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Effects of Lifeskills Workshop on BP in Hypertensive Employees (Lifeskills BP)

RCT of LifeSkills Workshop on BP in Hypertensive Employees

A number of psychosocial risk factors have been strongly related to a range of health problems (chief among them CVD). Clinical research has shown that behavioral interventions have enormous promise to ameliorate the psychosocial distress, the health-damaging effects and the costs associated with these risk factors. However, few such programs have been implemented in a large-scale way. Corporations are increasingly interested in providing such services for their employees, but they have encountered difficulties in knowing which programs are most effective. Until these programs are developed as products that can be tested and shown to produce consistent benefits, dissemination of these beneficial programs will be hindered. Taken together, these findings make a strong case that the development of a standardized, protocol-driven behavioral intervention package that can be delivered in a wide range of corporate settings presents a remarkable commercial opportunity. The overall goal of this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that documents the effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session workshop) in reducing BP, psychosocial risk factors, and promoting positive health outcomes in a cost effective manner in a corporate setting. This empirical support, tested in a setting independent of the program developers and by an experienced research team, will then be used to help market the product in the corporate wellness marketplace. It is hypothesized that participants (employees in an urban medical center) in the LifeSkills intervention will experience greater reductions in blood pressure and improvements in measures of psychosocial well-being than those receiving usual medical care and given educational materials on reducing BP.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

181

Fase

  • Fase 2

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults age 18-75
  • Employees of Columbia University Medical Center
  • BP >= 140/90 on 2 occasions (average of 3 readings each time)

Exclusion Criteria:

  • Pregnancy
  • End-stage Renal disease
  • BP > 165/110 (average over 3 readings)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LifeSkills workshop intervention
Participants attended 10 1-hr weekly sessions. The content of the groups followed the LifeSkills Workshop manual and Video(Williams LifeSkills, Inc, Durham NC). The LifeSkills Workshop is a structured psycho-educational group intervention using workbooks and videotapes that draw on cognitive-behavioral techniques and stress reduction approaches.
Intervention participants attended 10 one-hour weekly group sessions. The content of the groups followed the LifeSkills Workshop manual and Video ( (Williams LifeSkills, Inc, Durham NC). The LifeSkills Workshop is a structured psycho-educational group intervention using workbooks and videotapes that draw on cognitive-behavioral techniques and stress reduction approaches.
Ingen indgriben: Enhanced usual care
The Usual Care group received a self-help brochure on BP control developed by the National Heart, Lung, and Blood Institute (NHLBI). In addition, with the participants' permission, their BP readings were sent to their listed physicians, along with the 1-page JNC-7 express summary for the management of high BP.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in mean office BP, covarying hostility and hostility x time (stratification variable)
Tidsramme: 2 months after end of treatment
The change in the mean office BP (evaluated automatically by BP-Tru device) from baseline to follow-up. Hostility, evaluated by Cook-Medley questionnaire (Barefoot scoring) was a stratification variable and thus was used as a covariate in the analysis
2 months after end of treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Changes in mean office BP, controlling for baseline medications and medication changes during trial
Tidsramme: baseline to follow-up 2 months after end of intervention
baseline to follow-up 2 months after end of intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Lynn P Clemow, PhD, Columbia University

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. september 2002

Primær færdiggørelse (Faktiske)

1. august 2006

Studieafslutning (Faktiske)

1. august 2006

Datoer for studieregistrering

Først indsendt

15. december 2010

Først indsendt, der opfyldte QC-kriterier

15. december 2010

Først opslået (Skøn)

17. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2016

Sidst verificeret

1. november 2010

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Lifeskills BP study
  • R44HL067584 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med Lifeskills Workshop Intervention

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