The objective of the present study is to investigate the course of psychosocial functioning in stroke patients and their partners, during the first 2 years post-stroke, to investigate factors predicting psychosocial functioning in stroke patients…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is participation of stroke patients.
Participation will be measured with the Utrecht Scale for Evaluation of
Clinical Rehabilitation - Participation (USER-P).
Secondary outcome
Secondary outcomes of this study are: quality of life, life satisfaction and
emotional functioning of stroke patients and their partners.
These outcomes will be measured with the following measurements:
-Quality of Life will be assessed by two measures. The first measure assesses
stroke health-related quality of life (short Stroke Specific QoL
Questionnaire,SS-QoL-12). The second measure assesses generic health-related
quality of life in terms of utilities (Six Dimension Euro-QoL instrument,
EQ-6D).
-Life Satisfaction will be assessed with three questions which ask for
satisfaction with life before the stroke, now and a comparison between before
and now.
-Emotional functioning will be assessed in terms of depression and anxiety
(Hospital Anxiety and Depression Scale, HADS)
Background summary
In the Netherlands between 34.000 and 41.000 persons suffer a cerebral vascular
accident or stroke each year. Due to the ageing of the population the number of
stroke patients will increase with 27% in the year 2020. Stroke has a high
burden of disease, both for the patients as well as for their partners. After
discharge from hospital, most stroke patients return to their own homes with or
without rehabilitation day treatment, part of them after receiving inpatient
rehabilitation treatment in rehabilitation centres or nursing homes. At home,
care is mostly provided by informal caregivers, mainly spouses, leading to high
levels of caregiver burden. In the long-term particularly psychosocial problems
have a negative impact on social reintegration and quality of life.
Psychosocial problems after stroke, such as depression, fatigue and decreased
levels of social activities of both patients and their informal caregivers are
underestimated and under diagnosed in clinical practice.
Stroke outcome should be studied using an integrated approach addressing the
complex interplay of functional, personal and environmental factors. Cognitive
and emotional consequences have never been studied within this multidomain
perspective; essential information to build a comprehensive prediction model
for patients with cognitive and emotional deficits at risk of long term
participation and QoL problems is currently missing. In addition, the complex
interplay between objective and subjective cognitive functioning needs further
investigation. A new and emerging field is the study of social cognition after
brain injury. Social cognition comprises the capacities of individuals to
understand the behavior of others and to react adequately in social situations.
Impairments in social cognition have been associated with unfavorable outcomes
in terms of return to work and social reintegration in patients with moderate
to severe traumatic brain injury, but has hardly been studied in stroke
patients.
Study objective
The objective of the present study is to investigate the course of psychosocial
functioning in stroke patients and their partners, during the first 2 years
post-stroke, to investigate factors predicting psychosocial functioning in
stroke patients and their partners and to determine the associated economic
implications
Therefore the following research questions will be examined:
1.What is the course of psychosocial functioning (participation, emotional
functioning, life satisfaction and quality of life) in stroke patients and
their partners during the first 2 years post stroke?
2.Which determinants predict the outcome of psychosocial functioning
(participation, emotional functioning, life satisfaction and quality of life)
in stroke patients and their partners 1 and 2 years post stroke?
3.How do patterns of received care after stroke (health care costs,
productivity costs, costs of informal care) change during the time of the
follow-up period of this study and what is their impact in economic terms (cost
of illness study)?
4.How are the costs of received care related to the primary (participation) and
secondary outcome parameters (health-related quality of life, satisfaction and
emotional functioning)?
5. What is the course of cognitive and emotional functioning from the acute
phase until three-four years after stroke?
6. To what extent do stroke patients experience impairments in social cognition
in the long term?
7. Are impairments in cognitive (social cognition included) and emotional
functioning at three-four years after stroke related to participation and QoL
in the long term?
8. What is the course of participation and QoL from two years post stroke until
three-four years post stroke and which factors are related to change?
Study design
This is a multi-centre prospective cohort study, with 6 assessments.
The first assessment will take place during the first week post-stroke (during
the hospital stay). The other assessments will take place at 2 months, 6
months, 1 year, 2 years and 3-4 years post-stroke.
We expect to test 250 patients at the added assessment 3-4 years post-stroke,
based on the low drop-out rate so far.
Study burden and risks
During a 3 to 4 year follow-up cohort study participants (patients and their
partners) will complete six assessments. For the patient the first assessment
wil be part of care as usual and means therefore no effort and achievement for
the patient. Only the partner of the patient has to fill in a premorbid
participation questionnaire, which only will cost 5 minutes.
The second and third assessment of the patient will consist of questionnaires,
a cognitive test, an interview of 10 minutes, and two observation measures. The
cognition and observation measures will be filled in by a trained research
assistent, who will visit the patient in the hospital, during the after care
polyclinic, or where the patient is residing at that moment, such as home or in
a rehabilitation center.
The fourth and fifth assessment of the patient will only consist of
questionnaires. For the partner all five assessments consist only of
questionnaires.
The sixth assessment of the patient consists of a neuropsychological testing
battery and some questionnaires.
At assessment 2 and 3 part of the questionnaires will be sent to the patient
and his/her partner. The research assistent will check if there are any
questions of missing values during her visit. At the end of the visit the
research assistent will give the patient and his/her partner the rest of the
questionnaires. When all the questionnaires are filled in, they can be sent
back to the researcher. The patient and his/her partner can fill in the
questionnaires independently and at their own pace. Furthermore, the
questionnaires can be filled in at different times, when it is too wearisome to
fill them in at one moment.
At assessment 4 and 5 all questionnaires are sent to the patient and his/her
partner. When all the questionnaires are filled in, the patient and his/her
partner can send them back to the researcher. Just like assessment 2 and 3, the
patient and his partner can fill in the questionnaires independently and at
their own pace.
Assessment 6 consists of a neuropsychological testing battery and will
preferably take place at the hospital and will take about 1 hour. When the
patient is unable to visit the hospital, the research assistent will visit
him/her at home. Furthermore, the questionnaires will be filled in by the
patient.
There are no known risks for partcipating in this study.
Rembrandtkade 10
Utrecht 3583 TM
NL
Rembrandtkade 10
Utrecht 3583 TM
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria patient:
1). Symptomatic stroke (ischemic or intracerebral haemorrhagic lesion), if possible verified by CT and/or MRI scan.
2). Age at least 18 years.
3). Written informed consent. ;inclusion criteria partner:
1). The partner must be married or live together with the patient.
2). The partner (patient) must participate in the study.
Exclusion criteria
Exclusion criteria patient:
1). Insufficient command of the Dutch language in order to participate and understand questionnaires, based on clinical judgement.
2). Pre-existent dependence in activities of daily living as defined by a pre-morbid Barthel Index below 18.
3.) pre-existent cognitive decline as defined by a score of 1 or higher on the HAC (Heteroanamnesis List Cognition).
4). Co-morbidity: A serious condition whereby an interference with the outcomes of the study is expected, (such as a psychiatric disorder whereby a person is under supervision of a psychiatrist or a serious cardiac disease), or a disease with a progressive course (such as cancer, arthritis, multiple sclerosis, dementia) or a life-threatening condition resulting in a life expectancy less than 6 months (such as a high risk of death from stroke or terminal kidney insufficiency).;Exclusion criteria partner:
1). Insufficient command of the Dutch language in order to participate and understand questionnaires, based on clinical judgement.
2). Pre-existent dependence in activities of daily living as defined by a pre-morbid Barthel Index below 18.
3). Co-morbidity: A serious condition whereby an interference with the outcomes of the study is expected, (such as a psychiatric disorder whereby a person is under supervision of a psychiatrist or a serious cardiac disease), or a disease with a progressive course (such as cancer, arthritis, multiple sclerosis, dementia) or a life-threatening condition resulting in a life expectancy less than 6 months (such as a high risk of death from stroke or terminal kidney insufficiency).
Design
Recruitment
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 | NL34676.100.10 |