Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study
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)