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Clinical Trials/NCT04049773
NCT04049773CompletedNot Applicable

Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Zuyderland Medisch Centrum1 site in 1 country42 target enrollmentStarted: July 15, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
Change in fatigue symptoms throughout the day

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Change in fatigue symptoms throughout the day

Time Frame: 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 Outcomes

  • Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day(7 consecutive days)
  • Change in fatigue symptoms (primary outcome) and its association with location, activities and social context(7 consecutive days)
  • Change in fatigue symptoms (primary outcome) and its association with mood(7 consecutive days)

Investigators

Sponsor
Zuyderland Medisch Centrum
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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