Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AndHealth
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Routine Assessment of Patient Index Data 3 (RAPID 3)
研究概览
简要总结
This is a patient research registry aimed at evaluating the effectiveness of a comprehensive, root-cause medical approach ("AndHealth program") for autoimmune disorders. This approach involves a combination of pharmacological and non-pharmacological therapies offered under the care of a licensed physician with the support of health coaches. While protocol guidance is provided, the therapeutic approach is personalized to the individual needs of patients. The autoimmune disorders of focus in this registry include rheumatoid arthritis, psoriatic arthritis, psoriasis and ankylosing spondylitis. A variety of validated labs, patient-reported outcomes, and medication usage will be assessed among participating patients over a period of up to five years to evaluate the long-term effectiveness of this approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 70 years of age
- •Able to understand and write English
- •Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
- •Documented diagnosis and current use/recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis.
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant in the next 12 months
- •Advanced liver or kidney disease
- •Previous organ transplant or awaiting organ transplant
- •Actively being treated for cancer
- •Poorly-controlled mental illness (i.e., schizophrenia, bipolar, current eating disorder)
- •Has a terminal illness
- •Current opioid use
结局指标
主要结局
Routine Assessment of Patient Index Data 3 (RAPID 3)
时间窗: Baseline and approximately quarterly thereafter for up to 5 years
Change in RAPID 3 is a co-primary outcome for rheumatoid arthritis \& psoriatic arthritis patients. All patients with rheumatoid and psoriatic arthritis will provide the RAPID 3 at baseline and all follow-up visits. This 3-item questionnaire is a rheumatological disease activity index that is calculated to reflect severity of disease. Scores range from 0 to 30 with higher scores indicating worse symptoms.
PROMIS - Global Health
时间窗: Baseline and approximately quarterly thereafter for up to 5 years
Change in PROMIS - Global Health is a co-primary outcome for all patients. All patients will provide the PROMIS - Global Health at baseline and all follow-up visits. The 10-item PROMIS Global Health is a patient-reported survey that was designed for use in complex heterogeneous patient populations. The PROMIS Global Health measures overall health status across several physical and mental health areas. PROMIS t-scores range from 16.2 to 67.7 (Physical Health) and 21.2 to 67.6 (Mental Health) with higher scores indicating better health.
Dermatology Life Quality Index (DLQI)
时间窗: Baseline and approximately quarterly thereafter for up to 5 years
Change in DLQI is a co-primary outcome for psoriasis patients. All patients with psoriasis and psoriatic arthritis will provide the DLQI at baseline and all follow-up visits. This 10-item questionnaire is a common measure of the health-related quality of life for skin disorders. DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
时间窗: Baseline and approximately quarterly thereafter for up to 5 years
Change in BASDAI is a co-primary outcome for ankylosing spondylitis patients. All patients with ankylosing spondylitis will provide the BASDAI at baseline and all follow-up visits. This 6-item questionnaires is a brief, validated measure of ankylosing spondylitis activity. BASDAI scores range from 0 to 10, with higher scores indicating worse symptoms.
次要结局
- Disease Activity Score 28 (DAS28)(Baseline and approximately quarterly thereafter for up to 5 years)
- Psoriasis Area and Severity Index (PASI)(Baseline and approximately quarterly thereafter for up to 5 years)
- Patient Health Questionnaire for Anxiety and Depression (PHQ4)(Baseline and approximately quarterly thereafter for up to 5 years)