IMPACT - AndHealth Autoimmune Research Registry

Sponsor

AndHealth (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05883371

Collaborator

(none)

2,500

Enrollment

Location

Anticipated Duration (Months)

41.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid Arthritis, Psoriatic Psoriasis Ankylosing Spondylitis Autoimmune Diseases	Other: Root-cause autoimmune treatment program

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders

Anticipated Study Start Date :

May 22, 2023

Anticipated Primary Completion Date :

Nov 22, 2023

Anticipated Study Completion Date :

May 22, 2028

Outcome Measures

Primary Outcome Measures

PROMIS - Global Health [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.
Routine Assessment of Patient Index Data 3 (RAPID 3) [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.
Dermatology Life Quality Index (DLQI) [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) [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.

Secondary Outcome Measures

Patient Health Questionnaire for Anxiety and Depression (PHQ4) [Baseline and approximately quarterly thereafter for up to 5 years]
Change in PHQ4 is a secondary outcome for all patients. All patients will provide the PHQ4 at baseline and at follow-up visits, as is warranted by scores. This 4-item questionnaire is a common measure of anxiety and depression symptoms. PHQ4 scores range from 0 to 12, with higher scores indicating worse symptoms.
Disease Activity Score 28 (DAS28) [Baseline and approximately quarterly thereafter for up to 5 years]
Change in DAS28 is a secondary outcome for rheumatoid arthritis patients. The DAS28 is a measure of disease activity in rheumatoid arthritis that will be assessed at baseline and all follow-up visits for participants with rheumatoid arthritis. DAS stands for 'disease activity score' and 28 joints are examined in this assessment. DAS28 scores range from 0 to 9.4, with higher scores indicating worse symptoms.
Psoriasis Area and Severity Index (PASI) [Baseline and approximately quarterly thereafter for up to 5 years]
Change in PASI is a secondary outcome for psoriasis and psoriatic arthritis patients. The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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