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NCT Number: NCT06217107

Wellness & Workforce Solution for Lupus/Lupus Nephritis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location status: Recruiting

Location contact

Carmel Ibeawuchi, MBA

CONTACT

[email protected]

404-752-1664

Priscilla Pemu, MD MS, FACP

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. engagement

    Time frame: Baseline, 3, 6 months

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

  2. goal attainment

    Time frame: Baseline, 6 months

    Health360x application usage data

Secondary outcomes

  1. change in systolic and diastolic blood pressure (mmHg)

    Time frame: Baseline, 3, 6 months

    Wireless or Universal Serial Bus enabled patient data upload

  2. change in diet

    Time frame: Baseline, 6 months

    manual entry

  3. change in blood glucose (mg/dL)

    Time frame: Baseline, 3, 6 months

    Wireless or Universal Serial Bus enabled patient uploads

  4. change in total distance walked daily

    Time frame: Baseline, 3, 6 months

    Wireless or Universal Serial Bus enabled patient uploads

  5. Health related quality of life

    Time frame: Baseline, 3, 6 months

    Health related quality of life measure in adult lupus 34 items across 8 domains (physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden to others); A mean raw score is transformed to scores ranging from 0 (worst health related quality of life) to 100 (best health related quality of life)

  6. Fatigue

    Time frame: Baseline, 3, 6 months

    Functional assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue); 13-item patient-reported outcome instrument (PRO) that was designed to assess fatigue-related symptoms and impacts on daily functioning; Item scores can range from 0 ("not at all") to 4 ("very much"), and the total score from 0 to 52; lower scores indicate greater fatigue

  7. Stress Management

    Time frame: Baseline, 3, 6 months

    Perceived Stress Scale-4; Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.

  8. Pain will be measured by Brief Pain Inventory - Short Form (BPI-SF)

    Time frame: Baseline, 3, 6 months

    Brief Pain Inventory - Short Form (BPI-SF); Patients are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items or a single item can be treated as the primary outcome measure. A score relating to impact on daily life can be calculated by averaging scores on each of the seven items, which also use scales from 0 to 10. Higher scores indicate greater severity and more interference.

  9. Depression

    Time frame: Baseline, 3 and 6 months

    Short Form 36 version 2(SF-36v2); scored from 0 (worst health) to 100 (best health)

  10. self-efficacy

    Time frame: Baseline, 3 and 6 months

    general practitioner scale (GPS) to reflect specific health activities and content of Health360x Lupus. GPS response categories use a 5-point Likert scale anchored by 1 (strongly agree) and 5 (strongly disagree)

  11. Depression

    Time frame: Baseline, 3 and 6 months

    Patient Health Questionnaire 9; Total scores of 5, 10, 15, and 20 represent points for mild, moderate, moderately severe and severe depression, respectively.

  12. self-efficacy

    Time frame: Baseline, 3 and 6 months

    Health self-efficacy scale; A total score, on a scale of 10 to 40, or a mean scale score, on a scale of 1 to 4, can be calculated. Higher scores indicate higher perceived general self-efficacy, lower scores indicate lower perceived general self-efficacy.

  13. Depression

    Time frame: Baseline, 3 and 6 months

    Patient Health Questionnaire 4; Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Carmel Ibeawuchi, MBA

CONTACT

[email protected]

404-752-1664

Sponsors and collaborators

Lead sponsor

Morehouse School of Medicine

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

[2069264-1] Wellness & Workforce Solution for Lupus and Lupus Nephritis / Janssen Clinical Investigator Initiated Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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