ArrhythmiaNCT00845234
Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education
A study testing Intervention in people with Arrhythmia, run by East Carolina University at 3 sites in United States.
Trial summary
An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years old
- literate
- newly implanted with an implantable cardioverter defibrillator (ICD)
Who cannot join
- documented neurological sequelae associated with CVA or dementia
- documented cognitive impairment
- reported illiteracy
- previously implanted ICD
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
East Carolina Heart Institute
Greenville, North Carolina, 27834
Aurora Denver Cardiology Associates
Lone Tree, Colorado, 80124
About this study
Official title: Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. At present, there is a paucity of brief interventions for ICD patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. The present study examined the impact of a brief cognitive behavioral (CBT) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. It was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.
- Conditions
- Arrhythmia
- Being tested
- Intervention
- Keywords
- behavioral intervention, implantable cardioverter defibrillator, psychosocial education, anxiety, depression
- Medical subject headings
- Arrhythmias, Cardiac, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Intervention consisted of a brief, educational CBT intervention and included the following domain areas: ICD knowledge and post-discharge care, understanding shock, stress management, family and relationships, device recall, and survivorship. The intervention was provided at baseline (0 weeks). Intervention was led by investigator and lasted 15 minutes in duration.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | No intervention | Received the current standard of care as operationally defined by the investigators- Q\&A session + Video |
| Intervention Group | Experimental | Intervention group- Patients will receive the brief educational CBT intervention + video and Q\&A session Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on measure assessing construct of quality of life
Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.
Measured: Up to 8 months after enrollment
Secondary outcomes (3)
Score on measure assessing depression
Depression will be assessed via participant's self-reported scores on the depression subscale of the Hospital Anxiety and Depression Scale (HADS).
Measured: Up to 8 months after enrollment
score on measure assessing construct of patient acceptance of device
The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator.
Measured: up to 8 months after enrollment
score on measure assessing anxiety
The Hospital Anxiety and Depression Scale is comprised of two subscales- anxiety and depression. It is a self-report measure that generates a score on the patient's current level of anxiety.
Measured: Up to 8 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJul 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Aurora Denver Cardiology Associates, Medtronic
- Responsible party
- Principal investigator, Samuel F. Sears, East Carolina University
- Investigators
- Samuel F Sears, Ph.D., Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845234
- Sponsor's protocol ID
- 00293-2008-0356-1
- Status last verified
- Feb 2013
- First submitted
- 17 Feb 2009
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
- ClinicalTrials.gov ID
- NCT00845234
- Acronym / sponsor ID
- 00293-2008-0356-1
- Conditions
- Arrhythmia
- Keywords
- behavioral intervention, implantable cardioverter defibrillator, psychosocial education, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Aurora Denver Cardiology Associates, Medtronic
- Study start
- Jul 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. At present, there is a paucity of brief interventions for ICD patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. The present study examined the impact of a brief cognitive behavioral (CBT) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. It was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | No intervention | –Received the current standard of care as operationally defined by the investigators- Q\&A session + Video |
| Intervention Group | Experimental | Behavioral: InterventionIntervention group- Patients will receive the brief educational CBT intervention + video and Q\&A session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years old
- literate
- newly implanted with an implantable cardioverter defibrillator (ICD)
Key exclusion criteria (4 listed)
- documented neurological sequelae associated with CVA or dementia
- documented cognitive impairment
- reported illiteracy
- previously implanted ICD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionIntervention consisted of a brief, educational CBT intervention and included the following domain areas: ICD knowledge and post-discharge care, understanding shock, stress management, family and relationships, device recall, and survivorship. The intervention was provided at baseline (0 weeks). Intervention was led by investigator and lasted 15 minutes in duration. | Behavioural | Intervention Group |
Primary outcome
Score on measure assessing construct of quality of life
Time frame: Up to 8 months after enrollment
Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.
3 secondary outcomes
Score on measure assessing depression
Time frame: Up to 8 months after enrollment
score on measure assessing construct of patient acceptance of device
Time frame: up to 8 months after enrollment
score on measure assessing anxiety
Time frame: Up to 8 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel F Sears, Ph.D. principal investigator
East Carolina University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Arrhythmia, run by East Carolina University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on measure assessing construct of quality of life (time frame: Up to 8 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2013.