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

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Virginia P. Williams, Ph.D., Williams LifeSkills
ClinicalTrials.gov Identifier:
NCT01686490
First received: June 27, 2012
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Focus Whether After Implant Pre-AICD Video Was Helpful
Behavioral: Video/workbook for patients about to receive an AICD
Behavioral: LiveSkills Video/Workbook for patients about to receive an AICD
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator

Resource links provided by NLM:


Further study details as provided by Williams LifeSkills:

Primary Outcome Measures:
  • 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. [ Time Frame: After AICD patients who watched the video/workbook before implantation have been implanted. ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Video/workbook for patients about to receive an AICD
will view the 3 completed sections of the video/workbook
Behavioral: LiveSkills Video/Workbook for patients about to receive an AICD
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01686490

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Williams LifeSkills
Duke University
Investigators
Principal Investigator: Joseph Gordon Rogers, MD Duke University, Eed Director, Cardiac Transplant and Mechanical Circulatory Support Program
  More Information

No publications provided

Responsible Party: Virginia P. Williams, Ph.D., President,, Williams LifeSkills
ClinicalTrials.gov Identifier: NCT01686490     History of Changes
Other Study ID Numbers: 2924526, 1R41HL083635-01A2
Study First Received: June 27, 2012
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Williams LifeSkills:
AICD
focus groups
cognitive-behavioral video/workbook training
pre-implant concern/distress about upcoming AICD

ClinicalTrials.gov processed this record on July 28, 2014