The objective of this study therefore is to investigate the clinical effects and the usability of a new and unique intervention 'nonconfrontational feedback' for improving awareness of deficits. The intervention given at the start of (…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet-aangeboren hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of the intervention is to improve self-awareness of deficits.
The main study parameter is change between T0 (baseline) and T6 (12 months
after T0) in terms of self-awareness of deficits (SRSI).
The reason for adding additional post-measurements (T1, T2, T3, T4, T5) is
twofold. First, adding additional post-measurements increases statistical power
(see for example Vickers,2003). Second, adding additional post-measurements
makes it possible to look at differences between the control group and
experimental group in the course of recovery/response to treatment (e.g. does
the experimental group reach a certain level of self-awareness of deficits more
quickly than the control group).
Secondary outcome
Secundairy goals are:
- on the short term improve self-awareness of deficits, motivation for
rehabiliation treatment and participation in rehabilitation treatment.
Study parameters are changes between T0 (baseline) and T2 (6 weeks after the
start of cognitive rehabilitation) in terms of self-awareness of deficits
(PCRS, SRSI), motivation for treatment (from the perspective of the patient
(MOT-Q) and from the perspective of the therapist (VAS-scale)), and
participation in rehabilitation treatment from the perspective of the therapist
(PRPS).
- on the long term improve quality of life, social participation and mood.
Study parameters are changes between T3 (3 months after T0) and T6 (12 months
after T0) in terms self-awareness of deficits (PCRS), quality of life
(SS-QOL-12), social participation (USER-P), mood (HADS-D).
- finally it will be evaluated whether the new intervention is usable from the
perspective of rehabiliation professionals als well as patients (in terms of
among other things patient satisfaction, burden/worklaod for the patient,
length and content of sessions, patient compliance).
Background summary
At this moment in the Netherlands more than 500.000 people live with the
lasting consequences of Acquired Brain Injury (ABI) as a consequence of
accidents, strokes, tumors or other causes. Each year another 130.000 people
suffer an ABI. For some people the consequences are so severe that
rehabilitation treatment is needed. Up to 97% of patients with ABI who receive
outpatient or inpatient rehabilitation can suffer from impaired self-awareness
of deficits. Patients with impaired self-awareness of deficits have
difficulties understanding their strengths and weaknesses. These patients often
are less motivated to participate in rehabilitation treatments because they do
not see the need for treatment. Partly due to the decreased motivation to
participate in rehabilitation treatments patients show less and/or slower
progress; rehabiltation outcomes for these patients are unfavourable. Still at
this moment rehabilitation settings do not explicitly aim to improve awareness
of deficits. There are no evidence-based interventions for improving awareness
of deficits.
Study objective
The objective of this study therefore is to investigate the clinical effects
and the usability of a new and unique intervention 'nonconfrontational
feedback' for improving awareness of deficits. The intervention given at the
start of (outpatient or inpatient) cognitive rehabilitation of patients with
impaired self-awareness of deficits after ABI.
Study design
A multicenter randomized controlled trial.
There will be seven measurement time points: baseline (T0) before the start of
the cognitive rehabilitation; short-term measurements three weeks (T1) and six
weeks (T2) after T0; and long -term measurements three months (T3), six months
(T4), nine months (T5) and twelve monts (T6) after T0.
Intervention
All patients receive rehabilitation aimed at improving cognitive functioning.
Patients will be randomized over 2 conditions:
1) *Non-confrontational feedback*: this group receives from the start of the
(outpatient or inpatient) cognitive rehabilitation:
- Structured psycho-education abour possible consequences of brain injury for
cogntive functioning, self-awareness of deficits and daily functioning;
- Performance of specific cognitive tasks during the intervention sessions and
in real-life settings and/or virtual reality settings;
- Structured multimodal (verbal, visual and audiovisual) feedback according to
the socalled 'Socratic method' consisting of (as much as possible) positive
reinformcement and non-confrontational discussion between patient and therapist
about how the patient performed a task.
2) *Care as usual: this group receives regular cognitive rehabilitation
including the regular feedback as usual.
Study burden and risks
Patients who participate in the study have the same risks as patients that
receive usual treatment of the consequences of brain injury. Participation in
the study does not lead to additional risks.
The expectation is that the new intervention has a positive effect on
self-awareness of deficits, motivation for rehabilitation treatment,
participation in rehabilitation treatment, quality of life, social
participation and mood.
During the measurements patients are asked to fill out questionnaires (together
with the researcher or the therapist). During the measurements there will be
enough breaks. In general, filling out the questionnaires is not experiences as
stressfull.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
For patients, inclusion criteria are:
- 18 years or older
- indication for (outpatient or inpatient) cognitive rehabilitation
-diagnosed with ABI (e.g. stroke, traumatic brain injury, hypoxia after cardiac
arrest, postoperative brain tumor)
- impaired self-awareness of deficits, based on clinical judgment and score on
Patient Competency Rating Scale and/or Self-Regulation Skills Interview.For
each patient a significant other participates in the study, for filling out a
questionnaire on the patient. Significant others can participate in case they
are 18 years or older.
Exclusion criteria
Patient are excluded in case of:
- no informed consent.
- neurodegenerative disease
- insufficient command of the Dutch language
- aphasia.
- visual impairments (that hinder test assessment)
- patient is still in PTA (GOAT>74).
- premorbid psychiatric conditions / substance abuse for which hospital
admission was needed Significant others cannot participate in case they are not
able to fill out the PCRS due to insufficent command of the Dutch language, or
in case of no informed consentinvull
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62948.068.17 |
| Other | registratie vindt plaats na goedkeuring door de METC |
| OMON | NL-OMON29578 |