LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD) (AICD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01686490|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : September 18, 2012
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
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.
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686490
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Joseph Gordon Rogers, MD||Duke University, Eed Director, Cardiac Transplant and Mechanical Circulatory Support Program|