1. To comprehensively describe: a) the functions, activities, participation, and quality of life of stroke survivors on the short and long term; b) the structure and process of in- and outpatient stroke rehabilitation; c) the stroke patients*…
ID
Source
Brief title
Condition
- Other condition
- Neurological disorders NEC
Synonym
Health condition
CVA
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Functioning (Barthel Index, USER, SIS), activities and participation (CIQ,
USER-P, IPAQ, accelerometry) quality of life (SAQOL-39g, EQ-5D, SF12).
- Patients* perspective: treatment goals and fulfilment of goals (COPM),
satisfaction with stroke care (SASC-19), longer term unmet needs (LUNS),
illness perceptions (IPQ-R), coping (COPE-easy), expectations of treatment
(interviews), self management (PAM-13). Caregiver's perspective: satisfaction
with care (C-SASC), health (RAND36) and caregiver*s strain (CSI).
- Structure ('outline' of treatment) and process (i.e. types, frequency and
content of therapies) of rehabilitation in various centers.
- Costs: rehabilitation costs, health care usage, out of pocket costs,
absenteeism-related costs.
At the 100 months follow-up a new set of questionnaires will be used to assess
long term health status (in particular complications, participation, lifestyle)
and health care usage (in particular medication and walking aids).
Secondary outcome
NA
Background summary
Stroke is a relatively common condition, leading to substantial physical and
cognitive disability in the majority of patients and imposing a considerable
financial burden to society. Rehabilitation is an effective management
strategy, however there is variation between centres with respect to its
structure and process. Patient perspectives and costs of rehabilitative
treatment are understudied, as well as physical activity, selfmanagement and
(the predictors of) long-term participation in society.
Study objective
1. To comprehensively describe: a) the functions, activities, participation,
and quality of life of stroke survivors on the short and long term; b) the
structure and process of in- and outpatient stroke rehabilitation; c) the
stroke patients* satisfaction with treatment, fulfilment of goals, illness
perceptions, coping, longer term unmet needs; d) caregivers* strain and health
and satisfaction with treatment; and e) stroke-related costs for
rehabilitation, health care, and society.
2: To explore differences between two rehabilitation centres in a) structure
and process of treatment; b) patients* satisfaction, c) fulfilment of goals;
and d) costs of treatment.
3: To determine which factors are associated with community participation of
stroke survivors on the long term.
4: To determine long-term health status (in particular complications,
participation, lifestyle) and health care usage (in particular medication and
walking aids) and healthcare needs.
Study design
This project has a multicentre, prospective, observational cohort design and
includes all consecutive in- and outpatients admitted for a stroke in the
Rijnlands Rehabilitation Center Leiden or Alphen a/d Rijn and Sophia
Rehabilitation The Hague, Delft or Zoetermeer. The duration of the study is 7
years in total, with the inclusion period being 4.5 years and the duration of
follow-up being 2.5 years. Questionnaires will be filled in at baseline,
discharge (if applicable) and 3, 6, 12, 18, 24 and 30 months after baseline. An
additional long-term follow-up questionnaire will be sent >4 years.
Study burden and risks
This study is observational in nature with all patients receiving standard
treatment. Assessments mainly consist of questionnaires. There will be no extra
visits to the rehabilitation center for the patients. The study will not impose
any risks to the patients.
The questionnaire of the amendement dd. 05-22 takes 10-20 minutes to complete.
Wassenaarseweg 501
Leiden 2333AL
NL
Wassenaarseweg 501
Leiden 2333AL
NL
Listed location countries
Age
Inclusion criteria
-Time since stroke < 6 months
-Age 18 years or older
-Written informed consent
Exclusion criteria
- Severe psychiatric condition or premorbid dementia
- Impossible to communicatie in the Dutch language
- Drug or alcohol abuse
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL46531.058.13 |