IMPACT - AndHealth Autoimmune Research Registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: The study population will be composed of AndHealth patients with a documented diagnosis and current use or recommendation for biologic or DMARD medications to treat the autoimmune disorders under study (rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis) and who elect to participate in the outcomes research registry.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

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

Being tested

Root-cause autoimmune treatment program

Medical subject headings

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Root-cause autoimmune treatment programOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline and approximately quarterly thereafter for up to 5 years

2. 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.

   Measured: Baseline and approximately quarterly thereafter for up to 5 years

3. 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.

   Measured: Baseline and approximately quarterly thereafter for up to 5 years

4. 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.

   Measured: Baseline and approximately quarterly thereafter for up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted31 May 2023
2. Study start8 Jun 2023
3. Primary completion22 Nov 2023 (estimated)
4. Study completion22 May 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.