N/A
N=140
Reducing Risk of Recurrence
Stroke · TIA · Hypertension · Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01122394 ↗Enrolled (actual)
140
Serious AEs
2.1%
Results posted
Oct 2016
Primary outcome: Primary: Systolic Blood Pressure — 130.83; 133.67 mm Hg — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TI (Behavioral); AP (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure |
130.83; 133.67 | 0.29 |
| SECONDARY Dietary Sodium |
11; 18; 52; 52 | 0.25 |
| SECONDARY Total Cholesterol/High Density Lipoprotein Ratio |
3.47; 3.21 | 0.11 |
| SECONDARY Exercise Adherence |
2.50; 2.75 | 0.81 |
| SECONDARY Antihypertensive/ Lipid-lowering Medication Adherence |
3.58; 3.43 | 0.12 |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01122394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.