The aim of the proposed study is to obtain insight into the needs, functioning and quality of life and changes in these outcomes of people with severe MS who are treated in NU and to identify the experiences, facilitators and barriers using the…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in quality of life, caregivers burden and functional domains from
baseline to endpoint will be evaluated. The primary outcome parameters are the
Euroqol (EQ-5d-5l) and the Adult Social Care Outcome Toolkit (ASCOT) for
respectively health-related- and social related quality of life.
Secondary outcome
1. Disability (meetinstrumenten: Functional independent measure en Multiple
Sclerosis Impact Profile)
2. Caregiver strenght (Caregiver Strain Index)
3. Costs (Medical Consumption Questionnaire)
Background summary
In the current climate of economic rationalization and budget restrictions in
the Dutch health care system, there is an increasing pressure to show the
effects and costs of interventions as part of routine clinical practise. In the
Netherlands, the residential and facility center Nieuw Unicum (NU) delivers
continuous, systematic, long-term multidisciplinary symptomatic treatment for
patients in their later stages of Multiple Sclerosis (MS) and their caregivers.
However, the needs, physical and social well-being of this population have not
been studied in detail. Therefore, it remains unknown whether the health care
services of NU are adequately tailored to the needs of these patients.
Furthermore, the effects in terms of quality of life and functioning and costs
of the health care services provided by NU are unclear. This proposed study is
conducted in a *real world* clinical setting to investigate these remaining
questions.
Study objective
The aim of the proposed study is to obtain insight into the needs, functioning
and quality of life and changes in these outcomes of people with severe MS who
are treated in NU and to identify the experiences, facilitators and barriers
using the health care services of NU. In addition, the costs of the treatments
in NU will be determined.
Study design
The proposed study is a 1.5-year longitudinal observational study with a
mixed-methods design.
Study burden and risks
The treatments are part of regular care given in NU. The participants have to
fill in a set of questionnaires five times in the study period of 18 months.
Filling in the set of questionnaires takes approximately 90 minutes. The
patients will be provided a digital or a paper version depending their
preference.
Most of the items are multiple choice what makes answering more easy for people
with upper extremity disabilities. A pilot showed an increase in fatigue and a
reduced concentration level after completion of the questionnaire. Furthermore,
subjects mentioned the confrontation with their disease as inconvenient.
Filling in the set of questionnaires was found doable in view of duration,
usability and consequences as confrontation with their situation and fatigue.
There are no individually benefits for the participants. To generate more
knowledge about the care for advanced MS patients will be their contribution.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
a referral to Nieuw Unicum and a diagnosis Multiple Sclerosis
Exclusion criteria
Individuals who are mentally incompetent to give informed consent will not be included in the study.
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 | NL62369.029.17 |