FatigueNCT05861492
FDDA Utilization Study (FDDAU)
A study testing Fatigue Differential Diagnosis Aid in people with Fatigue, run by Vifor Pharma, Inc. at 1 site in Switzerland.
Trial summary
This utilization study originally aimed to investigate whether the FDDA could facilitate the differential diagnosis of fatigue and its associated symptoms and consecutively could improve the management and symptoms of fatigue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Fatigue Differential Diagnosis Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Mar 2017to 8 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physicians:
- Established physicians with specialization in general internal medicine (GP).
- Regular consultation of patients with a complaint of a not yet explained fatigue (between 1 every 2 weeks and 5 per week)
- Patients:
- 18 to 80 years old
- Male or female
Show all 9Show fewer
- Fatigue of not yet explained origin
- The reason for encounter had to be fatigue (as a main symptom) of not yet explained origin, which had lasted for at least 2 weeks, but no longer than 2 years before inclusion.
- Subject (or legally acceptable representative) had provided the appropriate written informed consent. Subject had to provide written informed consent before any study-specific procedures were performed.
Who cannot join
- Physicians:
- Works in/or is related to an iron center (a medical center known to be primarily inclined to prescribing intravenous iron supplements in cases of fatigue)
- Known as being experienced in fatigue or CFS (more than five patients per week) Specialized in psychosomatic medicine (in Switzerland: "Fähigkeitsausweis SAPPM / Attestation ASMPP")
- Physicians having a sub-specialty (other than internists working as GPs in a private practice)
- Participation in the feasibility evaluation (excl. for utilization study)
- Patients:
Show all 13Show fewer
- Subject had known pre-existing anemia
- Subject with previous treatment of fatigue by a medical doctor during the last 3 months
- Subject had any pre-known disease, which is responsible for patient's fatigue with a high probability, according to GP's judgement (e.g., CHF, CKD, IBD, RA, MS, Cancer, etc...).
- Subject was known to take any drugs, which could be responsible for inducing fatigue symptoms, according to GP's judgement (e.g., antihistamines, antidepressants, benzodiazepines, hypnotics, anxiolytics, opioid formulations, etc…).
- Subject had a history of drug or alcohol abuse within 2 years prior to the 1st study visit (V1).
- Subject was currently enrolled or had completed any other clinical trial < 30 days prior to 1st study visit (V1).
- Subject had previously participated in the "The Fatigue Differential Diagnosis Aid (FDDA) for General Practitioners: Feasibility study".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Fatigue Differential Diagnosis Aid (FDDA) for General Practitioners: Utilization Study
This utilization study originally aimed to investigate whether the FDDA could facilitate the differential diagnosis of fatigue and its associated symptoms and consecutively could improve the management and symptoms of fatigue. Furthermore, it aimed at investigating the time until diagnosis, the cause of fatigue, the treatment of fatigue, improvement of fatigue symptoms after treatment, the level of satisfaction of the patients resulting from treatment, time until improvement, improvement of subjective general wellbeing, referrals to other medical specialties and number of visits at physician's office because of fatigue.
The planned endpoints, comparing outcomes in patients diagnosed with and without the help of the FDDA were as follows:
Read more
Primary endpoint:
Patient global impression of change (PGIC) at 3 months.
Secondary endpoints:
Patient global impression of change (PGIC) at 6 months; Percentage of patients having experienced a fatigue reduction ≥1 point (NRS); 3 or 6 months after the first visit; Time until an improvement of fatigue ≥1 point (NRS); Mean number of points of fatigue reduction (NRS); Percentage of patients with a PGIC indicating response (=any improvement) after 3 months, 6 months and 3 or 6 months; GP confidence in the established diagnosis; Clinical global impression of change (CGIC); Patient satisfaction of quality of care (diagnosis and treatment); Number of required visits for the same condition; Number of imaging or health services (specialist referrals); required for the diagnosis (MRI, radiograph, etc.); Time to final diagnosis.
Read the detailed description
Fatigue is a frequently encountered problem in medical practice. It becomes clinically relevant when it is out of proportion, i.e., when it is not obviously caused by objective factors (e.g., excessive workload), but rather occurs as an independent subjective phenomenon manifest in the patient her-/himself, rendering the patient less able to perform daily activities or enjoy recreation adequately.
The Sponsor decided to support an effort to facilitate the diagnostic process in the care of patients with symptoms of fatigue. This implied the creation of a decision aid in the form of a questionnaire covering the symptoms and signs of fatigue and the collateral clinical data (Fatigue Differential Diagnosis Aid, FDDA). The project consists of two studies -the Feasibility Study and the Utilization Study. The Feasibility Study preceded the Utilization Study in order to assess the acceptance and handling properties of the instrument that is used in the Utilization Study.
This study aimed to evaluate the effects of the novel Fatigue Differential Diagnostic Aid (FDDA) in clinical practice and its impact on management of fatigue.
Furthermore, it aimed at investigating the time until diagnosis, the cause of fatigue, the treatment of fatigue, improvement of fatigue symptoms after treatment, the level of satisfaction of the patients resulting from treatment, time until improvement, improvement of subjective general wellbeing, referrals to other medical specialties and number of visits at physician's office because of fatigue.
Study Design:
Prospective, randomized, controlled, multicentre with neither treatment intervention nor study drug.
It was conducted in 2 phases:
Phase 1: Data on current practice was collected by GPs, each providing one patient with unexplained fatigue. None of the GPs used the FDDA. These data were planned to characterize the current practice of diagnosis and treatment choice in patients with unexplained fatigue in the whole study population, to compare patients between both groups of GPs before randomization and to establish the factors used for matching the GP in analysis of primary endpoint in phase 2. Together with data from phase 2 the data were planned to be used for intra-group comparisons.
Phase 2: The GPs of phase 1 were randomized to two groups (1:1) with half of the GPs in each group (inter-group comparison):
Group 1 including additional patients without using the FDDA (control group).
Group 2 including additional patients while using the FDDA (experimental group).
Data concerning patient outcome and number of interventions, quality of care and clinical improvement were collected from the patients and from the treating GPs; data collection time points were at V1 (day 0), V2 (month 1), V3 (month 2), V4 (month 3) and V5 (Month 6); data collection was performed via electronic, or paper based CRF.
The steering committee of the study was composed of experts in the field of fatigue (haematologist, psychosomatician, psychiatrists, epidemiologists, geriatrician, internists, and GP).
The study included patients between 18-80 years old, suffering from fatigue (as a main symptom) of not yet explained origin, which had lasted for at least 2 weeks, but no longer than 2 years.
Using questionnaires, data on patients, diagnosis, treatment, and outcomes was collected from physicians and patients collected for the differential diagnosis in unexplained fatigue symptoms.
For those physicians randomized to the FDDA group data from the FDDA itself was collected.
Data was collected by the participating GPs and internists using electronic data capture (eCRFs) or paper forms (CRFs) at first consultation (baseline), and at 1, 2, 3 and 6 months after study enrolment.
It was planned to recruit 144 GPs who would each recruit 1 patient in phase 1 and 3 patients in phase 2, i.e., 144 patients in phase 1 and 432 patients in phase 2, resulting in 576 patients in total.
All endpoints were evaluated based on the intention-to-treat population and repeated for the per-protocol study population. The planned sample size (144 PCP and 432 patients) informed the clustered randomized design and assumed a 15% between-arm difference in binary response, as determined by McNemar's test.
- Conditions
- Fatigue
- Being tested
- Fatigue Differential Diagnosis Aid
- Keywords
- Fatigue, General Practitioner, Differential Diagnosis Aid, PGIC, FDDA, GP
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Differential Diagnosis AidOther
The Fatigue Differential Diagnosis Aid is a systematic questionnaire covering the symptoms and signs of fatigue and the collateral clinical data trying to facilitate the diagnostic process in the care of patient with symptoms of fatigue.
| Study group | Role | What they receive |
|---|---|---|
| FDDA Group | Active comparator | Fatigue anamnesis was done with the help of the Fatigue Differential Diagnosis Aid. Receives: Other: Fatigue Differential Diagnosis Aid |
| Non-FDDA group | No intervention | Fatigue anamnesis was done without the help of the Fatigue Differential Diagnosis Aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGIC 3 months
Patient Global Impression of Change (PGIC) at 3 months. It reflects any change in patient condition.
It consists of 7 grade scale:
"very much improved", "greatly improved", "slightly improved", "no change", "slightly worsened", "greatly worsened", "very much worsened". "Very much improved" being the greater improvement state of the patient condition and "Very much worsened" being the worst change in patient condition.
Measured: 3 months
Secondary outcomes (14)
PGIC 6 months
PGIC: Patient Global Impression of Change. "Very much improved" being the greater improvement state of the patient condition and "Very much worsened" being the worst change in patient's condition) at 6 months.
Measured: 6 months
Fatigue reduction 3 or 6 months
Percentage of patients having experienced a fatigue reduction ≥1 point (NRS), 3 or 6 months after the first visit.
(NRS: Numeric Rating Scale from 0-10, 0 = no tiredness/exhaustion, 10 = extreme tiredness/exhaustion).
Response to comments from PRS reviewer:
We are evaluating whether the FDDA has a positive impact on fatigue reduction. From the statistical perspective, as a secondary endpoint, we were looking at percentage of patients who experienced fatigue improvement by ≥1 point (NRS: Numeric Rating Scale) at 3 or 6 months. Changing this secondary endpoint from "Reduction" to "Change" will represent a different endpoint secondary endpoint.
Measured: 3 or 6 months
Time to improvement
Time expressed by number of days until improvement of fatigue ≥1 point (NRS: Numeric Rating Scale from 0-10, 0 = no tiredness/exhaustion, 10 = extreme tiredness/exhaustion).
Measured: 1 to 6 months
Mean fatigue reduction
Mean number of points of fatigue reduction. (NRS: Numeric Rating Scale from 0-10, 0 = no tiredness/exhaustion, 10 = extreme tiredness/exhaustion)
Measured: 1 to 6 months
PGIC improvement 3 and/or 6 months
Percentage of patients with a PGIC (Patient Global Impression of Change). "Very much improved" being the greater improvement state of the patient condition and "Very much worsened" being the worst change in patient condition) indicating response (=any improvement) at 3 months, 6 months and 3 or 6 months.
Measured: 3 and/or 6 months
GP diagnosis confidence
GP confidence in the established diagnosis. Confidence in the diagnosis expressed by 5 grade scale: "sure", "probable", "possible", "conceivable", "No diagnosis".
Measured: 1 or 3 months
CGIC
Clinical global impression of change (CGIC): 'very much improved' (score=1), 'greatly improved' (score=2), 'slightly improved' (score=3). 'no change' (score=4), 'slightly worsened' (score=5), 'Greatly worsened' (score=6) 'very much worsened' (score=7).
Measured: 1 or 3 months
Patient satisfaction
Patient satisfaction of quality of care (diagnosis and treatment, evaluation scale 5 grades: very dissatisfied, dissatisfied, neutral, satisfied, very satisfied).
Measured: 1 or 3 months
Required visits
Number of required visits for the same condition.
Measured: 1 or 3 months
Specialist referrals
Number of imaging or health services (specialist referrals) required for the diagnosis (MRI, radiograph, etc.).
Measured: 1 to 6 months
Final diagnosis
Time to final diagnosis
Measured: up to 6 months
Physician-reported examinations
Number of laboratory investigations, imaging, and psychological evaluations at baseline
Measured: 1 month and 3 months
Type of diagnosis for fatigue
Type of diagnosis for fatigue at baseline based on the International Classification of Diseases-10 (ICD-10)
Measured: 1 and 3 months
Variety of treatments prescribed for fatigue
No treatment, only iron replacement therapy, iron replacement therapy combined with other treatments, or only other non-iron replacement treatments reported for each patient
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start8 Mar 2017
- Primary completion1 Apr 2021
- Study completion8 Jul 2021
Why it stopped: Recruitment goals could not be met even after amendments to improve recruitment and vast extension of the recruitment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: Data on current practice was collected by GPs, each providing one patient with unexplained fatigue. None of the GPs used the FDDA. Phase 2: The GPs of phase 1 were randomized to two groups (1:1) with half of the GPs in each group. Group 1 including additional patients without using the FDDA (control group). Group 2 including additional patients while using the FDDA (experimental group).
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roland von Kändel, Prof. Dr., Principal investigator, Universitätsspital Zürich, SwitzerlandEdouard Battegay, Prof. Dr., Study chair, Merian Iselin Klinik, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861492
- Sponsor's protocol ID
- VP-NIS-CH-FFDA-U-05.2016
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to share individual participant data with other researchers.
Publications
von Kanel R, Neuner-Jehle S, Kressig RW, Guessous I, Krayenbuhl PA, Zimmerli L, Angelilo-Scherer A, Keller T, Elzner C, Pauls K, Morin N, Battegay E. Effects of a novel differential diagnosis aid for managing patients with unexplained fatigue in primary care: a prospective randomized, controlled, open and multicenter study in primary care. BMC Prim Care. 2025 May 24;26(1):183. doi: 10.1186/s12875-025-02873-3.
PubMed 40413405
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fatigue Differential Diagnosis Aid (FDDA) for General Practitioners: Utilization Study
- ClinicalTrials.gov ID
- NCT05861492
- Acronym / sponsor ID
- VP-NIS-CH-FFDA-U-05.2016
- Conditions
- Fatigue
- Keywords
- Fatigue, General Practitioner, Differential Diagnosis Aid, PGIC, FDDA, GP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment goals could not be met even after amendments to improve recruitment and vast extension of the recruitment period.
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Vifor Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This utilization study originally aimed to investigate whether the FDDA could facilitate the differential diagnosis of fatigue and its associated symptoms and consecutively could improve the management and symptoms of fatigue. Furthermore, it aimed at investigating the time until diagnosis, the cause of fatigue, the treatment of fatigue, improvement of fatigue symptoms after treatment, the level of satisfaction of the patients resulting from treatment, time until improvement, improvement of subjective general wellbeing, referrals to other medical specialties and number of visits at physician's office because of fatigue.
The planned endpoints, comparing outcomes in patients diagnosed with and without the help of the FDDA were as follows:
Primary endpoint:
Patient global impression of change (PGIC) at 3 months.
Secondary endpoints:
Patient global impression of change (PGIC) at 6 months; Percentage of patients having experienced a fatigue reduction ≥1 point (NRS); 3 or 6 months after the first visit; Time until an improvement of fatigue ≥1 point (NRS); Mean number of points of fatigue reduction (NRS); Percentage of patients with a PGIC indicating response (=any improvement) after 3 months, 6 months and 3 or 6 months; GP confidence in the established diagnosis; Clinical global impression of change (CGIC); Patient satisfaction of quality of care (diagnosis and treatment); Number of required visits for the same condition; Number of imaging or health services (specialist referrals); required for the diagnosis (MRI, radiograph, etc.); Time to final diagnosis.
Detailed description
Fatigue is a frequently encountered problem in medical practice. It becomes clinically relevant when it is out of proportion, i.e., when it is not obviously caused by objective factors (e.g., excessive workload), but rather occurs as an independent subjective phenomenon manifest in the patient her-/himself, rendering the patient less able to perform daily activities or enjoy recreation adequately.
The Sponsor decided to support an effort to facilitate the diagnostic process in the care of patients with symptoms of fatigue. This implied the creation of a decision aid in the form of a questionnaire covering the symptoms and signs of fatigue and the collateral clinical data (Fatigue Differential Diagnosis Aid, FDDA). The project consists of two studies -the Feasibility Study and the Utilization Study. The Feasibility Study preceded the Utilization Study in order to assess the acceptance and handling properties of the instrument that is used in the Utilization Study.
This study aimed to evaluate the effects of the novel Fatigue Differential Diagnostic Aid (FDDA) in clinical practice and its impact on management of fatigue.
Furthermore, it aimed at investigating the time until diagnosis, the cause of fatigue, the treatment of fatigue, improvement of fatigue symptoms after treatment, the level of satisfaction of the patients resulting from treatment, time until improvement, improvement of subjective general wellbeing, referrals to other medical specialties and number of visits at physician's office because of fatigue.
Study Design:
Prospective, randomized, controlled, multicentre with neither treatment intervention nor study drug.
It was conducted in 2 phases:
Phase 1: Data on current practice was collected by GPs, each providing one patient with unexplained fatigue. None of the GPs used the FDDA. These data were planned to characterize the current practice of diagnosis and treatment choice in patients with unexplained fatigue in the whole study population, to compare patients between both groups of GPs before randomization and to establish the factors used for matching the GP in analysis of primary endpoint in phase 2. Together with data from phase 2 the data were planned to be used for intra-group comparisons.
Phase 2: The GPs of phase 1 were randomized to two groups (1:1) with half of the GPs in each group (inter-group comparison):
Group 1 including additional patients without using the FDDA (control group).
Group 2 including additional patients while using the FDDA (experimental group).
Data concerning patient outcome and number of interventions, quality of care and clinical improvement were collected from the patients and from the treating GPs; data collection time points were at V1 (day 0), V2 (month 1), V3 (month 2), V4 (month 3) and V5 (Month 6); data collection was performed via electronic, or paper based CRF.
The steering committee of the study was composed of experts in the field of fatigue (haematologist, psychosomatician, psychiatrists, epidemiologists, geriatrician, internists, and GP).
The study included patients between 18-80 years old, suffering from fatigue (as a main symptom) of not yet explained origin, which had lasted for at least 2 weeks, but no longer than 2 years.
Using questionnaires, data on patients, diagnosis, treatment, and outcomes was collected from physicians and patients collected for the differential diagnosis in unexplained fatigue symptoms.
For those physicians randomized to the FDDA group data from the FDDA itself was collected.
Data was collected by the participating GPs and internists using electronic data capture (eCRFs) or paper forms (CRFs) at first consultation (baseline), and at 1, 2, 3 and 6 months after study enrolment.
It was planned to recruit 144 GPs who would each recruit 1 patient in phase 1 and 3 patients in phase 2, i.e., 144 patients in phase 1 and 432 patients in phase 2, resulting in 576 patients in total.
All endpoints were evaluated based on the intention-to-treat population and repeated for the per-protocol study population. The planned sample size (144 PCP and 432 patients) informed the clustered randomized design and assumed a 15% between-arm difference in binary response, as determined by McNemar's test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: Data on current practice was collected by GPs, each providing one patient with unexplained fatigue. None of the GPs used the FDDA. Phase 2: The GPs of phase 1 were randomized to two groups (1:1) with half of the GPs in each group. Group 1 including additional patients without using the FDDA (control group). Group 2 including additional patients while using the FDDA (experimental group).
| Arm | Type | Receives |
|---|---|---|
| FDDA Group | Active comparator | Other: Fatigue Differential Diagnosis AidFatigue anamnesis was done with the help of the Fatigue Differential Diagnosis Aid. |
| Non-FDDA group | No intervention | –Fatigue anamnesis was done without the help of the Fatigue Differential Diagnosis Aid. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Established physicians with specialization in general internal medicine (GP).
- Regular consultation of patients with a complaint of a not yet explained fatigue (between 1 every 2 weeks and 5 per week)
- 18 to 80 years old
- Male or female
- Fatigue of not yet explained origin
Key exclusion criteria (13 listed)
- Works in/or is related to an iron center (a medical center known to be primarily inclined to prescribing intravenous iron supplements in cases of fatigue)
- Known as being experienced in fatigue or CFS (more than five patients per week) Specialized in psychosomatic medicine (in Switzerland: "Fähigkeitsausweis SAPPM / Attestation ASMPP")
- Physicians having a sub-specialty (other than internists working as GPs in a private practice)
- Participation in the feasibility evaluation (excl. for utilization study)
- Subject had known pre-existing anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue Differential Diagnosis AidThe Fatigue Differential Diagnosis Aid is a systematic questionnaire covering the symptoms and signs of fatigue and the collateral clinical data trying to facilitate the diagnostic process in the care of patient with symptoms of fatigue. | Other | FDDA Group |
Primary outcome
PGIC 3 months
Time frame: 3 months
Patient Global Impression of Change (PGIC) at 3 months. It reflects any change in patient condition. It consists of 7 grade scale: "very much improved", "greatly improved", "slightly improved", "no change", "slightly worsened", "greatly worsened", "very much worsened". "Very much improved" being the greater improvement state of the patient condition and "Very much worsened" being the worst change in patient condition.
14 secondary outcomes
PGIC 6 months
Time frame: 6 months
Fatigue reduction 3 or 6 months
Time frame: 3 or 6 months
Time to improvement
Time frame: 1 to 6 months
Mean fatigue reduction
Time frame: 1 to 6 months
PGIC improvement 3 and/or 6 months
Time frame: 3 and/or 6 months
GP diagnosis confidence
Time frame: 1 or 3 months
CGIC
Time frame: 1 or 3 months
Patient satisfaction
Time frame: 1 or 3 months
Required visits
Time frame: 1 or 3 months
Specialist referrals
Time frame: 1 to 6 months
Final diagnosis
Time frame: up to 6 months
Physician-reported examinations
Time frame: 1 month and 3 months
Type of diagnosis for fatigue
Time frame: 1 and 3 months
Variety of treatments prescribed for fatigue
Time frame: 1 and 3 months
Results and safety
The study was stopped early (reason given: Recruitment goals could not be met even after amendments to improve recruitment and vast extension of the recruitment period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 40413405von Kanel R, Neuner-Jehle S, Kressig RW, Guessous I, Krayenbuhl PA, Zimmerli L, Angelilo-Scherer A, Keller T, Elzner C, Pauls K, Morin N, Battegay E. Effects of a novel differential diagnosis aid for managing patients with unexplained fatigue in primary care: a prospective randomized, controlled, open and multicenter study in primary care. BMC Prim Care. 2025 May 24;26(1):183. doi: 10.1186/s12875-025-02873-3.
- Individual participant dataSharing planned: No. It is not planned to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland von Kändel, Prof. Dr. principal investigator
Universitätsspital Zürich, Switzerland
Edouard Battegay, Prof. Dr. study chair
Merian Iselin Klinik, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue Differential Diagnosis Aid in people with Fatigue, run by Vifor Pharma, Inc. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment goals could not be met even after amendments to improve recruitment and vast extension of the recruitment period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGIC 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.