Clinical trial NCT04049773: Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study
Official title: Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
End Stage Renal Disease
Keywords: fatigue
haemodialysis
ecological momentary assessment
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2019-08-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: secondary care clinic

Brief summary: To investigate the course and diurnal change of fatigue symptoms and haemodialysis related symptoms in chronic haemodialysis patients, its relation to haemodialysis treatment and the association with other factors by implementing an ecological momentary assessment procedure incorporated in a webapplication.

Detailed description: The course and diurnal change of fatigue symptoms in the daily life of chronic haemodialysis (HD) patients, its relation to haemodialysis treatment and the association with other factors such as mood, activities, location and social context will be evaluated during 7 consecutive days by using an ecological momentary assessment (EMA) procedure, incorporated into a webapplication. Using an EMA procedure will more accurately represent fatigue symptoms and its relation to other factors in the daily life of chronic HD patients compared to conventional measurement instruments (i.e. questionnaires evaluating fatigue over a period of a week or more, which are therefore liable to a recall bias).

Eligibility criteria: Inclusion Criteria:

* End stage renal disease requiring chronic haemodialysis treatment currently being treated for at least 6 months.
* Good understanding of Dutch based on clinical judgment (since the web-application is only available in the Dutch language).

Exclusion Criteria:

* The participant cannot independently handle the web-application based on clinical judgment.
* Dementia or insufficient cognitive skills to handle the web-application based on clinical judgement by the attending physician.

Primary outcomes:
measure: Change in fatigue symptoms throughout the day
timeFrame: 7 consecutive days
Secondary outcomes:
measure: Change in fatigue symptoms (primary outcome) and its association with mood
timeFrame: 7 consecutive days
measure: Change in fatigue symptoms (primary outcome) and its association with location, activities and social context
timeFrame: 7 consecutive days
measure: Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day
timeFrame: 7 consecutive days
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: ZuyderlandMC
state: Limburg
city: Sittard
country: Netherlands
facility: ZuyderlandMC
state: Limburg
Study officials:
affiliation: Zuyderland MC
name: Frank Stifft, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Caroline M van Heugten, PhD
role: PRINCIPAL_INVESTIGATOR
References: