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CompletedNCT02522663AVRreUpdated Mar 9, 2018

The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial

An interventional study of 24/7-telephone support in Aortic Valve Disease, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Aortic Valve Replacement (AVR) surgery for aortic valve disease continues to increase in numbers. With better surgical techniques and equipment, also older patients can be operated on, resulting in an growth of the older population. AVR is characterized by high rates of hospital readmissions, resulting in suboptimal care planning and higher health care costs. Hence, it is important to develop strategies to reduce hospital readmissions following AVR. The purpose if this study is to develop and test the efficacy of a 24/7-phone support in the reduction of readmissions after AVR treatment. Secondary outcomes are a reduced level of anxiety, less depressive symptoms and a better health related quality of life.

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Conditions studied

  • Aortic Valve Disease

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Keywords

  • telephone support
  • discharge management
  • readmission
  • aortic valve replacement
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In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's enrollment of 288 is above the median of 108 across 116 interventional studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft
  • Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires
  • Can be contacted by phone after discharge from hospital

Exclusion criteria

Exclusion criteria:

  • Patients who have been admitted to intensive care for more than 24 hours
  • Patients who have complications related to surgery e.g. cerebral insult with significant impact on cognitive functions after surgery
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
288 participants (actual)

Study arms

  • No intervention
    Usual Care

    Today, no post-discharge telephone support is offered as standard care from the hospital.

  • Experimental
    Intervention group

    Experimental group is offered 24/7-telephone support during the first 1 month post-discharge, and patients are actively called at day 2 and day 9 day after discharge.

    Other: 24/7-telephone support

Interventions

  • Other24/7-telephone support

    ICU nurses answer the calls from treated AVR patients during the first month after discharge, and use an evidence-based information manual to answer questions from the patients.

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What researchers measure

Primary outcomes

  1. Reduced readmissions

    Will use data from the national patient registry: Norway Patient Registry (NPR) and data from patient journals to measure the readmission rates. Main measure will be readmission rate 30 days after discharge for Aortic Valve Replacement (AVR).

    Time frame: 1 year follow-up

Secondary outcomes

  1. Reduced anxiety

    Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on anxiety. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR

    Time frame: 1 year follow-up

  2. Reduced depression

    Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on depression. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR.

    Time frame: 1 year follow-up

  3. Increased health related quality of life

    Will use EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR

    Time frame: 1 year follow-up

  4. Reduced costs

    Will use data from the national patient registry: Norway Patient Registry, data from the patients journals and data from The Norwegian Health Economics Administration (HELFO). Cost-utility analysis to compare intervention group with the control group.

    Time frame: 1 year follow-up

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Study locations

1 site
  • Oslo University Hospital
    Oslo, Norway
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References and documents

Publications

  • Danielsen SO, Moons P, Leegaard M, Solheim S, Tonnessen T, Lie I. Facilitators of and barriers to reducing thirty-day readmissions and improving patient-reported outcomes after surgical aortic valve replacement: a process evaluation of the AVRre trial. BMC Health Serv Res. 2020 Mar 27;20(1):256. doi: 10.1186/s12913-020-05125-5. PubMed 32220252 ↗
  • Danielsen SO, Moons P, Sandvik L, Leegaard M, Solheim S, Tonnessen T, Lie I. Impact of telephone follow-up and 24/7 hotline on 30-day readmission rates following aortic valve replacement -A randomized controlled trial. Int J Cardiol. 2020 Feb 1;300:66-72. doi: 10.1016/j.ijcard.2019.07.087. Epub 2019 Jul 30. PubMed 31387822 ↗
  • Lie I, Danielsen SO, Tonnessen T, Solheim S, Leegaard M, Sandvik L, Wisloff T, Vangen J, Rosstad TH, Moons P. Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trial. Trials. 2017 May 30;18(1):246. doi: 10.1186/s13063-017-1971-y. PubMed 28693599 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02522663
Lead sponsor
Oslo University Hospital
Collaborators
The Bergesen Foundation, Raagholt Foundation, Norwegian Extra Foundation for Health and Rehabilitation
Responsible party
Stein Ove Danielsen (Research Fellow, Oslo University Hospital) — Principal investigator
First posted
Aug 13, 2015
Start date
Aug 20, 2015
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Last update
Mar 9, 2018

Study contacts

Stein O Danielsen
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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