lipid-lowering Medication Adherence

    6 months

Study Arms (2)

Tailored Intervention (TI)

EXPERIMENTAL

Tailored intervention based on the transtheoretical model

Behavioral: TI

Attention Placebo (AP)

PLACEBO COMPARATOR

Attention Placebo

Behavioral: AP

Interventions

TIBEHAVIORAL

Tailored intervention based on the transtheoretical model

Tailored Intervention (TI)
APBEHAVIORAL

Attention placebo

Attention Placebo (AP)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Well-documented history of stroke or TIA that occurred at least 3 months prior to enrollment;
  • Age 21 years or older;
  • Continuity of care in the VAMC primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year;
  • On hypertensive and/or lipid-lowering agents;
  • A score of \>16 on the Mini-Mental Status Exam;
  • ability to exercise (assessed by 6-minute walk or timed get up and go).

You may not qualify if:

  • Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer;
  • No telephone number at which patient can be reached;
  • Plans to relocate outside of the NYC area within the next 6 months;
  • Inability to communicate over the telephone due to severe cognitive impairment or aphasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

StrokeHypertensionHyperlipidemiasRecurrence

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jennifer Friedberg, Ph.D.
Organization
VA New York Harbor Healthcare System
jennifer.friedberg@va.gov
212-951-3314

Study Officials

  • Jennifer P Friedberg, PhD

    Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 13, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 20, 2016

Results First Posted

October 20, 2016

Record last verified: 2016-08

Locations

US(1)