The objective of this study is to develop, test and evaluate a psychosocial intervention for dialysis patients aimed at better coping with, and reducing fatigue (primary outcome) and thus improving the quality of life (secondary outcome).
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
- Lifestyle issues
Synonym
Health condition
Vermoeidheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: The difference in perceived fatigue between intervention group
and control group (measured with the CIS-fatigue).
(Note: Repeated measures over time (T0t/mT4), within and between groups).
Secondary outcome
Secondary outcome: The difference in perceived quality of life between the
intervention group and control group (measured by the SF-KDQOL).
(Note: Repeated measures over time (T0 t/m T4), within and between groups).
Background summary
The 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
patients* 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.
Study objective
The objective of this study is to develop, test and evaluate a psychosocial
intervention for dialysis patients aimed at better coping with, and reducing
fatigue (primary outcome) and thus improving the quality of life (secondary
outcome).
Study design
Randomized Controlled Trial (RCT): Patients will be randomly assigned to either
the intervention group (psychosocial treatment) or the control group (regular
treatment /no psychosocial treatment).
In this longitudinal 'mixed methods' study both quantitative and qualitative
methods will be applied for data collection (questionnaires (self-report),
observations, interviews, focus groups).
Intervention
Psychosocial treatment (intervention group) VS regular treatment without
psychosocial treatment (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 coping with and reducing
fatigue.
Study burden and risks
To determine the effects of treatment on the short- and long term, repeated
quantitative measurements are conducted (4 x questionnaires over a period of 1
year and 1 month). These questionnaires are completed by the participants in
both the intervention- and control group. To minimize the burdens for patients,
the research team and involved research partners * have critically discussed
the selection of questionnaires (e.g. priority of inclusion and average time to
fill out questionnaires). The members of the Think Tank * will also be asked to
discuss and judge the selected questionnaires. Time to completing the
questionnaires will be kept to a minimum and takes max 60 minutes each
measurement. Participants can decide themselves at what time they fill out the
questionnaires, and whether they do it all at once or at multiple days (within
a maximum of days).
Patients participating in the intervention group are offered 4-6 individual
sessions with a medical social worker. In these sessions different modules
related to fatigue are discussed (+/- 45 min per session). The medical social
worker and the patient assess and decide which modules are appropriate.
Performing some (home)exercises is part of the treatment.
+/- 15 patients who participate in the intervention group will be selected for
an interview in which expectations regarding the treatment and experiences
(after treatment) will be discussed. These interviews take 60-90 minutes. The
interviews will take place at a time and location that suits best for the
patients. Subsequently, 10 patients will be invited for a focus group
discussion to share experiences with treatment and discuss suggestions to
improve the protocol. The duration of this focus group will depend on the
capacity of the participating patients but will not exceed 2.5 hours (including
breaks). The overall duration of the study is one year and four months (for
both participants in the intervention and the control group).
Treatment sessions with a medical social worker, performing exercises and
filling out questionnaires, require certain efforts of patients participating
in this study. However, based on previous studies, we expect that fatigue
levels of patients who receive the treatment will be reduced and perceived
quality of life will increase. If the treatment protocol is proved effective,
the protocol will be made available to hospitals and dialysis centers which are
interested to offer patients a psychosocial treatment to better cope
with/reduce fatigue.
* Two research partners are currently part of the research team. These are
experts in the field of kidney diseases / dialysis (lay knowledge). One of them
is a patient suffering from a kidney disease, one of them is the father of a
patient that has been in dialysis for a long time. Both research partners
participate in research activities and contribute to the quality of the study
and treatment protocol by bringing in the patient perspective/ their lay
knowledge. The Think Tank is a diverse advisory group that monitors the
research from different perspectives. Participants are: patients (members of
the Kidney Patients Association Netherlands - NVN), medical social workers and
nephrologists. The Think Tank contributes to the quality of research and the
quality of the treatment protocol.
Groot Hertoginnelaan 34
Bussum 1405 EE
NL
Groot Hertoginnelaan 34
Bussum 1405 EE
NL
Listed location countries
Age
Inclusion criteria
Kidney 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/move at least 10 minutes with or without supporting device such as a walking stick);
- Are sufficient in Dutch (understanding, conversation, reading) in order to participate in (group)interviews and to fill out Dutch questionnaires.
Exclusion criteria
Patients 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL50975.029.15 |