FatigueFatHoMNCT04049773
Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study
An observational study of Fatigue and End Stage Renal Disease, run by Zuyderland Medisch Centrum at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, End Stage Renal Disease
- What is being tested?
- haemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 2 sitesNetherlands
- Study dates
- 15 Jul 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: secondary care clinic
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
ZuyderlandMC
Heerlen, Limburg
ZuyderlandMC
Sittard, Limburg
About this 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.
Read the 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).
- Conditions
- Fatigue, End Stage Renal Disease
- Being tested
- haemodialysis
- Keywords
- fatigue, haemodialysis, ecological momentary assessment
- Medical subject headings
- Fatigue, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haemodialysisProcedure or surgery
haemodialysis, thrice weekly in-center
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 consecutive days
Secondary outcomes (3)
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").
Measured: 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.
Measured: 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.
Measured: 7 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start15 Jul 2019
- Primary completion22 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Frank Stifft, MD, Principal investigator, Zuyderland MCCaroline M van Heugten, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049773
- Sponsor's protocol ID
- METCZ20190078
- Acronym
- FatHoM
- Status last verified
- Jul 2019
- First submitted
- 2 Aug 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study
- ClinicalTrials.gov ID
- NCT04049773
- Acronym / sponsor ID
- FatHoM / METCZ20190078
- Conditions
- Fatigue, End Stage Renal Disease
- Keywords
- fatigue, haemodialysis, ecological momentary assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- secondary care clinic
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| haemodialysishaemodialysis, thrice weekly in-center | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
Change in fatigue symptoms (primary outcome) and its association with mood
Time frame: 7 consecutive days
Change in fatigue symptoms (primary outcome) and its association with location, activities and social context
Time frame: 7 consecutive days
Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day
Time frame: 7 consecutive days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Fatigue
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Stifft, MD principal investigator
Zuyderland MC
Caroline M van Heugten, PhD principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and End Stage Renal Disease, run by Zuyderland Medisch Centrum at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue symptoms throughout the day (time frame: 7 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.