- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01122394
Reducing Risk of Recurrence (RRR)
26. august 2016 opdateret af: VA Office of Research and Development
Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP.
Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause.
Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice.
We will determine whether a telephone-delivered behaviorally tailored intervention (TI) can lead to sustained change resulting in (a) BP and lipid control and (b) improved adherence to diet, medication, and exercise recommendations in veterans with a history of stroke or TIA compared to an attention placebo (AP) in veterans who have completed 6 months of a clinical trial.
In this CDA project, we evaluate the long-term effectiveness of booster sessions in a randomized manner.
One arm will receive 6 months of a tailored intervention (TI) followed by two booster TI sessions at 8 and 10 months, and one arm will receive 6 months of an attention placebo (AP) followed by two booster AP sessions at 8 and 10 months.
BP (3 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10010
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tailored Intervention (TI)
Tailored intervention based on the transtheoretical model
|
Tailored intervention based on the transtheoretical model
|
|
Placebo komparator: Attention Placebo (AP)
Attention Placebo
|
Attention placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Systolic Blood Pressure
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dietary Sodium
Tidsramme: 6 months
|
self-reported stage of change for adherence to DASH (low-sodium) diet.
Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)
|
6 months
|
|
Total Cholesterol/High Density Lipoprotein Ratio
Tidsramme: 6 months
|
6 months
|
|
|
Exercise Adherence
Tidsramme: 6 months
|
Measured by 7-day Physical Activity Recall
|
6 months
|
|
Antihypertensive/ Lipid-lowering Medication Adherence
Tidsramme: 6 months
|
Measured by Morisky Medication taking questionnaire (self-reported).
Scores range from 0-4, with 0 being least adherent and 4 being most adherent
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jennifer P Friedberg, PhD, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2010
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
10. maj 2010
Først indsendt, der opfyldte QC-kriterier
10. maj 2010
Først opslået (Skøn)
13. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDP 09-414
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .