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

NCT ID: NCT01686490

Last Updated: 2012-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

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.

Conditions

Focus Whether After Implant Pre-AICD Video Was Helpful

Keywords

AICD; focus groups; cognitive-behavioral video/workbook training; pre-implant concern/distress about upcoming AICD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Video/workbook for patients about to receive an AICD

Intervention Type: BEHAVIORAL

will view the 3 completed sections of the video/workbook

LiveSkills Video/Workbook for patients about to receive an AICD

Intervention Type: BEHAVIORAL

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.

Interventions

Video/workbook for patients about to receive an AICD

will view the 3 completed sections of the video/workbook

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Williams LifeSkills

INDUSTRY

Sponsor Role: lead

Responsible Party

Virginia P. Williams, Ph.D.

President,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Gordon Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University, Eed Director, Cardiac Transplant and Mechanical Circulatory Support Program

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1R41HL083635-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2924526

Identifier Type: -

Identifier Source: org_study_id