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Recruiting NCT06775262

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

Observational Fatigue Symptom Fatigue Fatigue Syndrome, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Fatigue Symptom, Fatigue, Fatigue Syndrome, Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Results of the blood work [Time frame: The investigators will determine this retrospectively, two weeks time from the time that the patients were seen.]
  • Results of electrocardiogram (ECG) [Time frame: The investigators will determine this retrospectively, two weeks time from the time that the patients were seen.]
  • Results of chest X-ray [Time frame: 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 [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Flevoziekenhuis — Almere Stad

Identifiers

NCT: NCT06775262 · FlevoziekenhuisNL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗