IMPACT - AndHealth Autoimmune Research Registry

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883371
• Other study ID #: 044-AND
• Status: Recruiting
• Start date: June 8, 2023
• Est. completion date: May 22, 2028

Study information

• Verified date: May 2023
• Source: AndHealth
• Contact: Sonja Horner
• Phone: 614-697-3296
• Email: shorner[@]andhealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: May 22, 2028
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adults 18 to 70 years of age

2. Able to understand and write English

3. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

4. Documented diagnosis and current use/recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis.

Exclusion Criteria:

1. Pregnant, breastfeeding, or planning to become pregnant in the next 12 months

2. Advanced liver or kidney disease

3. Previous organ transplant or awaiting organ transplant

4. Actively being treated for cancer

5. Poorly-controlled mental illness (i.e., schizophrenia, bipolar, current eating disorder)

6. Has a terminal illness

7. Current opioid use

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Psoriasis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Root-cause autoimmune treatment program
The AndHealth autoimmune treatment program combines validated and guideline-driven approaches along with emerging evidence-based modalities. The program includes a comprehensive assessment of disease severity, analysis of root causes and comorbidities, and an evaluation of the patient's readiness for implementing important lifestyle changes. This is followed by the development of an optimized and personalized plan to achieve and sustain clinical remission while monitoring their progress. Each patient participating in the AndHealth program receives a personalized care plan developed by the patient's medical provider in collaboration with a team of healthcare specialists. Helping a patient manage everyday lifestyle decisions can have a profound effect on their ability to achieve and maintain remission. The AndHealth Program has organized these into four basic groups of lifestyle behaviors: 1.) Dietary/Nutrition, 2.) Sleep/Circadian, 3.) Stress/HPA axis, and 4.) Physical Activity.

Locations

Country	Name	City	State
United States	AndHealth	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AndHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS - Global Health	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.	Baseline and approximately quarterly thereafter for up to 5 years
Primary	Routine Assessment of Patient Index Data 3 (RAPID 3)	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.	Baseline and approximately quarterly thereafter for up to 5 years
Primary	Dermatology Life Quality Index (DLQI)	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.	Baseline and approximately quarterly thereafter for up to 5 years
Primary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	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.	Baseline and approximately quarterly thereafter for up to 5 years
Secondary	Patient Health Questionnaire for Anxiety and Depression (PHQ4)	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.	Baseline and approximately quarterly thereafter for up to 5 years
Secondary	Disease Activity Score 28 (DAS28)	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.	Baseline and approximately quarterly thereafter for up to 5 years
Secondary	Psoriasis Area and Severity Index (PASI)	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.	Baseline and approximately quarterly thereafter for up to 5 years