Advanced Unspecific SymptomAID-PM-001NCT07898280
Smartphone-Based Self-Registration of Health Data in Patients With Severe Unspecific Symptoms or Cancer of Unknown Primary
A study testing Smartphone app enabling self-registration of physical and mental health in people with Advanced Unspecific Symptom and Cancer of Unknown Primary Site, run by University of Skövde at 1 site in Sweden.
Trial summary
This study evaluates whether self-registration of health data through a smartphone application can benefit patients undergoing diagnostic evaluation for severe unspecific symptoms (AOS) or cancer of unknown primary (CUP) at the Diagnostic Center of Skaraborg Hospital, Sweden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Unspecific Symptom, Cancer of Unknown Primary Site
- What is being tested?
- Smartphone app enabling self-registration of physical and mental health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2026to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully informed about the nature, scope, and relevance of the study
- Voluntarily agree to participation and having duly signed the Informed Consent Form
- Aged 18 years or older
- Access to and capable of using a regular smartphone (Android or iOS) for study subjects
- referred to the DC at SkaS for diagnostic work-up according to SVF of type AOS or CUP.
Who cannot join
- Participating in another study which may affect the study outcome according to RP's judgement
- Not able to read or understand Swedish
- That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
- For the retrospective cohort only: Deceased
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Skaraborg Hospital
Skövde, 549 49
Christian Scharenberg, PhD MD, +46-500-432166, Christian.scharenberg@vgregion.se
Christian Scharenberg, PhD, MD
About this study
Official title: Understanding and Improving Diagnostic Procedures in Patients With Serious and Non-Specific Symptoms
This study evaluates whether self-registration of health data through a smartphone application can benefit patients undergoing diagnostic evaluation for severe unspecific symptoms (AOS) or cancer of unknown primary (CUP) at the Diagnostic Center of Skaraborg Hospital, Sweden. Approximately 200 to 600 patients will be randomized to either an intervention arm, in which they receive a smartphone application for daily self-registration of physical and mental health, secure communication with care providers, and scheduled health-promoting tasks, or a reference arm receiving care as usual. A secondary retrospective cohort of patients admitted to the Diagnostic Center after December 2021 will be included for comparison. The primary outcome is the perceived benefit of the application to the diagnostic procedure, as judged by care staff. Secondary outcomes include patient empowerment, time to diagnosis, and the ability of artificial intelligence and machine learning methods to stratify patients by severity of underlying disease. Participants will be followed for up to three months, corresponding to the duration of the standard diagnostic work-up. The study is mainly observational; all diagnostic procedures are conducted as part of care as usual.
Read the detailed description
Scientific aim. The aim of the study is to investigate whether self-registration of questionnaire data may benefit patients undergoing diagnostic evaluation for serious and non-specific symptoms, and patients presenting with radiological evidence of a possible malignancy. The study further aims to establish relations between questionnaire data, physical biomarkers, and clinical outcomes in order to improve the diagnostic work-up for this patient group.
Background. Each year, approximately 100 to 200 patients are referred to the Diagnostic Center (DC) at Skaraborg Hospital for examination according to two standardized care pathways (SVF) in Sweden: severe unspecific symptoms (AOS) and cancer of unknown primary (CUP). These patients undergo extensive and resource-intensive diagnostic testing and prolonged investigations. The time required to complete all diagnostic procedures is an additional burden for patients, beyond the symptoms that prompted the referral. Previous research has demonstrated that questionnaire data collected through a smartphone application can support monitoring of health status in patients with alcohol use disorder, where artificial intelligence methods were used to predict patient stability. The present study applies a similar approach, using the Previct Mind application running on the patients' own smartphones, to capture data at home during the initial phase of the diagnostic procedure.
Study design. The study comprises two cohorts. The primary cohort consists of prospectively included patients referred to the DC for diagnostic work-up according to the AOS or CUP care pathways. Participants in the primary cohort are randomized at the first visit to the DC, using consecutively numbered sealed envelopes, to either an intervention arm or a reference arm. Both arms receive care as usual. Participants in the intervention arm receive access to a smartphone application allowing (a) daily self-registration of physical and mental health, (b) assignment of health-promoting tasks by the care provider, (c) secure message-based communication between the patient and the care provider, and (d) a diary function for health-related notes. Simple daily tasks are provided through the application to participants with a low activity level. The reference arm receives care as usual without the application. The secondary cohort consists of retrospective data (biomarker values, diagnostic procedures, diagnosis codes) from patients admitted to the DC after December 2021, and is included to strengthen statistical power for the evaluation of stratification analyses.
Outcomes. The primary outcome is the perceived benefit of the application to the diagnostic procedure, as judged by care staff. Secondary outcomes are: (1) patient empowerment, assessed by questionnaire; (2) time to diagnosis, assessed from medical record data and compared between the intervention arm, the reference arm, and the retrospective cohort; and (3) the ability of artificial intelligence and machine learning methods to stratify patients into groups based on underlying disease severity, using medical history, biomarker panel results, and self-reported physical and mental health. Adverse events associated with data collection and use of the application are recorded as a safety outcome.
Sample size. The primary cohort will comprise at least 200 and at most 600 eligible individuals, with half assigned to the intervention arm. The retrospective cohort will comprise as many patients as can be recruited, with a target of at least 50.
Duration. Each participant in the primary cohort participates for up to three months during the diagnostic procedure at the DC, unless participation is terminated prematurely.
Data management. Data are collected through the Previct Mind system, medical records at Skaraborg Hospital, and questionnaires administered at study visits. The University of Skövde is responsible for compliance with the EU General Data Protection Regulation (GDPR).
Statement of compliance. The study will be conducted in accordance with the ethical principles originating in the Declaration of Helsinki and applicable regional and national regulations. The final study plan, including the final version of the informed consent form, must be approved by an Institutional Ethics Committee before enrollment of any subject.
- Being tested
- Smartphone app enabling self-registration of physical and mental health
- Keywords
- Mobile Health, Early Diagnosis
- Medical subject headings
- Neoplasms, Unknown Primary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone app enabling self-registration of physical and mental healthOther
Also called Previct
The intervention comprises a smartphone app enabling self-registration of physical and mental health. By responding to a brief questionnaire every day, the perceived physical and mental health will be recorded and shared with care provider.
| Study group | Role | What they receive |
|---|---|---|
| Access to app granted | Experimental | Participants in the experimental arm receive access to a smartphone application allowing (a) daily self-registration of physical and mental health, (b) assignment of health-promoting tasks by the care provider, (c) secure message-based communication between the patient and the care provider, and (d) a diary function for health-related notes. Self-registered data is shared with the care provider. Beyond the smartphone application, care as usual is provided. Receives: Other: Smartphone app enabling self-registration of physical and mental health |
| Care as usual | No intervention | Reference group, where care as usual is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived benefit of app-supported self-registration to the diagnostic procedure, as assessed by care staff questionnaire
For each patient in the intervention arm, the treating physician completes a study-specific questionnaire at the conclusion of the diagnostic work-up. The primary reported value is the care staff rating of the extent to which the patient's access to the Previct Mind application influenced decisions made within the diagnostic procedure, on a 5-point ordinal scale where 1 indicates no influence and 5 indicates great influence. Higher scores indicate greater perceived benefit to the diagnostic procedure.
Measured: Upon conclusion of the diagnostic work-up (up to 12 weeks after enrollment)
Secondary outcomes (4)
Patient-rated engagement and empowerment, as assessed by study-specific patient questionnaires
All study subjects (intervention and reference arms) complete a study-specific questionnaire at the conclusion of the diagnostic work-up, rating (a) their engagement in the care received at the Diagnostic Center on a 5-point scale where 1 indicates little engagement and 5 indicates great engagement, and (b) their preference for more or less engagement, on a 5-point scale where 1 indicates a desire for much less engagement and 5 for much more engagement. Higher scores indicate greater perceived engagement and empowerment. Scores are compared between the intervention and reference arms.
Measured: Upon conclusion of the diagnostic work-up (up to 12 weeks after enrollment)
Time from enrollment to concluded diagnosis
Time from enrollment to the concluded diagnosis determined within care as usual, extracted from medical records, compared between the intervention arm, the reference arm, and the retrospective cohort.
Measured: From enrollment to concluded diagnosis (up to 12 weeks after enrollment)
Accuracy of an artificial intelligence or machine learning model in classifying underlying disease severity
An artificial intelligence or machine learning model will be trained on collected data (medical history, biomarker panel results, and self-reported physical and mental health) to classify study subjects as having (1) serious disease warranting referral to the Diagnostic Center, or (2) mild disease not warranting referral. Performance is reported as Area Under the Curve (AUC) of a Receiver-Operator Characteristics (ROC) graph.
Measured: Through study completion, assessed once after all participants have completed the diagnostic work-up.
Incidence and severity of adverse events associated with data collection and use of the smartphone application
Incidence and severity of adverse events associated with data collection and use of the application, including determination of causality. Severity is graded on a 5-point scale ranging from mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated) to death related to the adverse event. Per the protocol, adverse events attributable to this study are anticipated to be mainly limited to privacy infringement, as all medical procedures are conducted as part of care as usual. Incidence and severity of adverse events will be reported in a table.
Measured: From enrollment to completion of the diagnostic work-up (up to 12 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Unspecific SymptomStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Skövde
- Sponsor type
- University, hospital or other
- Collaborators
- Kontigo Care AB, Skillsta Teknik Design och Kvalitet AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898280
- Sponsor's protocol ID
- Dnr 2026-01399-01
- Other IDs
- DNR 250007, Dnr 2026-01399-01
- Acronym
- AID-PM-001
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to researchers outside the primary research group. The study cohort comprises a limited number of patients (at most 600 prospectively included subjects plus a retrospective cohort) investigated at a single diagnostic center in Sweden, for conditions including rare and severe diagnoses such as cancer of unknown primary. In a dataset of this size, the combination of diagnosis codes, biomarker values, demographic variables, and calendar time carries a substantial risk of re-identification of individual participants, which cannot be adequately mitigated through de-identification alone. Sharing is further constrained by obligations under the EU General Data Protection Regulation regarding personal data originating from Swedish health records, and by agreements with the commercial developer of the study application. Aggregated results will be made available through publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Improving Diagnostic Procedures in Patients With Serious and Non-Specific Symptoms
- ClinicalTrials.gov ID
- NCT07898280
- Acronym / sponsor ID
- AID-PM-001 / Dnr 2026-01399-01
- Keywords
- Mobile Health, Early Diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SkövdeUniversity, hospital or other
- Collaborators
- Kontigo Care AB, Skillsta Teknik Design och Kvalitet AB
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 27 Oct 2026 (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 study evaluates whether self-registration of health data through a smartphone application can benefit patients undergoing diagnostic evaluation for severe unspecific symptoms (AOS) or cancer of unknown primary (CUP) at the Diagnostic Center of Skaraborg Hospital, Sweden. Approximately 200 to 600 patients will be randomized to either an intervention arm, in which they receive a smartphone application for daily self-registration of physical and mental health, secure communication with care providers, and scheduled health-promoting tasks, or a reference arm receiving care as usual. A secondary retrospective cohort of patients admitted to the Diagnostic Center after December 2021 will be included for comparison. The primary outcome is the perceived benefit of the application to the diagnostic procedure, as judged by care staff. Secondary outcomes include patient empowerment, time to diagnosis, and the ability of artificial intelligence and machine learning methods to stratify patients by severity of underlying disease. Participants will be followed for up to three months, corresponding to the duration of the standard diagnostic work-up. The study is mainly observational; all diagnostic procedures are conducted as part of care as usual.
Detailed description
Scientific aim. The aim of the study is to investigate whether self-registration of questionnaire data may benefit patients undergoing diagnostic evaluation for serious and non-specific symptoms, and patients presenting with radiological evidence of a possible malignancy. The study further aims to establish relations between questionnaire data, physical biomarkers, and clinical outcomes in order to improve the diagnostic work-up for this patient group.
Background. Each year, approximately 100 to 200 patients are referred to the Diagnostic Center (DC) at Skaraborg Hospital for examination according to two standardized care pathways (SVF) in Sweden: severe unspecific symptoms (AOS) and cancer of unknown primary (CUP). These patients undergo extensive and resource-intensive diagnostic testing and prolonged investigations. The time required to complete all diagnostic procedures is an additional burden for patients, beyond the symptoms that prompted the referral. Previous research has demonstrated that questionnaire data collected through a smartphone application can support monitoring of health status in patients with alcohol use disorder, where artificial intelligence methods were used to predict patient stability. The present study applies a similar approach, using the Previct Mind application running on the patients' own smartphones, to capture data at home during the initial phase of the diagnostic procedure.
Study design. The study comprises two cohorts. The primary cohort consists of prospectively included patients referred to the DC for diagnostic work-up according to the AOS or CUP care pathways. Participants in the primary cohort are randomized at the first visit to the DC, using consecutively numbered sealed envelopes, to either an intervention arm or a reference arm. Both arms receive care as usual. Participants in the intervention arm receive access to a smartphone application allowing (a) daily self-registration of physical and mental health, (b) assignment of health-promoting tasks by the care provider, (c) secure message-based communication between the patient and the care provider, and (d) a diary function for health-related notes. Simple daily tasks are provided through the application to participants with a low activity level. The reference arm receives care as usual without the application. The secondary cohort consists of retrospective data (biomarker values, diagnostic procedures, diagnosis codes) from patients admitted to the DC after December 2021, and is included to strengthen statistical power for the evaluation of stratification analyses.
Outcomes. The primary outcome is the perceived benefit of the application to the diagnostic procedure, as judged by care staff. Secondary outcomes are: (1) patient empowerment, assessed by questionnaire; (2) time to diagnosis, assessed from medical record data and compared between the intervention arm, the reference arm, and the retrospective cohort; and (3) the ability of artificial intelligence and machine learning methods to stratify patients into groups based on underlying disease severity, using medical history, biomarker panel results, and self-reported physical and mental health. Adverse events associated with data collection and use of the application are recorded as a safety outcome.
Sample size. The primary cohort will comprise at least 200 and at most 600 eligible individuals, with half assigned to the intervention arm. The retrospective cohort will comprise as many patients as can be recruited, with a target of at least 50.
Duration. Each participant in the primary cohort participates for up to three months during the diagnostic procedure at the DC, unless participation is terminated prematurely.
Data management. Data are collected through the Previct Mind system, medical records at Skaraborg Hospital, and questionnaires administered at study visits. The University of Skövde is responsible for compliance with the EU General Data Protection Regulation (GDPR).
Statement of compliance. The study will be conducted in accordance with the ethical principles originating in the Declaration of Helsinki and applicable regional and national regulations. The final study plan, including the final version of the informed consent form, must be approved by an Institutional Ethics Committee before enrollment of any subject.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to app granted | Experimental | Other: Smartphone app enabling self-registration of physical and mental healthParticipants in the experimental arm receive access to a smartphone application allowing (a) daily self-registration of physical and mental health, (b) assignment of health-promoting tasks by the care provider, (c) secure message-based communication between the patient and the care provider, and (d) a diary function for health-related notes. Self-registered data is shared with the care provider. Beyond the smartphone application, care as usual is provided. |
| Care as usual | No intervention | –Reference group, where care as usual is provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully informed about the nature, scope, and relevance of the study
- Voluntarily agree to participation and having duly signed the Informed Consent Form
- Aged 18 years or older
- Access to and capable of using a regular smartphone (Android or iOS) for study subjects
- referred to the DC at SkaS for diagnostic work-up according to SVF of type AOS or CUP.
Key exclusion criteria (4 listed)
- Participating in another study which may affect the study outcome according to RP's judgement
- Not able to read or understand Swedish
- That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
- For the retrospective cohort only: Deceased
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 |
|---|---|---|
| Smartphone app enabling self-registration of physical and mental healthAlso: PrevictThe intervention comprises a smartphone app enabling self-registration of physical and mental health. By responding to a brief questionnaire every day, the perceived physical and mental health will be recorded and shared with care provider. | Other | Access to app granted |
Primary outcome
Perceived benefit of app-supported self-registration to the diagnostic procedure, as assessed by care staff questionnaire
Time frame: Upon conclusion of the diagnostic work-up (up to 12 weeks after enrollment)
For each patient in the intervention arm, the treating physician completes a study-specific questionnaire at the conclusion of the diagnostic work-up. The primary reported value is the care staff rating of the extent to which the patient's access to the Previct Mind application influenced decisions made within the diagnostic procedure, on a 5-point ordinal scale where 1 indicates no influence and 5 indicates great influence. Higher scores indicate greater perceived benefit to the diagnostic procedure.
4 secondary outcomes
Patient-rated engagement and empowerment, as assessed by study-specific patient questionnaires
Time frame: Upon conclusion of the diagnostic work-up (up to 12 weeks after enrollment)
Time from enrollment to concluded diagnosis
Time frame: From enrollment to concluded diagnosis (up to 12 weeks after enrollment)
Accuracy of an artificial intelligence or machine learning model in classifying underlying disease severity
Time frame: Through study completion, assessed once after all participants have completed the diagnostic work-up.
Incidence and severity of adverse events associated with data collection and use of the smartphone application
Time frame: From enrollment to completion of the diagnostic work-up (up to 12 weeks after enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to researchers outside the primary research group. The study cohort comprises a limited number of patients (at most 600 prospectively included subjects plus a retrospective cohort) investigated at a single diagnostic center in Sweden, for conditions including rare and severe diagnoses such as cancer of unknown primary. In a dataset of this size, the combination of diagnosis codes, biomarker values, demographic variables, and calendar time carries a substantial risk of re-identification of individual participants, which cannot be adequately mitigated through de-identification alone. Sharing is further constrained by obligations under the EU General Data Protection Regulation regarding personal data originating from Swedish health records, and by agreements with the commercial developer of the study application. Aggregated results will be made available through publication.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone app enabling self-registration of physical and mental health in people with Advanced Unspecific Symptom and Cancer of Unknown Primary Site, run by University of Skövde at 1 site in Sweden.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afrouz Behboudi, Phd, Professor (+46-500-448684, afrouz.behboudi@his.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived benefit of app-supported self-registration to the diagnostic procedure, as assessed by care staff questionnaire (time frame: Upon conclusion of the diagnostic work-up (up to 12 weeks after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.