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Completed

NCT Number: NCT04049773

Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

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.

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Key information

Conditions

Fatigue Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ZuyderlandMC, Heerlen, Limburg, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haemodialysis

Procedure

haemodialysis, thrice weekly in-center

Primary outcomes

  1. 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

  1. Change in fatigue symptoms (primary outcome) and its association with mood

    Time frame: 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").

  2. Change in fatigue symptoms (primary outcome) and its association with location, activities and social context

    Time frame: 7 consecutive days

    Location, social context and activities related questions are provided in a multiple-choice format.

  3. Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Collaborators

  • Maastricht University

Registry information

Acronym: FatHoM

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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