Chronic Fatigue in the Internal Medicine Outpatient Clinic: a Mixed-methods Quantitative and Qualitative Study

NCT06775262 | Recruiting

• 1 other identifier: FlevoziekenhuisNL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

With this study, the investigators aim to answer the following research questions:

1. 1.In what percentage of cases does the diagnostic process conducted during a fatigue consultation at the internal medicine outpatient clinic contribute to a somatic diagnosis?
2. 2.What are the experiences of patients presenting with fatigue at the internal medicine outpatient clinic when a consultation, including diagnostic testing, does not lead to a diagnosis?

Conditions

Fatigue Symptom; Fatigue; Fatigue Syndrome, Chronic

Keywords

Fatigue; Qualitative study; Quantative study; Diagnostic efficacy; Internal medicine; Interviews; Grounded theory

Outcome Measures

Primary Outcomes (4)

• Results of the blood work

  The investigators will determine whether or not pathology is found on the blood work that was done in the context of the fatigue consult. The investigators will determine this on the basis of the conclusion of the internal medicine specialist: Pathology: yes/no.

  The investigators will determine this retrospectively, two weeks time from the time that the patients were seen.

• Results of electrocardiogram (ECG)

  The investigators will determine whether or not pathology is found on the ECG that was done in the context of the fatigue consult. The investigators will determine this on the basis of the conclusion of the cardiologist: Pathology: yes/no.

  The investigators will determine this retrospectively, two weeks time from the time that the patients were seen.

• Results of chest X-ray

  The investigators will determine whether or not pathology is found on the chest X-ray that was done in the context of the fatigue consult. The investigators will determine this on the basis of the conclusion of the radiologist: Pathology: yes/no.

  The investigators will determine this retrospectively, two weeks time from the time that the patients were seen.

• Experiences of fatigue patients visiting an internal medicine outpatient clinic for whom consultation including diagnostics did not bring about a somatic diagnosis brought about through interviews based on Grounded Theory

  These are adult, dutch speaking, native patients, aged 18 to 65 years. They visited the outpatient internal medicine clinic of the Flevoziekenhuis in Almere between the 1st of November 2024 until current.

  The investigators will explore their experiences on two moments: 1-2 months after a consultation and 6 months after a consultation and a year after consultation.

Study Arms (2)

1) Adult patients visiting the internal medicine outpatient clinic for unexplained fatigue.

Specifically the investigators will include adult patients at the above described outpatient clinic with chronic fatigue for whom a consult including diagnostics did not bring about a somatic diagnosis. This cohort is investigated in the context of the retrospective part of this study; investigating the outcome and the efficacy of diagnostics, i.e. an ECG, blood work and a chest X-ray, in patients with fatigue symptoms.

2) Adult patients visiting the internal medicine outpatient clinic for unexplained fatigue.

The investigators will interview patients that have visited the internal medicine outpatient clinic for unexplained fatigue symptoms for whom a consultation including diagnostics did not bring about a somatic diagnosis. The investigators will ask these patients about their experiences shortly after visiting the clinic and 6 months after. This cohort is investigated in the context of the prospective qualitative part of this study. The interviews will have an open character, in accordance with the Grounded Theory methodization.

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

Patients from the Almere region in Flevoland who visit Flevo Hospital Almere for a fatigue consultation. They speak Dutch and are over the age of 18. For the retrospective part of this study, the investigators will exclude patients who visited the clinic during the Covid period (before the 1st of April 2022).

You may qualify if:

• Patients under 18 years of age;
• Patients lost to follow-up.

You may not qualify if:

• Patients at the internal medicine outpatient clinic with a referral for fatigue e.c.i.
• Patients who visited the clinic after the 1st of April 2022.
• Cohort 2:
• Patients at the internal medicine outpatient clinic with a referral for fatigue e.c.i. whose consultation did not bring about a somatic diagnosis
• Patients under 18 years of age;
• Patients that do not speak Dutch fluently

Sponsors & Collaborators

• Flevoziekenhuis: lead

Study Sites (1)

Flevoziekenhuis

Almere Stad, Flevoland, Netherlands

RECRUITING

MeSH Terms

Conditions

Fatigue; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Marije Ten Wolde, MD Phd

  Flevoziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Dahan, Bsc

CONTACT

+31681388354; j.dahan@flevoziekenhuis.nl

Jannes Van der Woude, Bsc

CONTACT

+31655928423; jvdwoude@flevoziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 15, 2025
• Study Start: December 20, 2024
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

NL (1)