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van CCT (UK)

van CCT (UK)

Fighting fatigue! An intervention to reduce fatigue.

- candidate number22755
- NTR NumberNTR5366
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-aug-2015
- Secondary IDs2015.049 METc VUmc
- Public TitleFighting fatigue! An intervention to reduce fatigue.
- Scientific TitleMore independent and less tired: the development, execution and evaluation of a psychosocial intervention for renal patients on dialysis
- hypothesisThe objective of this study is to develop, test and evaluate a psychosocial intervention for dialysis patients aimed at reducing fatigue (primary outcome) and improving the quality of life (secondary outcome).
- Healt Condition(s) or Problem(s) studiedEnd-stage renal disease, Dialysis patients, Fatigue
- Inclusion criteriaKidney patients (M / F) who:
- Undergo daytime dialysis (PD, HD, both at home and in the hospital or dialysis center);
- Experience (severe) fatigue;
- Are 18 years or older;
- Are in the ability of physical activity (walk at least 10 minutes with or without supporting device such as a walking stick);
- Are sufficient in Dutch language in order to participate in (group)interviews and to fill out Dutch questionnaires.
- Exclusion criteriaPatients can not participate in the study under circumstances of:
- Participation in other research or treatment aimed at reducing fatigue;
- Treatment by a psychologist or psychiatrist (for severe psychiatric problems such as depression, psychosis, personality disorders or schizophrenia);
- Alcohol or drug addiction.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-jun-2019
- Target number of participants74
- Interventions Psychosocial counseling (intervention group) VS regular treatment without psychosocial counseling (control group). The psychosocial intervention consists of 4-6 individual sessions with a medical social worker (45 min per session) and several practical exercises targeted at better coping with and reducing fatigue.
- Primary outcomeFatigue severity, measured by a sub-scale of the CIS-fatigue.
- Secondary outcomeQuality of Life (kidney disease specific) as measured by the KDQOL.

Questionnaires on coping style (CERQ), illness cognitions/perceptions (ZCL + IPQ-R), catastrophising thoughts (J-FCS), depression (PHQ-9) and overall perceptions of mastery and control (Mastery-scale)are included since these outcomes may be potential moderating or mediating factors.

In addition, various medical parameters and demographics will be studied as potential modifiers.
- TimepointsT0 - base-line (prior to intervention start) T1 - post- treatment ( immediately after the intervention period of 16 weeks) T2 - short term follow up (3 months after the intervention period T3 - long term follow-up (9 months after the intervention period)
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch Kidney Foundation (Nierstichting Nederland)
- Publications
- Brief summaryThe prevalence of (severe) fatigue in dialysis patients ranges between 60 - 97%. Fatigue is a common, subjective and complex phenomenon that has an enormous impact on the (quality of) lives of dialysis patients. Fatigue limits patientsí daily activity levels and independency and is often perceived as a source of stress. Although fatigue is often seen as a side effect of the kidney disease or dialysis treatment, research shows that psychological and environmental factors also affect perceived fatigue. It involves, for example factors such as stress, anxiety, depression, cognitions, coping style, energy-management and social support. Therefore, the treatment of fatigue does not only require a medical, but also a psychosocial approach. Currently, no psychosocial interventions to reduce fatigue in dialysis patients exist, whereas studies on fatigue in cancer, chronic pain, chronic fatigue, brain injury and muscular diseases, suggest that such interventions are effective in reducing fatigue that is caused by multiple (interacting) factors. The objective of this study is to develop, test and evaluate a psychosocial intervention for dialysis patients aimed at reducing fatigue (primary outcome) and improving the quality of life (secondary outcome).
- Main changes (audit trail)
- RECORD17-aug-2015 - 26-aug-2015

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