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

NCT ID: NCT06775262

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-07-25

Brief Summary

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.

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.

Conditions

Fatigue Symptom; Fatigue; Fatigue Syndrome, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flevoziekenhuis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marije Ten Wolde, MD Phd

Role: PRINCIPAL_INVESTIGATOR

Flevoziekenhuis

Locations

Flevoziekenhuis

Almere Stad, Flevoland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jack Dahan, Bsc

Role: CONTACT

j.dahan@flevoziekenhuis.nl

+31681388354

Jannes Van der Woude, Bsc

Role: CONTACT

jvdwoude@flevoziekenhuis.nl

+31655928423

Facility Contacts

Marije Ten Wolde, MD PhD

Role: primary

MtenWolde@flevoziekenhuis.nl

036 868 8888

Other Identifiers

FlevoziekenhuisNL

Identifier Type: -

Identifier Source: org_study_id