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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI intervention group | Experimental | Subject will receive with topical betamethasone dipropionate cream (BD) and have a weekly virtual visit with an AI-generated automated physician provider (AIGPP). |
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| Human intervention group | Experimental | Subjects will receive BD and receive weekly video calls from study staff |
|
| Standard of Care Group | Other | Subjects will receive BD and scheduled for a single follow up visit in 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial intelligence | Behavioral | patients will receive BD and have a weekly virtual visit with an AIGPP |
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| Measure | Description | Time Frame |
|---|---|---|
| Ability to implement AIGPP system and Rate of dropout in AIGPP trial arm | One primary outcome of the study is the feasibility of AIGPP interactions with psoriasis patients, which will be measured as whether we can create & implement the AIGPP system and the dropout rate in the AIGPP arm | Week 4 |
| Thematic analysis of qualitative interviews regarding psoriasis patients' attitudes, trust, and comfort levels with AIGPP interactions in a healthcare setting | Another primary outcome will be psoriasis patients' attitudes, trust, and comfort levels with AIGPP interactions in a healthcare setting, which will be measured by semi-structured qualitative interviews analyzed via a thematic analysis. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adherence | One secondary outcome is adherence, which will be measured as a continuous variable as the number of days the study medication is used divided by the number of study days. | Week 4 |
| Rate of PASI75, PASI90, PASI100, and IGA of 0 or 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irma M Richardson, MHA | Contact | 336-716-2903 | irma.richardson@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Steven R Feldman, M.D., Ph.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Department of Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010349 | Patient Compliance |
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| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Human | Behavioral | patients will receive BD and receive weekly video calls from study staff |
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| Standard of Care | Other | patients will receive BD and scheduled for a single follow up visit in 4 weeks |
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Another secondary outcome is efficacy, which will be measured as 75% improvement in Psoriasis Area and Severity Index (PASI75), 90% improvement in PASI (PASI90), and 100% improvement in PASI (PASI100). Efficacy will also be measured as the rate of Investigator Global Assessment (IGA) of 0 (clear) and 1 (almost clear)
| Baseline, Week 4 |
| Rate of adverse events | Another secondary outcome will be adverse events, which will be assessed at the study conclusion and will be patient reported. | Week 4 |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |