A Behavioral Intervention To Improve Hypertension Control In Veterans
8. Mai 2015 aktualisiert von: US Department of Veterans Affairs
A Behavioral Intervention to Improve Hypertension Control in Veterans
The purpose of this study is to determine whether a stage-matched intervention (SMI) will lower BP and improve treatment adherence compared to usual care (UC) or a health education intervention (HEI) in veterans with uncontrolled BP.
The study will also examine the effect of SMI on patient's health-related quality of life, satisfaction, acceptability and determine its cost-effectiveness.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
We propose a randomized controlled trial to evaluate the effect of telephone-delivered interventions (SMI and HEI) to improve BP control.
Veterans with uncontrolled hypertension (n=533) will be randomized equally to 3 groups: 1) The SMI will use the Transtheoretical model (TTM) as the unifying framework. Veterans will receive TTM stage-matched counseling for exercise, diet, and medications via monthly counseling sessions. A social worker (SW) will assess each participant's behavior and deliver the appropriate tailored SMI based on their stage of change, decisional balance, self-efficacy and the skills model questions. 2) The HEI group receives monthly telephone calls by a SW during which they will receive education about hypertension management. 3) The UC group participates in all the in-person visits but does not receive monthly calls.
There will be an initial 6-month active intervention phase followed by a 6 month monitoring phase to assess sustainability. All participants will visit the VAMC's at baseline and at 3, 6, and 12 months. Outcomes of interest include BP; adherence (to diet, exercise and medications); quality of life; satisfaction; acceptability; cost and cost-effectiveness. Patients will be blinded to which of the intervention arms (SMI or HEI) they are in, SW's will be blinded to patient's BP and staff measuring outcomes will be blinded to study assignment. The study will be analyzed using longitudinal data analysis methods using an intention to treat strategy.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
533
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
New York
-
New York, New York, Vereinigte Staaten, 10010
- VA New York Harbor Health Care System
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Patients receiving continuity of care in the outpatient clinics will be eligible. This will be operationalized as 2 visits in the previous year.
- Adults (= 21 years) with hypertension, on antihypertensive medication for = 1 year, and who have current uncontrolled BP will be enrolled.
Patients with CVD:
- chronic stable angina
- unstable angina
- uncomplicated myocardial infarction
- coronary artery bypass surgery
- percutaneous coronary angioplasty
- atherectomy or stent placement
- chronic stable angina pectoris
- stable Class I or Class II congestive heart failure
- stroke
- peripheral vascular disease
will be entered into the study if the CVD event or diagnosis occurred = 6 months ago.
Exclusion Criteria:
Patients with limited life expectancy (< 1 year) due to severe co-existing non-CVD disease such as:
- terminal illnesses such as terminal cancer
- CVD < 6 months ago
- Class III or IV CHF
- severe psychiatric illness such as psychosis
- manic depression
- alcohol abuse (> 21 drinks/week)
- serious chronic conditions like AIDS
- tuberculosis
- lupus
- and end-stage renal failure
will be excluded.
- Other exclusions include inability to understand English
- Lack of a landline telephone
- Unable to follow the study protocol
- Recent major surgery (< 3 months)
- Patients who are temporarily in the area and plan to move in < 1 year or will not be available for follow-up
- Those unable to provide informed consent.
- All patients excluded and reason for exclusion will be recorded.
- Prior to recruitment, each patient will be informed about the study and informed consent obtained.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Stage-matched intervention (SMI)
|
Stage-matched intervention
Health Education Intervention
Usual Care
|
|
Aktiver Komparator: Health Education Intervention (HEI)
|
Stage-matched intervention
Health Education Intervention
Usual Care
|
|
Kein Eingriff: Usual Care (UC)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Blood Pressure Control
Zeitfenster: 6 months
|
Blood pressure Control at 6 months
|
6 months
|
|
Systolic Blood Pressure
Zeitfenster: 6 months
|
Mean systolic Blood Pressure
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Proportion With BP Under Control From Baseline to 6 Months
Zeitfenster: 6 months
|
6 months
|
|
|
Change in Systolic Blood Pressure From Baseline to 6 Months
Zeitfenster: Baseline and 6 months
|
Baseline and 6 months
|
|
|
Change in Number of Cardio Exercise Hours From Baseline to 6 Months
Zeitfenster: baseline and 6 months
|
baseline and 6 months
|
|
|
Change in Morisky Score From Baseline to 6 Months
Zeitfenster: baseline and 6 months
|
Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4.
A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent
|
baseline and 6 months
|
|
Diet Stage of Change
Zeitfenster: 6 months
|
The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months.
Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.
|
6 months
|
|
Exercise Stage of Change
Zeitfenster: 6 months
|
The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months.
Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time.
We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.
|
6 months
|
|
Medication Stage of Change
Zeitfenster: 6 months
|
The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months.
Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.
|
6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Sundar Natarajan, MD MSc, VA New York Harbor Health Care System
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Ulmer M, Robinaugh D, Friedberg JP, Lipsitz SR, Natarajan S. Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention. Contemp Clin Trials. 2008 Sep;29(5):705-10. doi: 10.1016/j.cct.2008.04.005. Epub 2008 May 6.
- Friedberg JP, Lipsitz SR, Natarajan S. Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns. 2010 Jan;78(1):5-11. doi: 10.1016/j.pec.2009.04.009. Epub 2009 Jun 13.
- Friedberg JP, Rodriguez MA, Watsula ME, Lin I, Wylie-Rosett J, Allegrante JP, Lipsitz SR, Natarajan S. Effectiveness of a tailored behavioral intervention to improve hypertension control: primary outcomes of a randomized controlled trial. Hypertension. 2015 Feb;65(2):440-6. doi: 10.1161/HYPERTENSIONAHA.114.03483. Epub 2014 Nov 17.
- Rodriguez MA, Wang B, Hyoung S, Friedberg J, Wylie-Rosett J, Fang Y, Allegrante JP, Lipsitz SR, Natarajan S. Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial. Hypertension. 2021 Jun;77(6):1867-1876. doi: 10.1161/HYPERTENSIONAHA.120.15192. Epub 2021 May 12.
Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn
1. Juli 2006
Primärer Abschluss (Tatsächlich)
1. Januar 2010
Studienabschluss (Tatsächlich)
1. September 2011
Studienanmeldedaten
Zuerst eingereicht
1. Februar 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Februar 2006
Zuerst gepostet (Schätzen)
3. Februar 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
1. Juni 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Mai 2015
Zuletzt verifiziert
1. Mai 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IIR 04-170
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