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

Patients with Chronic Fatigue Complaints for Whom a Consultation Including Diagnostics Do Not Reveal a Somatic Diagnosis Atthe Internal Medicine Outpatient Clinic

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

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. 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?

To address question (1), the investigators will conduct a retrospective data analysis using information from HiX, an electronic health record (EHR) system.

To answer question (2), the investigators will conduct a prospective qualitative study through interviews.

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Fatigue Syndrome, Chronic; Fatigue Symptom

Detailed Description

Chronic fatigue is a prevalent and challenging symptom, affecting an estimated 30% of the general population in the Netherlands for periods longer than six months. Despite its frequency, only a small proportion of patients presenting with fatigue receive a somatic or psychosocial diagnosis, leaving many cases unexplained. This underscores the complexity and subjective nature of fatigue, as well as the need for better understanding and management of this condition in secondary care settings.

The aim of this study is twofold. First, it seeks to determine the effectiveness of diagnostic procedures performed during fatigue consultations at an internal medicine outpatient clinic in contributing to a somatic diagnosis. Second, it aims to explore the experiences of patients for whom these consultations, including diagnostic testing, do not lead to a definitive diagnosis.

This mixed-method study combines quantitative and qualitative approaches. A retrospective analysis of medical records will assess the proportion of fatigue consultations where diagnostics, ie. blood work, an EKG and an X-thorax, result in a somatic diagnosis. Additionally, qualitative interviews will provide insight into the experiences of patients who leave the consultation without a diagnosis. The interviews will have an open characters, based ons principles of "Grounded Theory" (a qualitative research approach that generates theories from data through iterative processes of coding, comparison, and analysis, rather than testing existing hypotheses)

The study will include adult patients referred to an internal medicine outpatient clinic for unexplained fatigue. Data collection will encompass both diagnostic outcomes and patient perceptions, with findings aimed at improving care pathways and diagnostic approaches for individuals with chronic fatigue.

The study will contribute to a deeper understanding of the diagnostic process for fatigue in secondary care and offer insights into the patient experience. This knowledge has the potential to enhance clinical practices and improve patient-centered care for individuals presenting with unexplained fatigue.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jack Dahan, Bsc; Phone Number: +31681388354; Email: j.dahan@flevoziekenhuis.nl
• Study Contact Backup: Name: Jannes Van der Woude, Bsc; Phone Number: +31655928423; Email: jvdwoude@flevoziekenhuis.nl

Study Locations

• Netherlands
  • Flevoland
    • Almere, Flevoland, Netherlands
      • Recruiting
      • Flevoziekenhuis
      • Contact: Marije Ten Wolde, MD PhD; Phone Number: 036 868 8888; Email: MtenWolde@flevoziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Cohort 1:

Inclusion Criteria:

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

Exclusion Criteria:

• 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:

Inclusion criteria

• Patients at the internal medicine outpatient clinic with a referral for fatigue e.c.i. whose consultation did not bring about a somatic diagnosis

Exclusion criteria:

• Patients under 18 years of age;
• Patients that do not speak Dutch fluently

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Flevoziekenhuis
• Investigators: Principal Investigator: Marije Ten Wolde, MD Phd, Flevoziekenhuis

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): July 25, 2025
• Study Completion (Estimated): July 25, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Fatigue; Qualitative study; Internal medicine; Interviews; Diagnostic efficacy; Quantative study; Grounded theory
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Fatigue Syndrome, Chronic; Fatigue
• Other Study ID Numbers: FlevoziekenhuisNL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No