F00 F01 F03 F06.7 F02 G30 G31.8
Conditions
Interventions
Group 1: The objective of Part A (Evaluation study) is to assess attitudes towards the utilisation of a clinical decision support software (CDSS), encompassing aspects such as user-friendliness, desig
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: Part A (Evaluation study) Clinicians - 18 years or older - Ability to provide written informed consent - Actively involved in the diagnostic process for neurodegenerative diseases - Ability to speak and read English fluently Patients - 45 years or older - Underwent diagnostics at the memory clinic - Ability to provide written informed consent - Ability to read and fluently speak the local language or English for study assessments Care partners - 18 years or older - Ability to provide written informed consent - Ability to read and fluently speak the local language or English for study assessments Part B (Validation study) Clinicians - 18 years or older - Ability to provide written informed consent - Actively involved in the diagnostic process for neurodegenerative diseases - Ability to speak and read English fluently Patients - 45 years or older - Underwent diagnostics at the memory clinic - Ability to provide written informed consent - Underwent neuropsychological testing including CERAD/RAVLT word list, TMT A+B, animal fluency within the last six months - Brain MRI available (T1 MPRAGE with slice thickness <1.5mm, T2 FLAIR, T2* or SWI; 1.5 or 3 Tesla), not older than 12 months
Exclusion criteria
Exclusion criteria: Part A and B (Evaluation study and validation study) Patients: - Any major medical condition that according to clinical judgement hinders communication and participation in the study activities, e.g. major psychiatric conditions, alcohol or substance abuse, brain tumors - Impaired ability to provide written informed consent as per clinical judgement according to local standard procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A (Evaluation study): - Clinicians’ opinion on the usefulness of the CDSS and CDSS reports in the diagnostic workflow - Patient and care partner perspectives on the comprehensibility and usefulness of the patient reports Part B (Validation study): - Difference in the diagnostic resources required until final diagnosis and accompanying confidence levels in clinicians, compared between retrospective case readings with and without access to the CDSS | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A (Evaluation study): -CDSS user training success operationalised by performance in post-training test and self-rated satisfaction with training - Clinician, patient and care partner perspective on the design and usefulness of the DMT eligibility report/information about eligibility in the patient report - Attitudes and beliefs of patients and care partners about the use of a CDSS in diagnostic routine Part B (Validation study): - Degree of agreement between the clinicians’ diagnostic decisions with and without access to the tool, including syndrome diagnosis, differential diagnosis and eligibility for DMTs - Degree of agreement between the clinicians’ diagnostic decisions with access to the tool and initial memory clinic diagnosis, including syndrome diagnosis, differential diagnosis and, if available, eligibility for DMTs - Differences in primary and secondary outcomes based on site/country, clinician’s speciality and degree of experience. | — |
Countries
Denmark, Finland, Germany, Netherlands, Norway, Slovenia, Sweden
Outcome results
None listed