Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Conditions
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Fatigue, End Stage Renal Disease

Intervention / Treatment
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* Procedure: haemodialysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: haemodialysis|haemodialysis, thrice weekly in-center|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 7very much). | 7 consecutive days | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, haemodialysis, ecological momentary assessment