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

January 31, 2020 updated by: Zuyderland Medisch Centrum
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands
        • ZuyderlandMC
      • Sittard, Limburg, Netherlands
        • ZuyderlandMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

secondary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 consecutive days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
7 consecutive days
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.
7 consecutive days
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.
7 consecutive days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Collaborators

Maastricht University

Investigators

  • Principal Investigator: Frank Stifft, MD, Zuyderland MC
  • Principal Investigator: Caroline M van Heugten, PhD, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

August 22, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METCZ20190078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue

Clinical Trials on haemodialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe