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A Randomized Trial: Changing Behavior in Post-Angioplasty Patients

17. februar 2017 opdateret af: Mary E. Charlson, MD, Weill Medical College of Cornell University
The long-term objective of this study is to determine whether a positive affect and self-affirmation condition added to an empirically demonstrated approach for motivating behavior change is more effective than a standard approach in reducing risk factor behavior among a high-risk group of patients with coronary artery disease. Thus, the goal of the project is to refine and improve strategies for long-term maintenance of physical activity among patients post-angioplasty or stent.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Among coronary artery disease patients who have just had either angioplasty or stents, the objective of this randomized trial is to evaluate whether a novel behavioral intervention that employs induced positive affect and self-affirmation is more effective than an intervention without positive affect in increasing the maintenance of newly initiated physical activity post-procedure.

Secondary objectives:

  • To determine whether more patients who receive the positive affect and self-affirmation intervention initiate more multiple behavior changes (e.g., changes in more health behaviors directed to their risk-factor profile) than those in the control group at one year.
  • To determine whether the positive affect and self-affirmation intervention increases physical activity among patients who have depressive symptoms.
  • To determine whether patients who are successful in increasing physical activity are more successful at changing other health behaviors.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

242

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10021
        • The New York Presbyterian Hospital-Weill Medical Center

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 110 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment.
  • Patients must be able to provide informed consent within the one week after the procedure.

Exclusion Criteria:

  • Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
  • Enrollment in other trials designed to modify post-procedure behaviors.
  • Patients who refuse to participate will be excluded.
  • If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.

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
Ingen indgriben: Control Group
This group received follow-up every 2-months for one year. Follow-up included questions about their heart disease progression and how well they had been able to engage in their doctor approved physical activity goal.
Eksperimentel: Intervention Group
This group received follow-up every 2-months for one year. Follow-up included questions about their heart disease progression and how well they had been able to engage in their doctor approved physical activity goal, which was the same as the control arm. Additionally, subjects in this arm were encouraged to use positive affect and self-affirmation techniques to motivate an increased level of participation in their physical activity goal. These subjects also received small token gifts to remind them of their study participation.
Adfærdsmæssigt: Intervention Group
During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
Andre navne:
  • Postivie affect and self-affirmation induction vs. control

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Within patient change in the Paffenbarger Exercise and Physical Activity Index
Tidsramme: basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout
basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout

Samarbejdspartnere og efterforskere

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

Sponsor

Weill Medical College of Cornell University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. oktober 2004

Primær færdiggørelse (Faktiske)

1. januar 2008

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

3. november 2005

Først indsendt, der opfyldte QC-kriterier

3. november 2005

Først opslået (Skøn)

4. november 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • N01-HC-25196 (0203-694)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No Plan to Share IPD

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 .

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