Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Véronique Moulaert


Contact details

Research Department
Rehabilitation Foundation Limburg
P.O. Box 88
6430 AB

Additional identifiers

EudraCT number number

Protocol/serial number

date 08-02-2007/ version 2

Study information

Scientific title

Activity and Life After Survival of a Cardiac Arrest



Study hypothesis

1.1. The level of cognitive, emotional and cardiorespiratory impairment, daily functioning, participation in society and quality of life are expected to be lower than in the general population. Daily functioning and participation in society are lower than before the cardiac arrest. Caregiver strain is expected to be higher than in the general population
1.2. Cognitive functioning is significantly related to participation in society and quality of life. Participation is significantly related to quality of life. Caregiver strain is higher when the levels of functioning of the cardiac arrest survivor are lower
2. Expected prognostic factors for cognitive impairment, daily functioning, participation in society and quality of life one year after a cardiac arrest are: age, educational level, early Cardiopulmonary resuscitation (CPR), initial cardiac rhythm, duration of the hypoxic period (interval collapse-to-return of spontaneous circulation), Glasgow Coma Score at admission, application of mild therapeutic hypothermia, duration post-traumatic amnesia, Implantable Cardioverter Defibrillator (ICD) placement, cognitive functioning (measured with O-log) at two weeks, cardiorespiratory functioning, presence of a caregiver
3.1. The routine early intervention service after survival of a cardiac arrest is more effective than usual care with regard to the level of participation in society and quality of life
3.2. The routine early intervention service is cost-effective compared to usual care
3.3. The routine early intervention service has an acceptable cost-utility (cost per Quality Adjusted Life Year [QALY])

Ethics approval

Medical Ethics Commitee of Maastricht University/Maastricht Academic Hospital, 14/03/2007

Study design

Prospective cohort study with a nested randomised controlled clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Survivors of a cardiac arrest, hypoxic brain injury


The intervention group receives a routine early intervention service consisting of several contacts with a specialised nurse. The intervention is directed at early detection of (cognitive) problems, information supply and provision of support to the patient and their caregiver. If indicated, the patient can be referred to specialised care. The intervention will take place during the first three months after the cardiac arrest. Participants will have three to six consultations with the specialised nurse.

The control group receives care as usual.

Intervention type



Not Specified

Drug names

Primary outcome measure

1. Participation in society
2. Quality of life

All outcome measures will be admistered two weeks, three months and one year after the cardiac arrest.

Secondary outcome measures

1. Cognitive, emotional and cardiorespiratory impairment
2. Daily functioning
3. Caregiver strain

All outcome measures will be admistered two weeks, three months and one year after the cardiac arrest.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

All survivors of a cardiac arrest (survival greater than two weeks) admitted at or to one of the participating hospitals between April 2007 and April 2011

Participant type


Age group

Not Specified


Not Specified

Target number of participants


Participant exclusion criteria

1. Severe non-cardiac co-morbidity with a life expectancy lower than three months
2. Participant was living in an institutional care facility prior to the cardiac arrest

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Rehabilitation Foundation Limburg
6430 AB

Sponsor information


The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

P.O. Box 93245
Den Haag
2509 AE

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations



Funder name

The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2007 protocol in:
2014 process evaluation results in:
2015 results in:

Publication citations

  1. Protocol

    Moulaert VR, Verbunt JA, van Heugten CM, Bakx WG, Gorgels AP, Bekkers SC, de Krom MC, Wade DT, Activity and Life After Survival of a Cardiac Arrest (ALASCA) and the effectiveness of an early intervention service: design of a randomised controlled trial., BMC Cardiovasc Disord, 2007, 7, 26, doi: 10.1186/1471-2261-7-26.

  2. Process evaluation results

    Moulaert VR, van Haastregt JC, Wade DT, van Heugten CM, Verbunt JA, 'Stand still …, and move on' , an early neurologically-focused follow-up for cardiac arrest survivors and their caregivers: a process evaluation., BMC Health Serv Res, 2014, 14, 34, doi: 10.1186/1472-6963-14-34.

  3. Results

    Moulaert VR, van Heugten CM, Winkens B, Bakx WG, de Krom MC, Gorgels TP, Wade DT, Verbunt JA, Early neurologically-focused follow-up after cardiac arrest improves quality of life at one year: A randomised controlled trial., Int J Cardiol, 2015, 193, 8-16, doi: 10.1016/j.ijcard.2015.04.229.

Additional files

Editorial Notes