The aim of this study is to investigate the effect of a MSE intervention on social participation and quality of life in chronic stroke patients. This MSE intervention will be compared to a controlgroup in order to measure the additional effect of…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primairily, the effect of MSE on social participation and quality of life will
be measured using the SF-12, EQ 5D, IPA and WhoQol. MSE will be measured using
the MIA. Social participation and quality of life are expected to improve due
to the experimental MSE training.
Secondary outcome
Secondly, the effect of an increase in MSE social participation and quality of
life on memory performance and coping style will be investigated. Memory
performance will be measured using the 15 word test and the two story test from
the RBMT. Coping will be measured using the assimilation-accommodation coping
scale. Furthermore, usage of care will be measured in order to gain insight in
the relation between MSE and the use of care long term after stroke.
Background summary
Metamemory and specifically memory self efficacy (MSE) is well studied in
healthy populations. Several findings indicate that improved MSE has a positive
effect on social participation and quality of life in healthy subjects due to
improved insight in memory functioning. Improved MSE can also enhance memory
performance in this population. MSE is barely studied in stroke and effects of
improved MSE on social participation, quality of life and memory functioning
are not yet established in this population.
Study objective
The aim of this study is to investigate the effect of a MSE intervention on
social participation and quality of life in chronic stroke patients. This MSE
intervention will be compared to a controlgroup in order to measure the
additional effect of MSE training on top of aspecific groupeffects. Increase of
insight in memory functioning is expected to be related to improved social
participation and quality of life. Also, the effects of improved MSE on memory
performance and coping will be investigated.
Study design
The design of the study is a Randomized Controlled Trial blinded for both the
investigator who performs the measures and the participating patient. All
patients will be divided at random between the MSE intervention and the
controlgroup after the first measurement. After the experimental phase,
patients will be measured a week, six months and twelve months after the
grouptraining. MSE, social participation, quality of life, memory performance
and coping will be measured during these sessions.
Intervention
The intervention consists of 10 meetings of an hour, twice a week. The
experimental group is based on a valid method for healthy subjects to improve
MSE through topics as depression, coping and motivation. This training will be
adapted for stroke patients in the first weeks of the study. The control group
consists of fellow sufferers of stroke exchanging experiences under supervision
of an experienced trainer. This group is designed to control for aspecific
groupeffects so the effect of MSE as result of the MSEintervention will be more
clear.
Study burden and risks
There are no risks expected following the participation of this study. The
first weeks of the study are time consuming due to the intervention phase.
There are no physical measurements necessary to participate in the study.
Dr. Molenwaterplein 40
3015 GD Rotterdam
NL
Dr. Molenwaterplein 40
3015 GD Rotterdam
NL
Listed location countries
Age
Inclusion criteria
First and only stroke
A minimum of 18 months post onset
Between 18 and 80 years of age
Capable to handle additional burden of care
Patients have to report memory complaints
independent living
Exclusion criteria
Progressive neurological disorders
Insufficient understanding of the Dutch language
Drug or alcohol abuse
Subarachnoidal haemmorhage, subdural haematoma
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 | NL21004.078.08 |
| OMON | NL-OMON20160 |