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1.  ‘Stand still …, and move on’ , an early neurologically-focused follow-up for cardiac arrest survivors and their caregivers: a process evaluation 
Background
A cardiac arrest can lead to hypoxic-ischaemic brain injury which can result in cognitive and emotional impairments and may negatively affect daily functioning, participation in society and quality of life. Furthermore, the impact on the family of the patient can be high. We designed an intervention called ‘Stand still …, and move on’, which is a concise, individualised, semi-structured intervention for survivors of cardiac arrest and their caregivers, consisting of between one and six face-to-face consultations provided by a trained nurse. The intervention is directed at early detection of cognitive and emotional problems, provision of information, promotion of self-management and referral to specialised care if necessary. The effectiveness of the intervention is being examined in a randomised controlled trial [ISRCTN74835019]. Alongside this trial we performed a process evaluation which aims to investigate the feasibility of the intervention by assessing: 1) the attendance and dose delivered; 2) performance according to protocol; and 3) the opinion of patients, caregivers and nurses on the intervention.
Methods
Participants of this process evaluation were 97 patients allocated to the intervention group of the RCT, their 91 caregivers, and six nurses who conducted the intervention. Measurement instruments used were evaluation forms for patients and caregivers, registration and evaluation forms for nurses, and semi-structured interviews with nurses.
Results
Seventy-nine of the patients (81%) allocated to the intervention group and 65 caregivers (71%) participated in the intervention. The mean (SD) number of consultations per patient was 1.8 (1.0), and most consultations were conducted at the patients’ home. The intervention was performed largely according to protocol, except that the intervention usually started later than intended, consultations were longer than expected, and the topic of self-management was not regularly addressed. Patients marked the quality of the intervention with a mean score of 7.5 and the performance of the nurse with an 8.0 out of ten. Overall, the intervention was positively evaluated by patients, caregivers and nurses.
Conclusions
The intervention ‘Stand still …, and move on’ is a promising intervention which was performed largely according to protocol and seems feasible for implementation after some adaptations, if it is found to be effective.
doi:10.1186/1472-6963-14-34
PMCID: PMC3904407  PMID: 24456999
Cardiac arrest; Hypoxic-ischaemic brain injury; Cognitive impairments; Emotional impairments; Caregiver; Nursing intervention; Feasibility; Process evaluation
2.  The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial 
BMC Neurology  2012;12:51.
Background
Post-Stroke Depression with or without Anxiety (PSDA) is a common disorder in the chronic phase of stroke. Neuropsychiatric problems, such as PSDA, have a negative impact on social reintegration and quality of life. Currently, there is no evidence-based treatment available for reducing PSDA symptoms. In the recent literature on depression in the general population it has been shown that depression complaints can diminish by cognitive behavioural therapy (CBT). In the current study, the effectiveness of augmented, activation-based and individually tailored CBT on the reduction of depression and anxiety will be investigated in patients with PSDA. Additionally, the effects on various secondary outcome measures, such as quality of life, goal attainment and societal participation will be evaluated. This study is embedded in a consortium of 4 interrelated studies on quality of life after stroke (Restore4Stroke).
Methods/design
A multi-centre, assessor-blind, randomized controlled trial is conducted. A sample of 106 PSDA patients, as assessed with the Hospital Anxiety and Depression Scale (HADS depression subscale >7), will be recruited and randomly allocated to either an experimental or a control group. The experimental intervention consists of an augmented CBT intervention. The intervention is based on CBT principles of recognizing, registering, and altering negative thoughts and cognitions so that mood, and emotional symptoms are improved. CBT is augmented with direct in-vivo activation offered by occupational or movement therapists. Patients in the control group will receive a computerized cognitive training intervention. Outcomes will be assessed at baseline, immediately post intervention, and at 6 and 12 months follow up.
Discussion
This study is the first randomized clinical trial that evaluates the (maintenance of) effects of augmented CBT on post-stroke depression with or without anxiety symptoms. Together with three other projects, the Restore4Stroke PSDA trial will provide novel information about the (treatment of) emotional problems and quality of life after stroke.
Trial registration
Trial registration number: Dutch Trial Register NTR2999
doi:10.1186/1471-2377-12-51
PMCID: PMC3433315  PMID: 22769041
Post-Stroke Depression; Cognitive Behavioural Therapy; Anxiety
3.  The economic impact of stroke in The Netherlands: the €-restore4stroke study 
BMC Public Health  2012;12:122.
Background
Stroke has a considerable socio-economic impact worldwide and is the leading cause of disabilities in the Western world. Economic studies of stroke focus merely on physical aspects and clinical interventions. To our current knowledge there is no comprehensive economic study investigating the economic impact of stroke including psychological and social aspects. The €-Restore4Stroke project, part of a large comprehensive research programme Restore4Stroke, aims to investigate the total economic impact of stroke in the Netherlands.
Methods
Two trial-based economic evaluation studies will be conducted within the €-Restore4Stroke project: one focussing on a self-management intervention and one on an augmented cognitive behavioural therapy intervention. Both include cost-effectiveness analyses and cost-utility analyses as primary research methods. Furthermore, a cost-of-illness study investigating costs after stroke attached to a cohort study and a record linkage study in which four databases are linked to investigate patterns of health care consumption before and after stroke, are embedded in €-Restore4Stroke. All studies will be performed from a societal perspective. The primary outcome measure for the cost-effectiveness analysis is the increase in health status on the primary outcome scales. Within the cost-utility analysis, the primary outcome measure is quality-adjusted life years (QALYs) for which an indirect preference-based technique will be used. In the self-management study we will also look at the estimation of health effects on informal caregivers. Cost outcomes in the cost-of-illness study will be computed with a cost questionnaire and linkage of several databases will be used to derive outcomes in the record linkage study,
Discussion
€-Restore4Stroke will provide new insights and evidence for the economic impact of psychosocial consequences after stroke. Besides being innovative in various ways (i.e. focussing on the chronic phase after stroke and including personal factors as possible determinants of long-term re-integration including quality of life in a prospective longitudinal design), a major strength of €-Restore4Stroke is that we include impact on informal caregivers. The outcomes of this study will provide health care decision makers with valuable and necessary information regarding stroke care related decisions.
Trial registration
NTR3051 (RCT Self-management), NTR2999 (RCT Augmented Cognitive Behavioural Therapy)
doi:10.1186/1471-2458-12-122
PMCID: PMC3305460  PMID: 22329910
4.  ‘Stand still … , and move on’, a new early intervention service for cardiac arrest survivors and their caregivers: rationale and description of the intervention 
Clinical Rehabilitation  2011;25(10):867-879.
This series of articles for rehabilitation in practice aims to cover a knowledge element of the rehabilitation medicine curriculum. Nevertheless they are intended to be of interest to a multidisciplinary audience. The competency addressed in this article is ‘The trainee demonstrates a knowledge of diagnostic approaches for specific impairments including cognitive dysfunction as a result of cardiac arrest.’
Abstract
Objective: To describe a new early intervention service for survivors of cardiac arrest and their caregivers, and to explain the evidence and rationale behind it.
Rationale: A cardiac arrest may cause hypoxic–ischaemic brain injury, which often results in cognitive impairments. Survivors of cardiac arrest can also encounter emotional problems, limitations in daily life, reduced participation in society and a decreased quality of life. A new early intervention service was designed based on literature study, expert opinion and patient experiences.
Description of the intervention: The early intervention service is an individualized programme, consisting of one to six consultations by a specialized nurse for the patient and their caregiver. The intervention starts soon after discharge from the hospital and can last up to three months. The intervention consists of screening for cognitive and emotional problems, provision of information and support, promotion of self-management strategies and can include referral to further specialized care if indicated.
Discussion: This intervention is assumed to reduce future problems related to hypoxic–ischaemic brain injury in the patient and caregiver, and its effectiveness is currently being investigated in a randomized controlled multicentre trial.
doi:10.1177/0269215511399937
PMCID: PMC3255518  PMID: 21565869
Heart arrest; hypoxic brain injury; cognitive impairment; rehabilitation interventions; nursing care
5.  Activity and Life After Survival of a Cardiac Arrest (ALASCA) and the effectiveness of an early intervention service: design of a randomised controlled trial 
Background
Cardiac arrest survivors may experience hypoxic brain injury that results in cognitive impairments which frequently remain unrecognised. This may lead to limitations in daily activities and participation in society, a decreased quality of life for the patient, and a high strain for the caregiver. Publications about interventions directed at improving quality of life after survival of a cardiac arrest are scarce. Therefore, evidence about effective rehabilitation programmes for cardiac arrest survivors is urgently needed. This paper presents the design of the ALASCA (Activity and Life After Survival of a Cardiac Arrest) trial, a randomised, controlled clinical trial to evaluate the effects of a new early intervention service for survivors of a cardiac arrest and their caregivers.
Methods/design
The study population comprises all people who survive two weeks after a cardiac arrest and are admitted to one of the participating hospitals in the Southern part of the Netherlands. In a two-group randomised, controlled clinical trial, half of the participants will receive an early intervention service.
The early intervention service consists of several consultations with a specialised nurse for the patient and their caregiver during the first three months after the cardiac arrest. The intervention is directed at screening for cognitive problems, provision of informational, emotional and practical support, and stimulating self-management. If necessary, referral to specialised care can take place. Persons in the control group will receive the care as usual.
The primary outcome measures are the extent of participation in society and quality of life of the patient one year after a cardiac arrest. Secondary outcome measures are the level of cognitive, emotional and cardiovascular impairment and daily functioning of the patient, as well as the strain for and quality of life of the caregiver. Participants and their caregivers will be followed for twelve months after the cardiac arrest.
A process evaluation will be performed to gain insight into factors that might have contributed to the effectiveness of the intervention and to gather information about the feasibility of the programme. Furthermore, an economic evaluation will be carried out to determine the cost-effectiveness and cost-utility of the intervention.
Discussion
The results of this study will provide evidence on the effectiveness of this early intervention service, as well as the cost-effectiveness and its feasibility.
Trial registration
Current Controlled Trials [ISRCTN74835019]
doi:10.1186/1471-2261-7-26
PMCID: PMC2077869  PMID: 17723148

Results 1-5 (5)