Clinical trial NCT06217107: Wellness & Workforce Solution for Lupus/Lupus Nephritis
Official title: [2069264-1] Wellness & Workforce Solution for Lupus and Lupus Nephritis / Janssen Clinical Investigator Initiated Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lupus Nephritis
Keywords: Lupus
Lupus Nephritis
Health360x
Behavioral Intervention
Health coach
Health Literacy
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2024-01-22
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will test the hypothesis that culturally congruent coaching delivered via a technology application (Health360x) will improve the persistent disparities observed among women of color with lupus or lupus nephritis by addressing underlying psychosocial barriers to behavioral change.

Detailed description: The investigators' proposed intervention combines technology with culturally congruent coaching (C3) to increase access and engagement of women of color with lupus through remote instruction. The investigators will test the hypothesis that culturally congruent coaching delivered via a technology application (Health360x) will improve the persistent disparities observed among women of color with lupus or lupus nephritis by addressing underlying psychosocial barriers to behavioral change. The investigators will attain this by connecting patients to extensively trained coaches who have lived experiences that clinicians and providers often lack. These shared social and cultural experiences breeds trust and allows for more open communication that the coach can use to provide more appropriate guidance. Leveraging technology, the investigators' program is asynchronous, promotes engagement and retention of information through micro-learning, and allows the investigators to better understand patient experiences beyond structured surveys by capturing what is happening in the patient-coach relationship.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. females ; Age over 18yo
4. Self-reported diagnosis of Lupus or Lupus Nephritis, or documented diagnosis of Lupus or Lupus Nephritis
5. Willingness to adhere to the study intervention regimen
6. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart-phone, internet access)
7. Not currently practicing self-management behaviors and have not participated in a class or program on self-management behavior within the last 12 months

Adult women with lupus and lupus nephritis will be enrolled in the study. Eligibility: Adult women with lupus and lupus nephritis who are able to consent and participate in self-management support training. Access to the internet is required for this intervention. Ability to read English is required because all the materials are currently in English.

Coaches must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for duration of study
3. Women of color with lupus or lupus nephritis with desire to help others
4. Ability to communicate in English
5. Secure access to Internet
6. Private space for conducting participant visits
7. Ability to use internet-based platform

Exclusion Criteria:

-Potential participants and coaches who are unable to speak or read English, access the internet, or complete data collection activities will be ineligible for participation.

Primary outcomes:
measure: engagement
timeFrame: Baseline, 3, 6 months
measure: goal attainment
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: change in systolic and diastolic blood pressure (mmHg)
timeFrame: Baseline, 3, 6 months
measure: change in diet
timeFrame: Baseline, 6 months
measure: change in blood glucose (mg/dL)
timeFrame: Baseline, 3, 6 months
measure: change in total distance walked daily
timeFrame: Baseline, 3, 6 months
measure: Health related quality of life
timeFrame: Baseline, 3, 6 months
measure: Fatigue
timeFrame: Baseline, 3, 6 months
measure: Stress Management
timeFrame: Baseline, 3, 6 months
measure: Pain will be measured by Brief Pain Inventory - Short Form (BPI-SF)
timeFrame: Baseline, 3, 6 months
measure: Depression
timeFrame: Baseline, 3 and 6 months
measure: self-efficacy
timeFrame: Baseline, 3 and 6 months
measure: Depression
timeFrame: Baseline, 3 and 6 months
measure: self-efficacy
timeFrame: Baseline, 3 and 6 months
measure: Depression
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: MSM Director of Clinical Research Center
name: Priscilla Pemu, MD
role: PRINCIPAL_INVESTIGATOR
References: