Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Completed

• Conditions: Fatigue; End Stage Renal Disease

• Registration Number: NCT04049773
• Lead Sponsor: Zuyderland Medisch Centrum

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).

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-15
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Primary Completion: 2019-08-22
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in fatigue symptoms throughout the day	7 consecutive days	self-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 Outcome Measures

Name	Time	Method
Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day	7 consecutive days	Self-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.
Change in fatigue symptoms (primary outcome) and its association with location, activities and social context	7 consecutive days	Location, social context and activities related questions are provided in a multiple-choice format.
Change in fatigue symptoms (primary outcome) and its association with mood	7 consecutive days	Questions with respect to mood are evaluated on a 7-point Likert scale (from 1 '"not at all" to 7"very much").

Trial Locations

Locations (1)

ZuyderlandMC; 🇳🇱 Sittard, Limburg, Netherlands