AnxietyNCT02888028
Quality of Life and Device Acceptance in Patients With ICD Undergoing Remote ICD FU
A study testing ICD remote monitoring in people with Anxiety and Depression, run by LMU Klinikum at 2 sites in Germany.
Trial summary
This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- ICD remote monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesGermany
- Study dates
- May 2011to Jun 2014
- 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
- Patients willing to participate
- Patients with new-implantation of an ICD or device replacement due to battery depletion between May 2011 and April 2013
- Sufficient knowledge of the German language
- Expectancy of life >1 years at good clinical status
- Written informed consent
Who cannot join
- Age <18 years
- Subjects not able to give written informed consent
- Subjects without sufficient German language skills
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Bielefeld University, School of public health
Bielefeld, 33615
Munich University Clinic, Campus Grosshadern
Munich, 81377
About this study
Official title: Quality of Life and Device Acceptance in Patients With Implantable Cardioverter-defibrillators Undergoing Remote ICD Follow-up
This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Patients are randomized to either conventional in-office FU only or additional remote surveillance, follow-up duration is 12 months. The influence of other variables (age, sex,..) is evaluated regarding their influence on study endpoints.
Read the detailed description
The rising number of implantable cardiac devices leads to an increasing amount of device-related workload, e.g. regular in-office follow-ups (FU). New means of ICD FU strategies are necessary to handle the increasing burden. ICD remote monitoring promises a time- and cost efficient alternative to conventional in-office FU strategies. Many studies have already shown benefits on FU burden reduction, on saving of costs and time, and recently on total mortality. The impact of remote ICD FU on Quality of life, anxiety and depression levels and device acceptance is still under discussion. The aim of this trial is to investigate the influence of additional remote ICD surveillance on the primary endpoint health related quality of life (HRQoL), further on levels of anxiety and depression and on device acceptance.
- Conditions
- Anxiety, Depression
- Being tested
- ICD remote monitoring, Control group
- Keywords
- Remote ICD follow-up, HRQoL, Health related Quality of Life, Depression, anxiety, device acceptance, telemedicine, telemonitoring
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD remote monitoringProcedure or surgery
ICD remote monitoring additionally to regular in-office visits
Control groupOther
Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU
| Study group | Role | What they receive |
|---|---|---|
| ICD remote monitoring | Active comparator | Active Comparator: ICD remote monitoring additionally to regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement Receives: Procedure: ICD remote monitoring |
| Control group | Other | Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire
Measured: 12 months
Secondary outcomes (2)
Influence of ICD remote monitoring on levels of anxiety and depression, measured by the HADS questionnaire (Hospital Anxiety and Depression scale)
Measured: 12 months
Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Bielefeld
- Responsible party
- Principal investigator, Johannes Siebermair, MD, LMU Klinikum
- Investigators
- Johannes Siebermair, MD, Principal investigator, Munich University Clinic, Campus Grosshadern, Munich, GermanyFlorian Leppert, MSc, Principal investigator, Bielefeld University, School of public health Bielefeld, GermanyStefan Kääb, MD, Principal investigator, Munich University Clinic, Campus Grosshadern, Munich, GermanyWolfgang Greiner, MD, Principal investigator, Bielefeld University, School of public health, Bielefeld, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888028
- Sponsor's protocol ID
- GE IDE MucM001-11
- Status last verified
- Jun 2018
- First submitted
- 3 Jul 2014
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Device Acceptance in Patients With Implantable Cardioverter-defibrillators Undergoing Remote ICD Follow-up
- ClinicalTrials.gov ID
- NCT02888028
- Acronym / sponsor ID
- GE IDE MucM001-11
- Conditions
- Anxiety, Depression
- Keywords
- Remote ICD follow-up, HRQoL, Health related Quality of Life, Depression, anxiety, device acceptance, telemedicine, telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Klinikum Bielefeld
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Sep 2016 (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.
This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Patients are randomized to either conventional in-office FU only or additional remote surveillance, follow-up duration is 12 months. The influence of other variables (age, sex,..) is evaluated regarding their influence on study endpoints.
Detailed description
The rising number of implantable cardiac devices leads to an increasing amount of device-related workload, e.g. regular in-office follow-ups (FU). New means of ICD FU strategies are necessary to handle the increasing burden. ICD remote monitoring promises a time- and cost efficient alternative to conventional in-office FU strategies. Many studies have already shown benefits on FU burden reduction, on saving of costs and time, and recently on total mortality. The impact of remote ICD FU on Quality of life, anxiety and depression levels and device acceptance is still under discussion. The aim of this trial is to investigate the influence of additional remote ICD surveillance on the primary endpoint health related quality of life (HRQoL), further on levels of anxiety and depression and on device acceptance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD remote monitoring | Active comparator | Procedure: ICD remote monitoringActive Comparator: ICD remote monitoring additionally to regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement |
| Control group | Other | Other: Control groupRegular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients willing to participate
- Patients with new-implantation of an ICD or device replacement due to battery depletion between May 2011 and April 2013
- Sufficient knowledge of the German language
- Expectancy of life >1 years at good clinical status
- Written informed consent
Key exclusion criteria (3 listed)
- Age <18 years
- Subjects not able to give written informed consent
- Subjects without sufficient German language skills
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 |
|---|---|---|
| ICD remote monitoringICD remote monitoring additionally to regular in-office visits | Procedure or surgery | ICD remote monitoring |
| Control groupRegular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU | Other | Control group |
Primary outcome
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire
Time frame: 12 months
2 secondary outcomes
Influence of ICD remote monitoring on levels of anxiety and depression, measured by the HADS questionnaire (Hospital Anxiety and Depression scale)
Time frame: 12 months
Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS)
Time frame: 12 months
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 21 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Johannes Siebermair, MD principal investigator
Munich University Clinic, Campus Grosshadern, Munich, Germany
Florian Leppert, MSc principal investigator
Bielefeld University, School of public health Bielefeld, Germany
Stefan Kääb, MD principal investigator
Munich University Clinic, Campus Grosshadern, Munich, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD remote monitoring in people with Anxiety and Depression, run by LMU Klinikum at 2 sites in Germany.
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 5 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire (time frame: 12 months). 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 21 Jun 2018.