Skip to content

Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04049773
Acronym
FatHoM
Enrollment
42
Registered
2019-08-08
Start date
2019-07-15
Completion date
2019-12-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Fatigue

Keywords

fatigue, haemodialysis, ecological momentary assessment

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).

Interventions

PROCEDUREhaemodialysis

haemodialysis, thrice weekly in-center

Sponsors

Maastricht University
CollaboratorOTHER
Zuyderland Medisch Centrum
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in fatigue symptoms throughout the day7 consecutive daysself-reported fatigue intensity on a 7-point Likert scale (from 1 not fatigued to 7 very fatigued) at ten occasions randomly throughout the day.

Secondary

MeasureTime frameDescription
Change in fatigue symptoms (primary outcome) and its association with mood7 consecutive daysQuestions with respect to mood are evaluated on a 7-point Likert scale (from 1 'not at all to 7very much).
Change in fatigue symptoms (primary outcome) and its association with location, activities and social context7 consecutive daysLocation, social context and activities related questions are provided in a multiple-choice format.
Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day7 consecutive daysSelf-reported intensity of the above-mentioned symptoms on a 7-point Likert scale (from 1 not at all to 7 very much) at ten occasions randomly throughout the day.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026