The overall aim of the present study is to develop and test a cognitive rehabilitation intervention for OHCA patients with cognitive deficits. The intervention will be designed to improve cognitive functioning in the domains of attention, memory,…
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
hersenschade
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the score on a Visual Analogue Scale (VAS) of
the severity of the main, predefined daily life problem caused by an objective
cognitive deficit that the participant is dealing with. This problem is
personalized for each participant, but is always related to an objective
disturbance of attention, memory, and/or executive functioning. The VAS score
varies between 0 and 10, 0 indicating no problem and 10 indicating the most
severe problem imaginable. This VAS score is obtained daily via an app, before
and during the intervention (phase A and B), and weekly to biweekly during the
follow-up (phase C).
Secondary outcome
Secundary parameters:
• Generalization measure: This variable is collected to test whether improved
functioning on the primary outcome generalizes towards other aspects of daily
functioning. This measure consists of other personal daily life problems caused
by the objective cognitive impairment next to the primary outcome measure, and
some general, non-personalized questions. The general questions are about the
impaired cognitive domains (*To what extent did you experience problems with
your memory / attention and concentration / planning and problem-solving since
the last app notification?*). The generalization measure will be expressed as
the score between 0 to 10 on three VAS, and also collected on a daily basis via
an app before and during the intervention (phase A and B), and weekly to
biweekly during the follow-up (phase C).
Other study parameters
• On the level of cognitive functioning: Before the intervention phase
starts, the participant will complete a neuropsychological assessment
consisting of the Auditory Verbal Learning Test (memory), Rivermead Stories
(memory), Digit Span (attention and working memory), Coding task (attention),
and Letter Fluency task (executive functioning) in order to provide modules
that suit the patients impairment(s) and complaint(s).
Before the intervention (start phase B), after the intervention (end phase B),
and at 3 month follow up (end phase C), a small neuropsychological assessment
will be done in order to establish changes within three cognitive domains:
Letter Fluency task (executive functioning), Auditory Verbal Learning Test
(memory), and Digit Span (attention and working memory).
• The CLC-IC questionnaire will be administered at baseline (start phase A),
before the intervention (start phase B), after the intervention (end phase B),
and at 3 month follow up (end phase C), to assess the cognitive complaints of
the patient. It consists of 10 multiple choice (*yes* or *no*) questions, and 2
open questions. If possible, this questionnaire is also filled out by the
partner.
• To assess subjective memory complaints, the most frequent impaired cognitive
domain after OHCA, the Everyday Memory Questionnaire-revised will be
administered at baseline (start phase A), before the intervention (start phase
B), after the intervention (end phase B), and at 3 month follow up (end phase
C). It covers five categories of memory failure: Five categories of failure:
speech, reading and writing, faces and places, actions, and learning new
things.
• On the level of quality of life and participation: The LiSat-9 and USER-P
restriction questionnaires will be administered at baseline (start phase A),
before the intervention (start phase B), after the intervention (end phase B),
and at 3 month follow up (end phase C). If possible, the USER-P restriction
questionnaire is also filled out by the partner.
• Structural and functional MRI data will be collected at baseline (start phase
A), and 3 months after the end of the intervention (end phase C). These data
will be used to assess brain structural and functional connectivity, including
spatiotemporal characteristics of cerebral rearrangements that associate with
cognitive recovery. We will collect measures of resting state functional
connectivity and structural integrity of white matter tracts with blood
oxygenation level-dependent (BOLD) MRI and diffusion tensor imaging (DTI) on a
clinical 3T scanner. Functional connectivity will be expressed in a
region-based way and at a whole network level. The architecture of neuronal
fibers will be based on DTI-derived diffusion anisotropy, principle diffusion
direction in white matter, and tractography algorithms.
• Demographics and medical history. Most demographic information will be
obtained in the context of current care and collected from patient files. If
necessary, missing data will be collected by asking the participant. The
demographic information will consist of age, level of education, handedness,
and living situation. Medical history will be obtained from the medical patient
file. This entails information about the time since the OHCA, duration till
resuscitation, time to return of spontaneous circulation, cause of cardiac
arrest, duration of hospitalization, risk factors for a cardiac arrest, any
comorbid disorders.
Background summary
Increasing number of cardiac arrest survivors with cognitive impairments
Global incidence of out-of-hospital cardiac arrest (OHCA) with cardiac
aetiology is estimated at approximately .50 to .55 events per 1000 citizens a
year, with large variations across regions (Berdowski, Berg, Tijssen, & Koster,
2010). The yearly incidence of OHCA in the Netherlands lies around 0.6 to 0.9
per 1000 inhabitants, resulting in approximately 16.000 cases each year
(Waalewijn, De Vos, & Koster, 1998). The survival rate after attempted
resuscitation of OHCA patients lies between 9 and 37% (Dyson et al., 2016;
Herlitz et al., 2003; Kuisma & Määttä, 1996). Due to education of basic life
support to a wide range of civilians, dense networks of automated external
defibrillators throughout the country, and improvements in the healthcare
system, the survival rate has increased in the Netherlands from 16% in 2006 to
41% in 2016 in patients with a shockable rhythm (Berdowski, Waalewijn, &
Koster, 2006).
Although the rising percentage of survivors of OHCA is a positive development,
it does have a flipside. A common consequence of cardiac arrest is
ischemic-hypoxic brain damage leading to cognitive impairment. According to a
large systematic review, approximately 50% of the cardiac arrest survivors have
cognitive deficits (V. Moulaert, Verbunt, van Heugten, & Wade, 2009). This
means that because more people survive OHCA, a growing number of people are
suffering from its long term cognitive consequences. The cognitive domains most
often affected are memory, attention, and executive functioning (V. Moulaert et
al., 2009). Cognitive impairments of OHCA patients are significantly associated
with lower participation in society and quality of life (Lilja et al., 2018;
Wachelder et al., 2009). Early recognition of and attention for cognitive
disturbances do have a positive effect. This is supported by the study of V. R.
Moulaert et al. (2015), showing that an early intervention focussed on
detection of cognitive consequences and subsequent tailored education to
improve long term quality of life and well-being after cardiac arrest.
Cognitive rehabilitation therapy could potentially enhance these positive
effects. However, effect sizes of targeted cognitive rehabilitation treatments
on cognitive functioning and daily life of cardiac arrest survivors are unknown
(Boyce, Goossens, Moulaert, Pound, & van Heugten, 2019).
Direct cognitive training combined with metacognitive strategies are effective
in acquired brain injury
Currently, there is a lack of knowledge regarding efficacy of treatments to
improve outcomes of patients with cognitive impairment after a cardiac arrest.
However, there is a large body of evidence to support the efficacy of cognitive
rehabilitation in closely related neurological disorders such as stroke and
traumatic brain injury (Cicerone et al., 2011; C. van Heugten, Wolters
Gregório, & Wade, 2012). One method for cognitive rehabilitation is direct
cognitive training. Direct cognitive training targets a specific cognitive
domain. The proposed underlying mechanism is that repetitive training will
induce changes in the brain though neuroplasticity, leading to improvement in
the trained cognitive domain. Several promising cognitive intervention methods
have been developed that enable direct training, such as computer-based
cognitive rehabilitation (Fetta, Starkweather, & Gill, 2017). With
computer-based direct training patients can train their cognition by repeatedly
playing games that each challenge a specific cognitive domain. One program that
offers direct cognitive training is Rehacom (Fernández et al., 2012; Naeeni
Davarani et al., 2020). Rehacom consists of 29 therapy modules to improve a
specific cognitive function. The difficulty level of these modules can be
adjusted to the level of the patient, if the patient improves the difficulty
level also rises. Direct training with Rehacom has shown to improve cognitive
functioning in patients with acquired brain injury (Pantzartzidou et al., 2017;
Yoo, Yong, Chung, & Yang, 2015). Unfortunately, direct cognitive training often
suffers from a lack of transferability (Lintern & Boot, 2019; Melby-Lervåg &
Hulme, 2013; C. M. van Heugten, Ponds, & Kessels, 2016; Yoo et al., 2015). This
means that although the patients improve on the trained task itself, these
improvements do not generalize toward improved functioning in other tasks nor
in in daily life.
A method that is used in cognitive rehabilitation that does show
generalization of treatment results is training of metacognitive strategies.
Such strategies promote self-monitoring and self-regulation by asking
self-reflective questions that help to be a self-aware problem solver.
Metacognitive strategies are shown to have lasting effects on performance of
everyday tasks in several cognitive domains (Ownsworth, Quinn, Fleming,
Kendall, & Shum, 2010; Schmidt, Fleming, Ownsworth, & Lannin, 2013; Winkens,
Van Heugten, Wade, Habets, & Fasotti, 2009).
The Cognitive Rehabilitation Task Force of the American Congress of
Rehabilitation Medicine Brain Injury Interdisciplinary Special Interest Group
recommends to combine direct training with metacognitive strategies to improve
cognitive performance and promote generalization to daily functioning (Cicerone
et al., 2019). This has already been successfully applied to children and
adolescents with traumatic brain injury (Galbiati et al., 2009). In these
patients, combined metacognitive training and direct training of attention
skills resulted in improved social and adaptive skills in real-life contexts
(Galbiati et al., 2009). Based on these results, we expect that the combination
of direct cognitive training with meta-cognitive strategy training holds
potential to improve cognitive functioning and functional recovery of OHCA
patients with cognitive deficits.
Single Case Experimental Design is probably optimal to estimate effect sizes of
cognitive rehabilitation after OHCA
In heterogeneous patient groups such as OHCA, a classical clinical trial
comparing groups of patients has important disadvantages. First, large numbers
of patients are needed for sufficient statistical power, limiting feasibility.
Second, even despite large patient numbers, there is a considerable risk of
type II error, hampering identification and implementation of truly effective
treatments. This applies to cardiac arrest survivors in general and to
cognitive consequences in these patients in particular
A very promising research design that is increasingly used in the field of
rehabilitation is the single case experimental design (SCED). The main
characteristic of this design is that the unit of intervention and data
analysis is a single case that provides its own intervention and control data.
The outcome variable is repeatedly measured both in the absence and in presence
of a specific intervention. The power of a SCED comes from the number of
repeated measures and not from the number of patients. The SCED is well suited
to study a causal relationship between the manipulated independent variable and
the dependent outcome variable. An additional advantage of the SCED, that is
useful in intervention studies, is the adaptive nature of the design, meaning
that interventions and outcome measures can be tailored to the unique needs of
the patient (Kratochwill et al., 2010). Because of the advantages of a SCED,
there is an increasing amount of publications in the field of cognitive
rehabilitation that use this research design (Jamieson, Cullen, McGee-Lennon,
Brewster, & Evans, 2014). Because of the established guidelines, the quality of
a SCED can be ensured (Evans, Gast, Perdices, & Manolov, 2014; Krasny-Pacini &
Evans, 2018; Kratochwill et al., 2010; Perdices & Tate, 2009).
Study objective
The overall aim of the present study is to develop and test a cognitive
rehabilitation intervention for OHCA patients with cognitive deficits. The
intervention will be designed to improve cognitive functioning in the domains
of attention, memory, and/or executive functioning. For each included patient,
the intervention will be tailored to improve functioning on one predefined
problem in daily living that is related to objective disturbances in the
cognitive domains of memory, attention and/or executive functioning.
Study design
This will be a randomized multiple baseline SCED intervention study, in four
patients with cognitive disturbances after a cardiac arrest. The study will
consist of three phases for each participant: a baseline phase of 14-34 days
without intervention (A), a treatment phase of 42 days with direct training
combined with metacognitive training (B), and a follow-up phase without
intervention (C). The primary outcome measure will be collected daily during
phases A and B, and weekly to biweekly during phase C. In addition to the
repeated collection of the primary outcome measure, there will be a collection
of data from neuropsychological tests and questionnaires at the start of phase
A (day 1), the start of phase B (day 15-35), the end of phase B (day 57-77),
and the end of phase C (day 150).
Intervention
The intervention will consist of a combination of direct training of the
impaired cognitive function(s) and metacognitive strategy training for 42 days
(6 weeks). Direct training will be done with the computer program Rehacom for
20 minutes, 5 times a week. Metacognitive strategy training will be given every
week (6-10 sessions) by a trained therapist.
Rehacom is a brain training program developed to improve a variety of cognitive
functions with the use of game-like cognitive training modules. These modules
automatically adjust the level of difficulty to the performance of the
participant. A screening will be done to identify the most important cognitive
problems. Based on this, modules will be selected per participant to target the
cognitive domain(s) that are impaired. During the intervention, the participant
should train with Rehacom for approximately 600 minutes in total. If a
participant has not reached a minimum of 540 minutes of direct training at the
end of the intervention, the training period will be extended by a maximum of
one extra week.
In addition to the direct training, the participant receives six to ten
sessions of metacognitive strategy training. During this training, they are
taught strategies by a therapist to improve their performance on the Rehacom
modules and daily life functioning. Each metacognitive strategy is linked to
one of the Rehacom modules. For example, a participant will be taught a
metacognitive strategy, such as visualization, to improve on a memory module in
Rehacom. The participants are motivated to think of ways to apply the learned
strategy to challenges they face in their daily lives, especially the
predefined daily life problem caused by an objective cognitive deficit that the
participant is dealing with. In each session with the therapist, the
application of the strategy in their daily lives will be evaluated.
Study burden and risks
We foresee no relevant additional risk of cognitive rehabilitation therapy and
follow up in this study.
Dr Tanslaan 12
Maastricht 6229 ET
NL
Dr Tanslaan 12
Maastricht 6229 ET
NL
Listed location countries
Age
Inclusion criteria
a subject must be mentally competent and meet all of the following criteria:
• Objectified cardiac arrest between 3 months and 2 years before inclusion.
• Age 18 - 75
• Cognitive impairments objectified by a score on the Montreal Cognitive
Assessment (MoCA) <= 26 or abnormal scores on a neuropsychological assessment
caused by low scores (more than 1,5 standard deviation below the mean of the
norm group) on memory, attention, and/or executive functioning tasks
• Living independently (with minor help)
• Experiencing difficulties with more complex daily tasks (e.g. doing
groceries, following conversations, etc.)
• Motivated to improve cognitive functioning and to participate in the study
• Proficient in Dutch to understand instructions, follow the training program
and fill in the questionnaires
• Patients with a treatment indication for cognitive rehabilitation (as decided
by a psychiatrist)
• Written informed consent
Exclusion criteria
• Neurodegenerative disorder, or another brain disease known to impact
cognition, such as stroke
• Substance abuse impacting cognition
• Psychiatric disorder in need of treatment
• Uncorrected visual or auditory deficiencies
• Not in possession of a computer or lack of computer skills
• Severe amnesia or aphasia
• Illiteracy
• • MRI contra-indications:
o metal, magnetic, electric, or mechanic implants/objects in the body.
o claustrophobia
o pregnancy or breastfeeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL77453.068.21 |
Other | waiting for approval |