Background
Objectives
Methods
Ethical approval and trial registration
Trial design
Inclusion and exclusion criteria
Domain
|
Category
|
---|---|
‘
Managing everyday life
’
| Symptoms management |
Personal care/hygiene | |
Activities of daily living | |
Outdoor mobility and transport | |
‘
Psychosocial
’
| Relationships/communication |
Leisure/holidays | |
Psychological well-being/social role | |
‘
Organization
’
| Information |
Access to services | |
Co-ordination of services | |
Competent professionals |
Recruitment
Informed consent and pre-study evaluation (Visit 0)
Baseline visit (Visit 1)
Randomization
Blinding
HPA group
UC group
Primary outcomes
Secondary outcomes
Baseline
|
Three-month follow-up
|
Six-month follow-up
| |
---|---|---|---|
General characteristics | X | X | X |
MS history | X | X | X |
Medical history | X | X | X |
EDSS | X | X | X |
FIM | X | X | X |
SEIQoL-DW*
| X | X | X |
Core-POS**
| X | X | X |
POS-S-MS**
| X | X | X |
HADS*
| X | X | X |
EQ-5D*
| X | X | X |
MSCQ | X | † | † |
Carer characteristics /medical history | X | X | X |
Carer HADS | X | X | X |
Carer SF-36 | X | X | X |
Carer EQ-5D | X | X | X |
Carer ZBI | X | X | X |
Safety
-
Emergency room visits that do not result in hospital admission
-
Hospitalizations (overnight stay at hospital or emergency room for observation or treatment)
-
Death (any cause)