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LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD) (AICD)

17. september 2012 opdateret af: Virginia P. Williams, Ph.D., Williams LifeSkills

LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator

The purpose of this trial was to develop the initial sections of a video/DVD cassette that provided guidance about mastering stressful situations for patients who had been informed that they need an implantable cardioverter-defibrillator (AICD). We adapted the existing LifeSkills video (which was already been shown effective in patients with heart diseases) to the specific needs of patients with AICD's. Before its development, we held separate focus groups with healthcare providers of AICD patients, pre-implantation patients, and post-implantation patients. After the video/accompanying workbook was produced, we held an additional focus group with patients who had received the video/workbook before receiving their AICD.

Studieoversigt

Detaljeret beskrivelse

Patients who had received the video/workbook told the focus group leader that they wanted more information about their AICD and a clearer presentation about how stress management was related to living with their AICD.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

37

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University 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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult patients (age> 21 years old)
  • For one of the initial focus groups and for the focus group of patients who had watched the produced modules: Patients who have received a recommendation for an AICD and have agreed to have it in the pre-implantation stage (do not already have the implant)
  • For the other initial focus group: patients who already have an AICD.

Exclusion Criteria:

  • Patients who are medically unstable [New York Heart Association class IV heart failure, recent (within 30 days) myocardial infarction or admission for unstable angina or worsening heart failure, in-patients, or patients who were admitted less than 1 month before potential enrollment will be excluded].
  • Patients who are suffering from other medical illnesses: only the following categories will be exclusionary: Diseases that cause severe cognitive impairment that may lead to inability to understand or follow study procedures (i.e., severe dementia, identified by the patients' inability to repeat the study procedures and by a mini-mental status exam that will be done if dementia is suspected); Diseases that cause severe psychotic symptoms leading to disorientation (i.e., hepatic encephalopathy).
  • Patients who are actively suicidal (suspected from the suicide question on the depression questionnaire
  • Patients who cannot understand the study procedures due to cognitive or language barriers (provided an effort was made to offer translation).
  • The process for dealing with individuals who indicate that they may be suicidal, depressed or anxious will be as follows: Immediately upon receipt of the completed questionnaires at the coordinating office, the Beck Depression Inventory and the Impact of Event Scale will be evaluated. If the responses indicate suicidal ideation the subject will be called and asked to contact his/her primary care provider for an immediate appointment. The primary care provider will be contacted that day to inform him/her of the finding. If the responses to the Impact of Event Scale or the BDI indicate stress or depression, a letter will be sent to the subject recommending that he/she contact the primary care provider. A copy of the letter will be forwarded to the PCP.

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: D.
The focus is evaluation of LifeSkills Video/Workbook for patients about to receive an AICD. Patients who now have received their AICD were given a video/workbook pre-implantation as an intervention to reduce their concerns/distress. After implantation, they will be asked what was and was not helpful about the materials they received.
will view the 3 completed sections of the video/workbook
This exploratory intervention first met in a focus group with healthcare professionals and another focus group with patients who already had received an automatic implantable cardiac defibrillator to learn more about what video and accompanying workbook material it would be helpful for patients to receive pre-inplantation. Another focus group was held with post-implantation patients asking them what additional knowledge would have been helpful. Three sections of the video with accompanying workbook were then produced and given to pre-inplantation patients. A focus group was then held with these patients after their procedure to ask them what had and had not proved helpful.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Whether patients understood the contents of the produced sections of the video/workbook and whether these contents were helpful. This will be determined by their comments during a focus group which will be held after they have watched the video.
Tidsramme: After AICD patients who watched the video/workbook before implantation have been implanted.
AICD patients who watched the first three sections of the proposed video with accompanying workbook will be asked in a focus group if they found the information comprehensible and if the information was helpful.
After AICD patients who watched the video/workbook before implantation have been implanted.

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Joseph Gordon Rogers, MD, Duke University, Eed Director, Cardiac Transplant and Mechanical Circulatory Support Program

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. december 2007

Primær færdiggørelse (Faktiske)

1. august 2009

Studieafslutning (Faktiske)

1. august 2009

Datoer for studieregistrering

Først indsendt

27. juni 2012

Først indsendt, der opfyldte QC-kriterier

17. september 2012

Først opslået (Skøn)

18. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. september 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2924526
  • 1R41HL083635-01A2 (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 .

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