To compare the quality of life of patients with NMD receiving capability care versus usual care, using a before-after design.
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in the Canadian Occupational Performance Measure (COPM) between both
groups (corrected for the value at baseline).
Secondary outcome
Secondary outcomes:
Difference between both groups in the the ICEpop CAPability measure for Adults
(ICECAP-A), Utrecht Scale for Evaluation of Rehabilitation Participation
(USER-P), the EuroQol-5D-5L (EQ-5D-5L), the Medical Outcome Study Short-Form-36
(SF-36) and the Capability Set for Work Questionnaire (CSWQ) score.
Other study parameters:
Audio recordings of consultations with the healthcare professionals and the
multidisciplinary team meetings, medical reports, questionnaire on resources
and personal characteristics, interviews with patients and partners, focus
groups with healthcare professionals.
Background summary
High quality care of patients with inheritable neuromuscular diseases (NMD)
requires a multi-faceted personalized approach. The capability approach
provides a new conceptualization of wellbeing focusing on a) the real
opportunities that patients have to be and do things they have reason to value
and b) the dynamic interaction between access to resources (e.g., medication,
aids), personal characteristics, physical and social environment, and such
opportunities. In this study we want to investigate whether providing care
based on the capability approach (capability care) has an added value in the
rehabilitation of patients with NMD.
Our research question: What is the effect of capability care on the quality of
life of patients with NMD in comparison with usual care?
Hypothesis: The quality of the lives of adult patients with NMD can be enhanced
by providing capability care in comparison to usual care.
Study objective
To compare the quality of life of patients with NMD receiving capability care
versus usual care, using a before-after design.
Study design
This study will include two groups of thirty adult patients with NMD. The first
group will be provided with optimal care as usual, and followed up for a period
of 6 months. Then, during a period of 3 months, members of the
multidisciplinary care team at Radboudumc will be trained in providing
capability care. Subsequently, the second group will be provided with
capability-centered care, and followed up for a period of 6 months.
Intervention
One group of patients will receive usual rehabilitation care. The other group
of patients will receive care based on the capability approach (capability
care). Health care professionals will be trained to apply the capability
approach in consultation and care to identify a) capabilities of patients and
b) barriers or promoting factors of patients* capabilities. The health
professional learns how to support the patient in thinking about capabilities.
It is expected that one of the main changes is that the consultations will help
patients in reflection on what really matters to them, how their chronic
illness interferes with achieving desired ends, and how the rehabilitation can
help the patient to address this.
Study burden and risks
The participants in the intervention group receive healthcare based on the
capability approach (capability care). It is expected that this type of
healthcare is more person-centred and will lead to a higher quality of life for
patients with neuromuscular disease. The provision of rehabilitation care with
an explicit focus on strengthening patients* capabilities is not expected to
incur greater risk than treatment as usual.
Participants in both the usual care and capability care groups undergo two
measurement moments. Measurement moments contain an interview (1 hour) and
self-report questionnaires (electronically or on paper) (50 minutes). The
interview will take place at the Radboudumc or at a location convenient for the
participant (at home) so that travel time is limited. The measurements are
non-invasive and no health risks are expected. Participants possibly are
confronted with their limitations by the questionnaires or during the
interviews. The research assistants are trained occupational therapists who can
address concerns of participants or advise participants to visit other health
professionals.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
- confirmed diagnosis of FSHD or DM1 by neurologist
- 18 years or older
- a current rehabilitation aim
- in a mentally stable condition
- sufficient mastery of the Dutch language to participate in conversation with
the health care providers and research assistant and to fill in questionnaires
- informed consent (written)
Patients that have been treated previously and have new rehabilitation aims can
be included.
Exclusion criteria
- patients that have one of the following comorbidities:
o active or previously major psychotic, psychiatric or depression episodes
o acquired brain injury (e.g. stroke, traumatic brain injury)
o severe cognitive problems (e.g. severe dementia) in which case the
rehabilitation treatment is affected and/or patients are not able to fill out
the questionnaires
o a limited life expectancy (e.g. due to cancer)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL72794.091.20 |
| OMON | NL-OMON24397 |