Wellness & Workforce Solution for Lupus/Lupus Nephritis

Morehouse School of Medicine

Status: Not yet enrolling

Conditions: Lupus Nephritis

Treatments: Behavioral: Micro-learning content; Behavioral: Culturally congruent coaching; Behavioral: Health360x app

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06217107

NOPRODSLE4002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

C3 Coach plus H360x

Experimental group

Description:

Arm 1 will have 80 participants who will receive four weekly goal setting sessions with coach consisting of 45 min-1 hour recorded sessions. They will then receive another 4 sessions every 2 weeks, followed by three monthly goal setting sessions. Baseline surveys will be collected, in addition to surveys taken at 3 and 6 months.

Treatment:

Behavioral: Culturally congruent coaching

Behavioral: Health360x app

C3 Coach plus Health360x and micro-learning

Active Comparator group

Description:

Arm 2 will have 80 participants who will receive four weekly goal setting sessions with coach consisting of 45 min-1 hour recorded sessions, in addition to periodic micro-learning content delivered via an online technology platform. They will then receive another 4 sessions every 2 weeks, followed by three monthly goal setting sessions. Baseline surveys will be collected, in addition to surveys taken at 3 and 6 months. This arm will have learning augmented by micro-learning to test effectiveness in enhancing engagement and promoting retention of educational content.

Treatment:

Behavioral: Micro-learning content

Behavioral: Culturally congruent coaching

Behavioral: Health360x app