Background
Methods/Design
Design and setting
Research team and advisory group
Research team
Advisory group
Patient recruitment
Sample size
Inclusion criteria
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Adult patients (age ≥ 18), male or female, who undergo day dialysis (haemodialysis (HD), Peritoneal Dialysis (PD), at home, a hospital or a dialysis centre);
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Experiencing (severe) fatigue (score CIS-fatigue scale ≥ 35);
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Being able to walk/move for at least 10 min with or without a supporting device such as a walking stick;
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Having a sufficient understanding of the Dutch language in order to participate in counselling, (group) interviews and fill out the questionnaires adequately.
Exclusion criteria
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Dialysis during the night (since it is assumed that patients on day dialysis experience more severe fatigue compared to patients on night dialysis);
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Participation in other studies or treatments aimed at reducing fatigue;
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Treatment by a psychologist or psychiatrist (for severe psychiatric problems such as depression, psychosis, personality disorders or schizophrenia);
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Alcohol or drug addiction.
Randomisation
Study intervention
Usual care versus psychosocial intervention
Intervention protocol
Intervention instruction for social workers
Intervention procedures
Data collection and management
Quantitative measurements
Instrumentation | T0 | T1 | T2 | T3 | |
---|---|---|---|---|---|
Primary outcome measures | |||||
Fatigue severity | Checklist Individual Strength (CIS-fatigue) [43] | x | x | x | x |
Secondary outcome measures | |||||
Quality of life | Kidney Disease and Quality of Life Short Form (KDQOL-SF) [48] | x | x | x | x |
Mediating/moderating variables | |||||
Social support | x | x | x | x | |
Illness cognitions | Illness Cognition Questionnaire (ICQ) [60] | x | x | x | x |
Illness perceptions | Illness Perception Questionnaire (IPQ-R) [61]: subscale emotional representation | x | x | x | x |
Coping | Cognitive Emotion Regulation Questionnaire (CERQ) [62] | x | x | x | x |
Catastrophizing thoughts | x | x | x | x | |
Mastery | Mastery Scale [65] | x | x | x | x |
Depression | Patient Health Questionnaire: Depression (PHQ-9) [66] | x | x | ||
General effect modifiers | |||||
Demographic variables | Self-report: age, gender, education, ethnicity, social status, employment | x | |||
Medical history and comorbidity | Self-report: treatment, treatment frequency, transplantability | x | |||
Medical parameters | Medical records: sleep medication, Epo, Hb, Urea, Creatinine, Protein, Albumin, CRP, weight, height | x | x |