ACQUIRE-ICD: A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care

• Sponsor: Susanne Schmidt Pedersen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02976961
• Collaborator: Odense University Hospital (Other), Aarhus University Hospital (Other), Aalborg University Hospital (Other), University Hospital, Gentofte, Copenhagen (Other), Zealand University Hospital (Other)
• Enrollment: 478
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 82.8
• Patients Per Site: 95.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Implantable Defibrillator User; Distress	Other: Supportive care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 478 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Feb 6, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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; Information, guidance, supportive care, and psychological intervention
No Intervention: Usual care Implantable cardioverter defibrillator implant + usual care

Outcome Measures

Primary Outcome Measures

1. Device acceptance [12 months]

   Measured with the Florida Patient Acceptance Survey (FPAS)

Secondary Outcome Measures

1. Health status (generic) [12 and 24 months]

   Measured with the Short Form Health Survey 12 items (SF-12)

2. Patient empowerment (ICD-EMPOWER) [12 and 24 months]

   Purpose-designed and disease-specific 14-item measure that measures patient empowerment

3. ICD patient concerns (ICDC) [12 and 24 months]

   8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient

4. Symptoms of anxiety [12 and 24 months]

   Generalized Anxiety Disorder scale (GAD-7)

5. Symptoms of depression [12 and 24 months]

   Patient Health Questionnaire (PHQ-9)

6. Health status (heart failure specific) [12 and 24 months]

   Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

7. Return to work [12 and 24 months]

   Purpose-designed questions

8. Time to first ICD therapy [12 and 24 months]

   Defined as ATP, cardioversion or shock

9. Time to first hospitalization due to a cardiac cause [12 and 24 months]

   Hospitalization due to a cardiac cause

10. Time to mortality [12 and 24 months]

    Mortality

11. Cost-effectiveness [12 and 24 months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with a first-time ICD or CRT-D

• ≥18 years of age

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gentofte Hospital	Gentofte	Hellerup	Denmark	2900
2	Aalborg University Hospital	Aalborg		Denmark	9100
3	Aarhus University Hospital	Aarhus		Denmark	8000
4	Odense University Hospital	Odense		Denmark	5000
5	Zealand University Hospital - Roskilde	Roskilde		Denmark	4000

Sponsors and Collaborators

• Susanne Schmidt Pedersen
• Odense University Hospital
• Aarhus University Hospital
• Aalborg University Hospital
• University Hospital, Gentofte, Copenhagen
• Zealand University Hospital

Investigators

• Principal Investigator: Susanne S Pedersen, PhD, University of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susanne Schmidt Pedersen, Professor, University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT02976961
• Other Study ID Numbers: 31779
• First Posted: Nov 30, 2016
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Susanne Schmidt Pedersen, Professor, University of Southern Denmark: Information; Empowerment

Study Results

No Results Posted as of Jul 15, 2022