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

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.

Study Overview

• Status: Completed
• Conditions: Focus Whether After Implant Pre-AICD Video Was Helpful
• Intervention / Treatment: Behavioral: Video/workbook for patients about to receive an AICD; Behavioral: LiveSkills Video/Workbook for patients about to receive an AICD

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Williams LifeSkills
• Collaborators: Duke University
• Investigators: Principal Investigator: Joseph Gordon Rogers, MD, Duke University, Eed Director, Cardiac Transplant and Mechanical Circulatory Support Program

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Estimate): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 17, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: focus groups; AICD; cognitive-behavioral video/workbook training; pre-implant concern/distress about upcoming AICD
• Other Study ID Numbers: 2924526; 1R41HL083635-01A2 (U.S. NIH Grant/Contract)