Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Fatigue Clinical Trial

— FatHoM  

Official title:

Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049773
• Other study ID #: METCZ20190078
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Fatigue
• Kidney Failure, Chronic

Intervention

Procedure:
• haemodialysis
haemodialysis, thrice weekly in-center

Locations

Country	Name	City	State
Netherlands	ZuyderlandMC	Heerlen	Limburg
Netherlands	ZuyderlandMC	Sittard	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

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