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A Behavioral Intervention To Improve Hypertension Control In Veterans

8 maj 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

533

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New York
      • New York, New York, Förenta staterna, 10010
        • VA New York Harbor Health Care System

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Stage-matched intervention (SMI)
Stage-matched intervention
Health Education Intervention
Usual Care
Aktiv komparator: Health Education Intervention (HEI)
Stage-matched intervention
Health Education Intervention
Usual Care
Inget ingripande: Usual Care (UC)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood Pressure Control
Tidsram: 6 months
Blood pressure Control at 6 months
6 months
Systolic Blood Pressure
Tidsram: 6 months
Mean systolic Blood Pressure
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Proportion With BP Under Control From Baseline to 6 Months
Tidsram: 6 months
6 months
Change in Systolic Blood Pressure From Baseline to 6 Months
Tidsram: Baseline and 6 months
Baseline and 6 months
Change in Number of Cardio Exercise Hours From Baseline to 6 Months
Tidsram: baseline and 6 months
baseline and 6 months
Change in Morisky Score From Baseline to 6 Months
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Sundar Natarajan, MD MSc, VA New York Harbor Health Care System

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2006

Primärt slutförande (Faktisk)

1 januari 2010

Avslutad studie (Faktisk)

1 september 2011

Studieregistreringsdatum

Först inskickad

1 februari 2006

Först inskickad som uppfyllde QC-kriterierna

1 februari 2006

Första postat (Uppskatta)

3 februari 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

1 juni 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 maj 2015

Senast verifierad

1 maj 2015

Mer information

Termer relaterade till denna studie

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