The quality of life of adult patients with NMD can be enhanced by providing capability care in comparison to usual care.
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Health condition
facioscapulohumeral dystrophy (FSHD) and myotonic dystrophy type 1 (DM1)
Research involving
Sponsors and support
Intervention
- Other 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.
Study objective
The quality of life of adult patients with NMD can be enhanced by providing capability care in comparison to usual care.
Study design
T0: baseline, just before intervention. T1: 6 months after T0
Intervention
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following 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
A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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
IPD sharing statement
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8946 |
| CCMO | NL72794.091.20 |
| OMON | NL-OMON49384 |