NCT00245817

Brief Summary

HINCAB-study is a single senter, prospective, randomised controlled trial. The aim of the study is to test the effect of a home based intervention program. The hypothesis of the study is that a home based intervention will influencing coping strategies in the CABG-patients rehabilitation phase, reduce symptoms and improve health related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

March 11, 2011

Status Verified

December 1, 2010

Enrollment Period

1.4 years

First QC Date

October 27, 2005

Last Update Submit

March 10, 2011

Conditions

Keywords

Anxiety. Depression. HRQOL. Psycho-educative intervention

Outcome Measures

Primary Outcomes (1)

  • Anxiety and depression symptoms

    6 months

Secondary Outcomes (1)

  • Health related quality of life

    6 months

Interventions

HINCABBEHAVIORAL

Psycho-educative intervention performed 2 and 4 weeks after surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevål University Hospital

Oslo, Norway

Location

Related Publications (4)

  • Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Health-related quality of life after coronary artery bypass grafting. The impact of a randomised controlled home-based intervention program. Qual Life Res. 2009 Mar;18(2):201-7. doi: 10.1007/s11136-008-9438-y. Epub 2009 Jan 25.

  • Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Effects of a home-based intervention program on anxiety and depression 6 months after coronary artery bypass grafting: a randomized controlled trial. J Psychosom Res. 2007 Apr;62(4):411-8. doi: 10.1016/j.jpsychores.2006.11.010.

  • Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Predictors for physical and mental health 6 months after coronary artery bypass grafting: a cohort study. Eur J Cardiovasc Nurs. 2010 Dec;9(4):238-43. doi: 10.1016/j.ejcnurse.2010.02.001. Epub 2010 Mar 9.

  • Lie I, Bunch EH, Smeby NA, Arnesen H, Hamilton G. Patients' experiences with symptoms and needs in the early rehabilitation phase after coronary artery bypass grafting. Eur J Cardiovasc Nurs. 2012 Mar;11(1):14-24. doi: 10.1016/j.ejcnurse.2010.09.004.

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Irene Lie, PhD student

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR
  • Eli H Bunch, Professor

    Institute of Nursing and Health Science

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

August 1, 2003

Primary Completion

January 1, 2005

Study Completion

July 1, 2005

Last Updated

March 11, 2011

Record last verified: 2010-12

Locations