NCT00346112

Brief Summary

RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-KARE-01: A 3-month outpatient rehabilitation therapy and psychological counselling including informative talks with conventional therapy, by a cardiologist or general practitioner after implantation of an internal cardioverter defibrillator (ICD) in adult patients, whereby the effects of three different strategies are compared. Study hypothesis: the rehabilitation programme will be beneficial in the management of any psychological problems possibly as a result from the intervention, and will help to overcome anxiety, and contribute to improved quality of life.

Trial Health

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Trial Health Score

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

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

First QC Date

June 28, 2006

Last Update Submit

November 5, 2010

Conditions

Heart Patients After ICD Implantation

Keywords

ICDdistressanxietyquality-of-life

Outcome Measures

Primary Outcomes (1)

  • Anxiety and Depression

Interventions

psycho-educationalPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • First ICD implant within past 12 weeks
  • Agrees to sign patient/partner informed consent

You may not qualify if:

  • Angina pectoris CCS III \& IV
  • NYHA functional class IV
  • Inability to follow rehabilitation programme
  • Exercise limitations due to clinical condition
  • Symptomatic exercise-induced tachyarrhythmias
  • Any major non-cardiac condition that would adversely affect survival during study duration
  • Unable to comply to study procedures
  • Participates in a concurrent study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital (Inselspital) Berne

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jean-Paul Schmid

    Switzerland - University Hospital (Inselspital) Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2009

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations

CH(1)