PacemakerNCT00822965
Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs)
An observational study of Pacemaker and Implantable Cardioverter-Defibrillators, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The specific aims of the patient intervention are to: 1. increase patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) 2. help patients to identify if their PM or ICD has been interrogated 3. improve patient's physician-patient communication skills 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Implantable Cardioverter-Defibrillators
- What is being tested?
- Questionnaires, Phone Interviews and Educational Packet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2015
- Phase
- Observational
- 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
Study population: Consecutive patients presented to UTMDACC Preoperative Consultation Clinic from January 1, 2000 to November 15, 2008 with an implanted pulse generator.
Who may be able to join
- Consecutive patients (beginning with most recent date) who presented to UTMDACC Preoperative Consultation Clinic from January 1, 2000 to November 15, 2008 with an implanted pulse generator.
- English-speaking (Resources to translate materials and provide interviews in Spanish language or languages other than English are not available for this study).
- Adult patients 18 years of age or older.
Who cannot join
- Patients who fail to consent to participate.
- Patients with self-report of hearing impairment, sight, or reading impairment that would hinder ability to complete written surveys
- Patients who have a second implant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II
The specific aims of the patient intervention are to:
- increase patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs)
- help patients to identify if their PM or ICD has been interrogated
- improve patient's physician-patient communication skills
- teach patients how to identify if their device has been recalled
- train patients what to do in case of a device recall
The educational interventions proposed, if proven to be effective by this pilot, will provide a low-cost, reproducible intervention to improve the clinical care and safe management of pacemakers (PM) and implantable cardioverter-defibrillators (ICD) in patients. The goal of the intervention will be to promote the safe use of implantable pulse generators.
Read the detailed description
If you agree to take part in this study, you will complete 3 sets of questionnaires (at the beginning of the study, at 2-months and at 4-months) which will be sent to you and returned by you through the mail. This will not require you to travel to M.D. Anderson. In addition to the questionnaires, you will also complete 2 follow-up phone interviews.
Questionnaires:
The first set of questionnaires will be mailed to your home. The questionnaires will ask questions about your anxiety level and how much you know about pacemakers or implantable cardioverter-defibrillators. There will also be questions about your gender, age, ethnicity, and race. The questionnaires will take about 25 minutes to complete. When you are finished, you will mail the questionnaires to the study staff. An envelope with pre-paid postage will be provided.
Educational Packet:
After you have completed the questionnaires, you will receive an educational packet in the mail. The packet will have a DVD or a video (depending on whether you tell us you have a DVD player or a VHS player) with information on medical devices, device recall information (when and why certain devices have been recalled in the past), a list of on-line resources and benefits of routine follow-up.
Phone Interview:
The study staff will call your home 1 week after you receive the educational packet for a follow-up interview. A member of the study staff will review the packet with you. The phone call will last about 20 minutes.
Additional Questionnaires:
Approximately 2 months and at 4 months after you complete the first set of questionnaires, an additional set of questionnaires will be mailed to you. You will be asked to complete the same questionnaires as you did in the first set. At 4 months an additional questionnaire about the information in the educational packet and how useful it was to you will be included. The questionnaires will take about 25 minutes to complete. When you are finished, you will mail the questionnaires to the study staff. An envelope with pre-paid postage will be provided.
Length of Study:
You participation on this study is complete once you have completed the additional questionnaires.
This is an investigational study. Up to 104 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Pacemaker, Implantable Cardioverter-Defibrillators
- Being tested
- Questionnaires, Phone Interviews, Educational Packet
- Keywords
- Pacemakers, PM, Implantable cardioverter-defibrillators, ICD, Implantable pulse generators, Educational Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called Survey
3 sets of questionnaires at the beginning of the study, at 2-months and at 4-months.
Phone InterviewsOther
2 follow-up phone interviews.
Educational PacketBehavioural
Video or DVD of device information, updates, recalls, on-line resources and benefits of routine follow-up for device(s).
| Study group | Role | What they receive |
|---|---|---|
| Patient Knowledge Assessments | Questionnaires + Phone Interview Receives: Other: Questionnaires; Other: Phone Interviews; Behavioral: Educational Packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs)
Measured: Total knowledge score evaluated at baseline and at 2-month and 4-month post educational intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mike Hogg Foundation
- Responsible party
- Sponsor
- Investigators
- Maria Suarez-Almazor, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822965
- Sponsor's protocol ID
- 2008-0163
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2009
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II
- ClinicalTrials.gov ID
- NCT00822965
- Acronym / sponsor ID
- 2008-0163
- Conditions
- Pacemaker, Implantable Cardioverter-Defibrillators
- Keywords
- Pacemakers, PM, Implantable cardioverter-defibrillators, ICD, Implantable pulse generators, Educational Interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Mike Hogg Foundation
- Study start
- Jan 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jan 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.
The specific aims of the patient intervention are to:
- increase patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs)
- help patients to identify if their PM or ICD has been interrogated
- improve patient's physician-patient communication skills
- teach patients how to identify if their device has been recalled
- train patients what to do in case of a device recall
The educational interventions proposed, if proven to be effective by this pilot, will provide a low-cost, reproducible intervention to improve the clinical care and safe management of pacemakers (PM) and implantable cardioverter-defibrillators (ICD) in patients. The goal of the intervention will be to promote the safe use of implantable pulse generators.
Detailed description
If you agree to take part in this study, you will complete 3 sets of questionnaires (at the beginning of the study, at 2-months and at 4-months) which will be sent to you and returned by you through the mail. This will not require you to travel to M.D. Anderson. In addition to the questionnaires, you will also complete 2 follow-up phone interviews.
Questionnaires:
The first set of questionnaires will be mailed to your home. The questionnaires will ask questions about your anxiety level and how much you know about pacemakers or implantable cardioverter-defibrillators. There will also be questions about your gender, age, ethnicity, and race. The questionnaires will take about 25 minutes to complete. When you are finished, you will mail the questionnaires to the study staff. An envelope with pre-paid postage will be provided.
Educational Packet:
After you have completed the questionnaires, you will receive an educational packet in the mail. The packet will have a DVD or a video (depending on whether you tell us you have a DVD player or a VHS player) with information on medical devices, device recall information (when and why certain devices have been recalled in the past), a list of on-line resources and benefits of routine follow-up.
Phone Interview:
The study staff will call your home 1 week after you receive the educational packet for a follow-up interview. A member of the study staff will review the packet with you. The phone call will last about 20 minutes.
Additional Questionnaires:
Approximately 2 months and at 4 months after you complete the first set of questionnaires, an additional set of questionnaires will be mailed to you. You will be asked to complete the same questionnaires as you did in the first set. At 4 months an additional questionnaire about the information in the educational packet and how useful it was to you will be included. The questionnaires will take about 25 minutes to complete. When you are finished, you will mail the questionnaires to the study staff. An envelope with pre-paid postage will be provided.
Length of Study:
You participation on this study is complete once you have completed the additional questionnaires.
This is an investigational study. Up to 104 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Knowledge Assessments | – | Other: Questionnaires, Other: Phone Interviews, Behavioral: Educational PacketQuestionnaires + Phone Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presented to UTMDACC Preoperative Consultation Clinic from January 1, 2000 to November 15, 2008 with an implanted pulse generator.
Key inclusion criteria (3 listed)
- Consecutive patients (beginning with most recent date) who presented to UTMDACC Preoperative Consultation Clinic from January 1, 2000 to November 15, 2008 with an implanted pulse generator.
- English-speaking (Resources to translate materials and provide interviews in Spanish language or languages other than English are not available for this study).
- Adult patients 18 years of age or older.
Key exclusion criteria (3 listed)
- Patients who fail to consent to participate.
- Patients with self-report of hearing impairment, sight, or reading impairment that would hinder ability to complete written surveys
- Patients who have a second implant
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 |
|---|---|---|
| QuestionnairesAlso: Survey3 sets of questionnaires at the beginning of the study, at 2-months and at 4-months. | Other | Patient Knowledge Assessments |
| Phone Interviews2 follow-up phone interviews. | Other | Patient Knowledge Assessments |
| Educational PacketVideo or DVD of device information, updates, recalls, on-line resources and benefits of routine follow-up for device(s). | Behavioural | Patient Knowledge Assessments |
Primary outcome
Patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs)
Time frame: Total knowledge score evaluated at baseline and at 2-month and 4-month post educational intervention.
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 7 Jan 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Maria Suarez-Almazor, MD, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker and Implantable Cardioverter-Defibrillators, run by M.D. Anderson Cancer Center at 1 site 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 3 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) (time frame: Total knowledge score evaluated at baseline and at 2-month and 4-month post educational intervention.). 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 7 Jan 2016.