Clinical Relevance of Scratching and Sleep in Atopic Dermatitis

NCT ID: NCT05467046

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2023-12-07

Brief Summary

Atopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. For evaluating effectiveness and making treatment decisions for these new therapies, only 2 subjective methods exist: 1. clinical scores (AD-severity scored by a physician using structured scoring system), 2. questionnaires (completed by AD-patients). Therefore, an objective AD-severity assessment method might provide benefits for clinical practice.

In this study, it is evaluated whether scratching and sleep parameters, obtained with a smartwatch worn by AD-patients, provide added value for clinical practice in dermatology. The usability of this smartwatch system is evaluated by AD-patients.

Detailed Description

The study consists of two consecutive parts. In part 1, 30 AD-patient will be asked to wear a smartwatch during nighttime and to complete questionnaires regarding the usability of the smartwatch system. In part 2, a focus group with dermatology Health Care Practitioners (HCPs) will take place. In this focus group, the HCPs will evaluate whether the scratching and sleep parameters obtained from the smartwatches worn by the AD-patients in part 1, provide added value for clinical practice in dermatology.

The primary objective is to collect insights in whether objectification of scratching and sleep in AD-patients during the night provides added value for clinical practice in dermatology. The secondary objective is to collect insights into the requirements of AD-patients and dermatology HCPs for a smartwatch system to be acceptable for use in the dermatology clinical practice.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AD-patients

Smartwatch system

Intervention Type: DEVICE

The Atopic Dermatitis patient cohort is exposed to using a smartwatch system for 5 weeks.

Interventions

Smartwatch system

The Atopic Dermatitis patient cohort is exposed to using a smartwatch system for 5 weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has signed informed consent for the BioDay registry and is enrolled in the BioDay registry.
• Patient has a diagnosis of moderate to severe Atopic Dermatitis, and therefore will be treated with advanced systemic treatment in daily practice according to the Dutch AD guideline (after treatment failure of at least 1 oral immunosuppressive drug or a contra-indication for oral immunosuppressive drugs).
• Patient has no concomitant immunosuppressive therapy at baseline
• Age between 18 and 65 years old (18 years ≤ Age ≤ 65 years).
• Intact skin at both wrists (definition of intact skin: Skin in which there are no breaks, scrapes, cuts, or abnormal openings that allow pathogens to enter).
• Willing and able to provide written informed consent and participate in study procedures.
• Able to understand, read and write Dutch.

• HCP is allowed to treat AD-patients
• HCP is (trainee) dermatologist, (trainee) physician, (trainee) research-physician, (trainee) nurse practitioner, (trainee) physician assistant or similar, working in the field of dermatology
• HCP has (digitally) signed consent form for the focus group
• HCP works in a hospital that is a member of the BioDay consortium.

Exclusion Criteria

• Unable to understand instructions
• Expected participation of less than 5 weeks
• Travelling or holiday, for 1 night or more, outside the Netherlands during participation in the study.
• Eczema lesions on one or both wrists at study recruitment
• Patients with neurological disease (e.g., Parkinson's Disease) or physical disability affecting one or both hands, wrist and/or arms.
• Irregular or affected sleep/wake pattern due to causes other than AD. (For example: medical conditions like sleep-apnea or primary insomnia, concomitant medication affecting sleep, alternating shift workers or AD-patients with young infants.)
• Having a tattoo on the upper side of one or both wrists. (Tattoos in the wrist area can cause inaccurate measurements.)
• Institutionalized patients (e.g., care home residents)
• Prisoners (general inmates of prisons or other state institutions)
• Philips research employees
• Study site employees or any other research team member involved directly or indirectly in the conduct of the clinical study
• Cognitively impaired (diagnosis of cognitive impairment in medical file)
• Pregnant persons will not be considered for this study (during pregnancy, the treatment with advanced systemic treatment is not always possible)
• If a patient is not allowed to visit the hospital due to the prevailing COVID-19 restrictions. (If COVID-19 restrictions indicate that it is not allowed to visit the hospital for example when having a positive COVID-19 test, then the patient cannot be included in the study, because it cannot comply with the BioDay study protocol, and thereby indirectly also not with the AD-study protocol).

For dermatology HCPs the eligibility criteria are:

• Unable or unwilling to attend focus group
• Philips Research employees

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

Philips Electronics Nederland B.V. acting through Philips CTO organization

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjolein de Buin-Weller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht (UMC Utrecht)

Locations

University of Utrecht

Utrecht, , Netherlands

Countries

Netherlands

Other Identifiers

ICBE-S-000319

Identifier Type: -

Identifier Source: org_study_id