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
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
-
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.
-
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.