Remote Investigation and Assessment of Vital Signs

STUDY DESIGN:

A method comparison design with three work packages (WP):

WP1: Focus on estimating validity and reliability of the new study device to measure body temperature.

WP2: Focus on estimating validity and reliability of the new study device to measure all vital signs except body temperature (pulse, systolic and diastolic blood pressure, respiratory rate and oxygen saturation).

WP3: Focus on estimating if there is any difference in the validity and reliability of the new study device to measure all vital signs (except body temperature) in subjects with Fitzpatrick skin type 5-6 as compared with those of skin type 1-4.

STUDY POPULATION:

WP1: Patients aged ≥18 years admitted to or attending a hospital clinic. WP2: Patients aged ≥18 year attending primary health care or patients being admitted to a hospital clinic.

WP3: Individuals aged ≥18 years attending primary health care.

Inclusion criteria

The same subject can't be enrolled more than once with the exception that subjects in WP1 may also be recruited to WP2.

WP1+WP2:

• The patient is attending primary or secondary health care.
• The subject has provided informed consent.
• Age ≥18 years.
• Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
• The patient is willing and able to give informed consent ".
• The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
• The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.

WP3:

• Patients attending primary health care.
• The subject has provided informed consent.
• Age ≥18 years.
• Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
• The patient is willing and able to give informed consent .
• The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
• The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.

Exclusion criteria

Subjects are free to withdraw from the study at any point. Subjects will also be withdrawn from the study in case of unexpected depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes). Any reduction in consciousness will incur that the subject is withdrawn.