Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Véronique Moulaert

ORCID ID

Contact details

Research Department
Rehabilitation Foundation Limburg
P.O. Box 88
Hoensbroek
6430 AB
Netherlands
v.moulaert@srl.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

date 08-02-2007/ version 2

Study information

Scientific title

Acronym

ALASCA

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Survivors of a cardiac arrest, hypoxic brain injury

Intervention

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

01/04/2007

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

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

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

240

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

01/04/2007

Recruitment end date

01/04/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Research Department
Hoensbroek
6430 AB
Netherlands

Sponsor information

Organisation

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

Sponsor details

P.O. Box 93245
Den Haag
2509 AE
Netherlands

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17723148
2014 process evaluation results in: http://www.ncbi.nlm.nih.gov/pubmed/24456999

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.

Editorial Notes