To gain insight in the agreement and differences between patient and proxy respondents when assessing the health status of the patient en the factors that could be of influence.
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- patient-proxy agreement
- factors that can influence the patient-proxy agreement
Secondary outcome
not applicable
Background summary
There is an increasing use of self-report measurements which are based on the
perspective of the patient. Reliability and validity of the outcomes can be
negatively influenced when patients suffer from, for example, cognitive
impairment. This could also be the case for patients who suffer from Multiple
Sclerosis (MS). A possible solution for this problem might be the incorporation
of a third person, a so-called proxy respondent, who can provide information on
the health status of the patient that otherwise would be inaccurate or even
lost. Previously performed studies on patient-proxy agreement in a small MS
sample indicated that partners might be useful sources of information when
assessing the physical impact of MS. However, large differences were seen on
individual patient-proxy level.
Study objective
To gain insight in the agreement and differences between patient and proxy
respondents when assessing the health status of the patient en the factors that
could be of influence.
Study design
This is a prospective cohort study, which will be performed at the outpatient
clinic of Neurology of the VU Medical Center, Amsterdam. MS patients and their
partners will be asked to participate. Assessments will be scheduled according
to visits that were already planned to limit possible burden. During the
assessments both patients and their partners will complete several
questionnaires, independently from each other. These assessments will be
repeated six months and two years after baseline. At baseline, the patients
will also undergo different tests including a neurological examination,
functional tests and a neuropsychological test battery.
Study burden and risks
MS patients and their partners will have to complete several questionnaires.
Their will be a short-term follow-up at six months and a long-term follow-up
after two years. Assessments will be linked to already planned visits. Patients
will also undergo neurological scoring, tests to assess neurological
functioning and a neuropsychological test battery. To our opinion, the
advantages of possible results outweigh the limited burden that could be
introduced when participating in this study.
De Boelelaan 1118
1081 HZ Amsterdam
NL
De Boelelaan 1118
1081 HZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria patients:
1. Adult (>18 years)
2. Multiple Sclerosis according to McDonald criteria
3. Signed informed consent;Inclusion criteria proxy respondents:
1. Adult (>18 years)
2. Partner of the patient
3. Signed informed consent
Exclusion criteria
Exclusion criteria patients:
1. Severe cognitive impairment which makes it impossible to complete a questionnaire.
2. When the patient does not have a partner;Exclusion criteria proxy respondents:
1. When the proxy respondent is not the partner of the patient
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 | NL23779.029.08 |