A personalized, individual face-to-face program ’Managing Fatigue’ is effective to improve participation in people with FSHD or MM who experience chronic fatigue.
ID
Bron
Verkorte titel
Aandoening
Neuromuscular diseases
Spierziekten
Fascio Scapulo Humeral Dystrophy FSHD
Fascioscapulohumerale dystrofie FSHD
Mitochondrial Myopathy MM
Mitochondriële myopathie MM
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Self-perceived participation measured with the COPM (Canadian Occupational Performance Measure)
Achtergrond van het onderzoek
The Lifebalance study is a randomised clinical trial and evaluates the effectiveness of a personalized, individual face-to-face program ’Managing Fatigue’ to improve participation (Canadian Occupational Performance Measure / COPM) in people with FSHD and MM who experience chronic fatigue in daily life.
Doel van het onderzoek
A personalized, individual face-to-face program ’Managing Fatigue’ is effective to improve participation in people with FSHD or MM who experience chronic fatigue.
Onderzoeksopzet
T0: baseline, before intervention
T1: 3 months after start of intervention
T2: 6 months after start of intervention
T3: 12 months after start of intervention
Onderzoeksproduct en/of interventie
Intervention group
Participants in the intervention group will receive a personalized individual face-to-face program ’Managing Fatigue’ (Packer, Brink et al. 1995). The Program ‘Managing Fatigue’ consists of education, practice, evaluation and implementation of energy conservation strategies in daily life. As occupational therapy is a client centred therapy, the intervention will be tailored to the clients’ individual goals and needs.
Control group
Patients in the control group will not receive any occupational therapy or other therapy treating fatigue problems until their last measurement (12 months after baseline). The control group will receive care as usual.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Diagnosed with FSHD or MM,
- age ≥ 18 years,
- severe fatigue, confirmed by the CIS-Fatigue ≥ 35,
- sufficient mastery of the Dutch language to participate in conversation with the therapist, and
- informed consent (written)
- able to identify, using the COPM, at least three problems in occupational performance that they wish to improve.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- patients with co-morbidity with symptoms that include severe fatigue;
- co-morbidity that interferes with actively taking part in the intervention sessions (e.g. severe psychiatric diagnoses or people with limited life expectancy);
- current involvement in other intervention studies where improvement of fatigue is a possible outcome;
- having received occupational therapy that focused on fatigue management, in the previous twelve months.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7026 |
| NTR-old | NTR7231 |
| CCMO | NL2018-4152 |