Activity and Life After Survival of a Cardiac Arrest
| ISRCTN | ISRCTN74835019 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74835019 |
| Secondary identifying numbers | date 08-02-2007/ version 2 |
- Submission date
- 04/04/2007
- Registration date
- 01/06/2007
- Last edited
- 26/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Véronique Moulaert
Scientific
Scientific
Research Department
Rehabilitation Foundation Limburg
P.O. Box 88
Hoensbroek
6430 AB
Netherlands
| v.moulaert@srl.nl |
Study information
| Study design | Prospective cohort study with a nested randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Activity and Life After Survival of a Cardiac Arrest |
| Study acronym | ALASCA |
| Study objectives | 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(s) | Medical Ethics Commitee of Maastricht University/Maastricht Academic Hospital, 14/03/2007 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2007 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 240 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rehabilitation Foundation Limburg
Hoensbroek
6430 AB
Netherlands
6430 AB
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
P.O. Box 93245
Den Haag
2509 AE
Netherlands
| Website | http://www.zonmw.nl |
|---|---|
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/08/2007 | Yes | No | |
| Results article | process evaluation results | 23/01/2014 | Yes | No | |
| Results article | results | 15/08/2015 | Yes | No |
