Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

NCT04049773 | Completed

• 1 other identifier: METCZ20190078
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Fatigue; End Stage Renal Disease

Keywords

fatigue; haemodialysis; ecological momentary assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  7 consecutive days

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

  7 consecutive days

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

  7 consecutive days

Interventions

haemodialysis PROCEDURE

haemodialysis, thrice weekly in-center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

secondary care clinic

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Maastricht University: collaborator

Study Sites (2)

ZuyderlandMC

Heerlen, Limburg, Netherlands

Location

ZuyderlandMC

Sittard, Limburg, Netherlands

Location

MeSH Terms

Conditions

Fatigue; Kidney Failure, Chronic

Interventions

Dialysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Frank Stifft, MD

  Zuyderland MC

  PRINCIPAL INVESTIGATOR

• Caroline M van Heugten, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 8, 2019
• Study Start: July 15, 2019
• Primary Completion: August 22, 2019
• Study Completion: December 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)