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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

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Pedersen, Susanne S ; Skovbakke, Søren J ; Wiil, Uffe K ; Schmidt, Thomas ; dePont Christensen, Rene ; Brandt, Carl J ; Sørensen, Jan ; Vinther, Michael ; Larroudé, Charlotte E ; Melchior, Thomas M ; Riahi, Sam ; Smolderen, Kim G E ; Spertus, John A ; Johansen, Jens B ; Nielsen, Jens C. / 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. I: BMC Cardiovascular Disorders. 2018 ; Bind 18, Nr. 1. s. 136.

Bibtex

@article{b2e181f8daf64a799918c4b8df0f9094,
title = "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",
abstract = "BACKGROUND: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes.METHODS: The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness.DISCUSSION: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients.TRIAL REGISTRATION: The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].",
keywords = "Defibrillators, Implantable, Denmark, Electric Countershock/adverse effects, Health Status, Heart Failure/diagnosis, Humans, Mental Health, Multicenter Studies as Topic, Patient Reported Outcome Measures, Predictive Value of Tests, Prospective Studies, Quality of Life, Randomized Controlled Trials as Topic, Remote Sensing Technology/instrumentation, Risk Factors, Telemedicine/instrumentation, Telemetry/instrumentation, Time Factors, Treatment Outcome",
author = "Pedersen, {Susanne S} and Skovbakke, {S{\o}ren J} and Wiil, {Uffe K} and Thomas Schmidt and {dePont Christensen}, Rene and Brandt, {Carl J} and Jan S{\o}rensen and Michael Vinther and Larroud{\'e}, {Charlotte E} and Melchior, {Thomas M} and Sam Riahi and Smolderen, {Kim G E} and Spertus, {John A} and Johansen, {Jens B} and Nielsen, {Jens C}",
year = "2018",
month = jul,
day = "3",
doi = "10.1186/s12872-018-0872-7",
language = "English",
volume = "18",
pages = "136",
journal = "BMC Cardiovascular Disorders",
issn = "1471-2261",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]

T2 - study protocol of a national Danish randomised controlled trial

AU - Pedersen, Susanne S

AU - Skovbakke, Søren J

AU - Wiil, Uffe K

AU - Schmidt, Thomas

AU - dePont Christensen, Rene

AU - Brandt, Carl J

AU - Sørensen, Jan

AU - Vinther, Michael

AU - Larroudé, Charlotte E

AU - Melchior, Thomas M

AU - Riahi, Sam

AU - Smolderen, Kim G E

AU - Spertus, John A

AU - Johansen, Jens B

AU - Nielsen, Jens C

PY - 2018/7/3

Y1 - 2018/7/3

N2 - BACKGROUND: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes.METHODS: The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness.DISCUSSION: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients.TRIAL REGISTRATION: The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

AB - BACKGROUND: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes.METHODS: The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness.DISCUSSION: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients.TRIAL REGISTRATION: The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

KW - Defibrillators, Implantable

KW - Denmark

KW - Electric Countershock/adverse effects

KW - Health Status

KW - Heart Failure/diagnosis

KW - Humans

KW - Mental Health

KW - Multicenter Studies as Topic

KW - Patient Reported Outcome Measures

KW - Predictive Value of Tests

KW - Prospective Studies

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Remote Sensing Technology/instrumentation

KW - Risk Factors

KW - Telemedicine/instrumentation

KW - Telemetry/instrumentation

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/s12872-018-0872-7

DO - 10.1186/s12872-018-0872-7

M3 - Journal article

C2 - 29969990

VL - 18

SP - 136

JO - BMC Cardiovascular Disorders

JF - BMC Cardiovascular Disorders

SN - 1471-2261

IS - 1

ER -

ID: 56982606