Assessing Psoriasis Treatment Outcomes: a Single-center, Prospective Study Evaluating Patient Outcomes in Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Ability to implement AIGPP system and Rate of dropout in AIGPP trial arm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Human intervention group
Subjects will receive BD and receive weekly video calls from study staff
干预措施: Human (Behavioral)
AI intervention group
Subject will receive with topical betamethasone dipropionate cream (BD) and have a weekly virtual visit with an AI-generated automated physician provider (AIGPP).
干预措施: Artificial intelligence (Behavioral)
Standard of Care Group
Subjects will receive BD and scheduled for a single follow up visit in 4 weeks
干预措施: Standard of Care (Other)
结局指标
主要结局
Ability to implement AIGPP system and Rate of dropout in AIGPP trial arm
时间窗: Week 4
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
Thematic analysis of qualitative interviews regarding psoriasis patients' attitudes, trust, and comfort levels with AIGPP interactions in a healthcare setting
时间窗: Week 4
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.
次要结局
- Rate of Adherence(Week 4)
- Rate of PASI75, PASI90, PASI100, and IGA of 0 or 1(Baseline, Week 4)
- Rate of adverse events(Week 4)