Wellness & Workforce Solution for Lupus/Lupus Nephritis

NCT06217107 | Unknown

• 1 other identifier: NOPRODSLE4002
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lupus Nephritis

Keywords

Lupus; Lupus Nephritis; Health360x; Behavioral Intervention; Health coach; Health Literacy

Outcome Measures

Primary Outcomes (2)

• engagement

  frequency counts of app usage and patterns of usage will be combined to report application usage data

  Baseline, 3, 6 months

• goal attainment

  Health360x application usage data

  Baseline, 6 months

Secondary Outcomes (13)

• change in systolic and diastolic blood pressure (mmHg)

  Baseline, 3, 6 months

• change in diet

  Baseline, 6 months

• change in blood glucose (mg/dL)

  Baseline, 3, 6 months

• change in total distance walked daily

  Baseline, 3, 6 months

• Health related quality of life

  Baseline, 3, 6 months

Study Arms (2)

C3 Coach plus H360x

EXPERIMENTAL

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.

Behavioral: Health360x app; Behavioral: Culturally congruent coaching

C3 Coach plus Health360x and micro-learning

ACTIVE COMPARATOR

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.

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

Interventions

Micro-learning content BEHAVIORAL

This is a series of modules designed to provide disease education, additional communication through 'push notifications,' promote self-management, and medication adherence in women of color with lupus and lupus nephritis. Leveraging technology, this 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.

C3 Coach plus Health360x and micro-learning

Health360x app BEHAVIORAL

The coach and participant will use problem-solving tools embedded in Health360x to map out potential barriers to goal attainment and create goal action plans. This application has the potential to help improve health-related quality of life, and reduce morbidity and mortality associated with Lupus. The intervention also tests the role of health coaches in the lupus ecosystem. The potential economic gain and impact on more extant social determinants of health can create long ranging benefits on the health and wellbeing of the community.

C3 Coach plus H360x; C3 Coach plus Health360x and micro-learning

Culturally congruent coaching BEHAVIORAL

The coaching process includes specified visits over the course of our proposed 6-month intervention. These visits will occur remotely using HIPAA compliant video conferencing tools or in person when it is safe and convenient to meet in person. Overall, the coaches will work with Lupus patients to facilitate experiential learning, improve functioning and performance in the context of working towards specific goals.

C3 Coach plus H360x; C3 Coach plus Health360x and micro-learning

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women of color with lupus and lupus nephritis
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• females ; Age over 18yo
• Self-reported diagnosis of Lupus or Lupus Nephritis, or documented diagnosis of Lupus or Lupus Nephritis
• Willingness to adhere to the study intervention regimen
• Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart-phone, internet access)
• 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:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for duration of study
• Women of color with lupus or lupus nephritis with desire to help others
• Ability to communicate in English
• Secure access to Internet
• Private space for conducting participant visits

You may not qualify if:

• 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.

Sponsors & Collaborators

• Morehouse School of Medicine: lead
• Janssen Scientific Affairs, LLC: collaborator

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Priscilla Pemu, MD

  MSM Director of Clinical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Morgan-Billingslea

CONTACT

(404) 756-5713; jmorgan@msm.edu

Dana Kajan, DO

CONTACT

(404) 752-1166; dkajan@msm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 22, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01