A Behavioral Intervention To Improve Hypertension Control In Veterans
8 mai 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
533
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10010
- VA New York Harbor Health Care System
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Stage-matched intervention (SMI)
|
Stage-matched intervention
Health Education Intervention
Usual Care
|
|
Comparateur actif: Health Education Intervention (HEI)
|
Stage-matched intervention
Health Education Intervention
Usual Care
|
|
Aucune intervention: Usual Care (UC)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood Pressure Control
Délai: 6 months
|
Blood pressure Control at 6 months
|
6 months
|
|
Systolic Blood Pressure
Délai: 6 months
|
Mean systolic Blood Pressure
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Proportion With BP Under Control From Baseline to 6 Months
Délai: 6 months
|
6 months
|
|
|
Change in Systolic Blood Pressure From Baseline to 6 Months
Délai: Baseline and 6 months
|
Baseline and 6 months
|
|
|
Change in Number of Cardio Exercise Hours From Baseline to 6 Months
Délai: baseline and 6 months
|
baseline and 6 months
|
|
|
Change in Morisky Score From Baseline to 6 Months
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Sundar Natarajan, MD MSc, VA New York Harbor Health Care System
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2006
Achèvement primaire (Réel)
1 janvier 2010
Achèvement de l'étude (Réel)
1 septembre 2011
Dates d'inscription aux études
Première soumission
1 février 2006
Première soumission répondant aux critères de contrôle qualité
1 février 2006
Première publication (Estimation)
3 février 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 juin 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2015
Dernière vérification
1 mai 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIR 04-170
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