Early neurologically-focused follow-up after cardiac arrest improves quality of life at one year: A randomised controlled trial.

BACKGROUND: Survivors of a cardiac arrest frequently have cognitive and emotional problems and their quality of life is at risk. We developed a brief nursing intervention to detect cognitive and emotional problems, provide information and support, promote self-management, and refer them to specialised care if necessary. This study examined its effectiveness. METHODS: Multicentre randomised controlled trial with measurements at two weeks, three months and twelve months after cardiac arrest. 185 adult cardiac arrest survivors and 155 caregivers participated. Primary outcome measures were societal participation and quality of life of the survivors at one year. Secondary outcomes were the patient's cognitive functioning, emotional state, extended daily activities and return to work, and the caregiver's well-being. Data were analysed using 'intention to treat' linear mixed model analyses. RESULTS: After one year, patients in the intervention group had a significantly better quality of life on SF-36 domains Role Emotional (estimated mean differences (EMD)=16.38, p=0.006), Mental Health (EMD=6.87, p=0.003) and General Health (EMD=8.07, p=0.010), but there was no significant difference with regard to societal participation. On the secondary outcome measures, survivors scored significantly better on overall emotional state (HADS total, EMD=-3.25, p=0.002) and anxiety (HADS anxiety, EMD=-1.79, p=0.001) at one year. Furthermore, at three months more people were back at work (50% versus 21%, p=0.006). No significant differences were found for caregiver outcomes. CONCLUSION: The outcomes of cardiac arrest survivors can be improved by an intervention focused on detecting and managing the cognitive and emotional consequences of a cardiac arrest. TRIAL REGISTRATION: Current controlled trials, ISRCTN74835019.

Accelerometry measuring the outcome of robot-supported upper limb training in chronic stroke: a randomized controlled trial.

PURPOSE: This study aims to assess the extent to which accelerometers can be used to determine the effect of robot-supported task-oriented arm-hand training, relative to task-oriented arm-hand training alone, on the actual amount of arm-hand use of chronic stroke patients in their home situation. METHODS: This single-blind randomized controlled trial included 16 chronic stroke patients, randomly allocated using blocked randomization (n = 2) to receive task-oriented robot-supported arm-hand training or task-oriented (unsupported) arm-hand training. Training lasted 8 weeks, 4 times/week, 2 × 30 min/day using the (T-)TOAT ((Technology-supported)-Task-Oriented-Arm-Training) method. The actual amount of arm-hand use, was assessed at baseline, after 8 weeks training and 6 months after training cessation. Duration of use and intensity of use of the affected arm-hand during unimanual and bimanual activities were calculated. RESULTS: Duration and intensity of use of the affected arm-hand did not change significantly during and after training, with or without robot-support (i.e. duration of use of unimanual use of the affected arm-hand: median difference of -0.17% in the robot-group and -0.08% in the control group between baseline and after training cessation; intensity of the affected arm-hand: median difference of 3.95% in the robot-group and 3.32% in the control group between baseline and after training cessation). No significant between-group differences were found. CONCLUSIONS: Accelerometer data did not show significant changes in actual amount of arm-hand use after task-oriented training, with or without robot-support. Next to the amount of use, discrimination between activities performed and information about quality of use of the affected arm-hand are essential to determine actual arm-hand performance. TRIAL REGISTRATION: Controlled-trials.com ISRCTN82787126.

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].