Implantable Defibrillator UserACQUIRE-ICDNCT02976961
A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care
A study testing Supportive care in people with Implantable Defibrillator User and Distress, run by Susanne Schmidt Pedersen at 5 sites in Denmark.
Trial summary
This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Defibrillator User, Distress
- What is being tested?
- Supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 5 sitesDenmark
- Study dates
- 6 Feb 2017to 8 May 2023
- 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 with a first-time ICD or CRT-D
- ≥18 years of age
Who cannot join
- Subcutaneous ICD
- Upgrade from a pacemaker to ICD or CRT
- History of psychiatric illness other than affective/anxiety disorders
- Cognitive impairments (e.g. dementia)
- Left ventricular assist device (LVAD) or upcoming LVAD implant
- Under evaluation or on the waiting list for heart transplantation
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- No e-mail address
- Inability to manage or cope with computer technology
- Insufficient knowledge of the Danish language
- Participation in other randomized controlled trials unless of a technical nature
- Irresponsible to ask patient to participate according to GCP
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Aalborg University Hospital
Aalborg, 9100
Aarhus University Hospital
Aarhus, 8000
Gentofte Hospital
Gentofte Municipality, Hellerup, 2900
Odense University Hospital
Odense, 5000
Zealand University Hospital - Roskilde
Roskilde, 4000
About this study
Official title: A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and CaRE of Patients with an Implantable Cardioverter Defibrillator
This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.
- Conditions
- Implantable Defibrillator User, Distress
- Being tested
- Supportive care
- Keywords
- Information, Empowerment
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive careOther
Information, guidance, supportive care, and psychological intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge Receives: Other: Supportive care |
| Usual care | No intervention | Implantable cardioverter defibrillator implant + usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device acceptance
Measured with the Florida Patient Acceptance Survey (FPAS)
Measured: 12 months
Secondary outcomes (11)
Health status (generic)
Measured with the Short Form Health Survey 12 items (SF-12)
Measured: 12 and 24 months
Patient empowerment (ICD-EMPOWER)
Purpose-designed and disease-specific 14-item measure that measures patient empowerment
Measured: 12 and 24 months
ICD patient concerns (ICDC)
8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient
Measured: 12 and 24 months
Symptoms of anxiety
Generalized Anxiety Disorder scale (GAD-7)
Measured: 12 and 24 months
Symptoms of depression
Patient Health Questionnaire (PHQ-9)
Measured: 12 and 24 months
Health status (heart failure specific)
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measured: 12 and 24 months
Return to work
Purpose-designed questions
Measured: 12 and 24 months
Time to first ICD therapy
Defined as ATP, cardioversion or shock
Measured: 12 and 24 months
Time to first hospitalization due to a cardiac cause
Hospitalization due to a cardiac cause
Measured: 12 and 24 months
Time to mortality
Mortality
Measured: 12 and 24 months
Cost-effectiveness
Incremental cost gained per quality adjusted life year (QALY) and burden on health care professionals (physicians and nurses)). This will be measured with the EQ-5D-5L or captured from the patient's electronic health record (EHR; e.g. number of phone calls, emails, and consultations with patients), and purpose-designed questions.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start6 Feb 2017
- Primary completion31 Dec 2022
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implantable Defibrillator UserStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Schmidt Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital
- Responsible party
- Sponsor-investigator, Susanne Schmidt Pedersen, University of Southern Denmark
- Investigators
- Susanne S Pedersen, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976961
- Sponsor's protocol ID
- 31779
- Acronym
- ACQUIRE-ICD
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2016
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen SS, Skovbakke SJ, Wiil UK, Schmidt T, dePont Christensen R, Brandt CJ, Sorensen J, Vinther M, Larroude CE, Melchior TM, Riahi S, Smolderen KGE, Spertus JA, Johansen JB, Nielsen JC. Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial. BMC Cardiovasc Disord. 2018 Jul 3;18(1):136. doi: 10.1186/s12872-018-0872-7.
PubMed 29969990
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and CaRE of Patients with an Implantable Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT02976961
- Acronym / sponsor ID
- ACQUIRE-ICD / 31779
- Conditions
- Implantable Defibrillator User, Distress
- Keywords
- Information, Empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Susanne Schmidt PedersenUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 30 Nov 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 evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Supportive careImplantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge |
| Usual care | No intervention | –Implantable cardioverter defibrillator implant + usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a first-time ICD or CRT-D
- ≥18 years of age
Key exclusion criteria (11 listed)
- Subcutaneous ICD
- Upgrade from a pacemaker to ICD or CRT
- History of psychiatric illness other than affective/anxiety disorders
- Cognitive impairments (e.g. dementia)
- Left ventricular assist device (LVAD) or upcoming LVAD 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 |
|---|---|---|
| Supportive careInformation, guidance, supportive care, and psychological intervention | Other | Intervention |
Primary outcome
Device acceptance
Time frame: 12 months
Measured with the Florida Patient Acceptance Survey (FPAS)
11 secondary outcomes
Health status (generic)
Time frame: 12 and 24 months
Patient empowerment (ICD-EMPOWER)
Time frame: 12 and 24 months
ICD patient concerns (ICDC)
Time frame: 12 and 24 months
Symptoms of anxiety
Time frame: 12 and 24 months
Symptoms of depression
Time frame: 12 and 24 months
Health status (heart failure specific)
Time frame: 12 and 24 months
Return to work
Time frame: 12 and 24 months
Time to first ICD therapy
Time frame: 12 and 24 months
Time to first hospitalization due to a cardiac cause
Time frame: 12 and 24 months
Time to mortality
Time frame: 12 and 24 months
Cost-effectiveness
Time frame: 12 and 24 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 6 Dec 2024.
- Derived from this study: PubMed 29969990Pedersen SS, Skovbakke SJ, Wiil UK, Schmidt T, dePont Christensen R, Brandt CJ, Sorensen J, Vinther M, Larroude CE, Melchior TM, Riahi S, Smolderen KGE, Spertus JA, Johansen JB, Nielsen JC. Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial. BMC Cardiovasc Disord. 2018 Jul 3;18(1):136. doi: 10.1186/s12872-018-0872-7.
- 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.
Susanne S Pedersen, PhD principal investigator
University of Southern Denmark
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care in people with Implantable Defibrillator User and Distress, run by Susanne Schmidt Pedersen at 5 sites in Denmark.
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 2 inclusion and 11 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
Device acceptance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976961, which also lists 1 linked publication.
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 6 Dec 2024.