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Assessing Psoriasis Treatment Outcomes

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Begins enrollment in 1 month

Conditions

Psoriasis

Treatments

Behavioral: Artificial intelligence
Behavioral: Human
Other: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07391423
IRB00142799

Details and patient eligibility

About

To assess the feasibility of AIGPP video interactions with psoriasis patients. To explore patient attitudes, trust, and comfort levels concerning AIGPP interactions in a healthcare setting, and to understand their influence on the patient-physician dynamic. To evaluate medication adherence over a 4-week period in patients with psoriasis randomized to weekly AI-generated automated physician providers (AIGPP) video interactions, weekly human video calls, or standard care (single follow up visit after 4 weeks). Adherence rates will be evaluated via a cap designed to record adherence attached to the study medication container.

Full description

Psoriasis is a chronic disease that can negatively impact quality of life. However, adherence to topical treatment for psoriasis can be abysmal. Nonadherence can result in multiple negative effects, including treatment failure, increased healthcare costs, and decreased quality of life. Office visits can drive compliance behavior. By using "white coat compliance," providers increase adherence in the short period before and after a doctor appointment. However, frequent visits may not be feasible for time-constrained healthcare providers. Artificial intelligence (AI) has alleviated provider burden in other settings and may be applied in promoting medication adherence through AI-generated automated physician provider (AIGPP) visits. Given limited funding, this pilot study will assess the feasibility of AIGPP interactions with psoriasis patients treated with betamethasone dipropionate cream (BD).

To accomplish this, up to 15 subjects, age 18 years of age and older, with psoriasis will be recruited to participate. Subjects who meet inclusion criteria will complete a demographic questionnaire and will be randomized to one of three arms (1. AI intervention group - patients will receive BD and have a weekly virtual visit with an AIGPP, 2. human intervention group - patients will receive BD and receive weekly video calls from study staff, 3. standard of care group - patients will receive BD and scheduled for a single follow up visit in 4 weeks). The subjects will receive the BD with a Sensal MyAide adherence device attached.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients ≥18 years of age
  • Patients with a current diagnosis of psoriasis suitable for treatment with topical Betamethasone (BD)
  • Patients who live in the United States
  • Patients with a sufficient command of the English language
  • Patients with a mobile device able to at least operate at 25 frames per second (FPS).

Exclusion criteria

  • Patients less than the age of 18
  • Patients with severe or unstable comorbid conditions
  • Patient who are pregnant or breastfeeding
  • Patients with any other skin conditions that prohibit or confound the ability of the investigator to interpret skin findings
  • Patients that are taking concomitant topical or systemic therapy for the treatment of psoriasis and/or phototherapy
  • Patients without mobile devices able to at least operate at 25 frames per second (FPS).
  • Patients without a current diagnosis of psoriasis suitable for treatment with topical BD

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 3 patient groups

AI intervention group
Experimental group
Description:
Subject will receive with topical betamethasone dipropionate cream (BD) and have a weekly virtual visit with an AI-generated automated physician provider (AIGPP).
Treatment:
Behavioral: Artificial intelligence
Human intervention group
Experimental group
Description:
Subjects will receive BD and receive weekly video calls from study staff
Treatment:
Behavioral: Human
Standard of Care Group
Other group
Description:
Subjects will receive BD and scheduled for a single follow up visit in 4 weeks
Treatment:
Other: Standard of Care

Trial contacts and locations

1

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Central trial contact

Irma M Richardson, MHA

Data sourced from clinicaltrials.gov

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