NCT02976961

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

5.9 years

First QC Date

November 22, 2016

Last Update Submit

December 3, 2024

Conditions

Implantable Defibrillator UserDistress

Keywords

InformationEmpowerment

Outcome Measures

Primary Outcomes (1)

  • Device acceptance

    Measured with the Florida Patient Acceptance Survey (FPAS)

    12 months

Secondary Outcomes (11)

  • Health status (generic)

    12 and 24 months

  • Patient empowerment (ICD-EMPOWER)

    12 and 24 months

  • ICD patient concerns (ICDC)

    12 and 24 months

  • Symptoms of anxiety

    12 and 24 months

  • Symptoms of depression

    12 and 24 months

  • +6 more secondary outcomes

Study Arms (2)

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

Other: Supportive care

Usual care

NO INTERVENTION

Implantable cardioverter defibrillator implant + usual care

Interventions

Supportive careOTHER

Information, guidance, supportive care, and psychological intervention

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a first-time ICD or CRT-D
  • ≥18 years of age

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Zealand University Hospital - Roskilde

Roskilde, 4000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29969990DERIVED

MeSH Terms

Conditions

Empowerment

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Susanne S Pedersen, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 30, 2016

Study Start

February 6, 2017

Primary Completion

December 31, 2022

Study Completion

May 8, 2023

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)