Wellness & Workforce Solution for Lupus/Lupus Nephritis

Not Applicable

Not yet recruiting

• Conditions: Lupus Nephritis
• Interventions: Behavioral: Health360x app; Behavioral: Micro-learning content; Behavioral: Culturally congruent coaching

• Registration Number: NCT06217107
• Lead Sponsor: Morehouse School of Medicine

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.

Study Timeline

• Study First Submitted: 2023-12-08
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Study Start: 2024-06
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C3 Coach plus H360x	Health360x app	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.
C3 Coach plus H360x	Culturally congruent coaching	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.
C3 Coach plus Health360x and micro-learning	Health360x app	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.
C3 Coach plus Health360x and micro-learning	Micro-learning content	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.
C3 Coach plus Health360x and micro-learning	Culturally congruent coaching	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.

Primary Outcome Measures

Name	Time	Method
goal attainment	Baseline, 6 months	Health360x application usage data
engagement	Baseline, 3, 6 months	frequency counts of app usage and patterns of usage will be combined to report application usage data

Secondary Outcome Measures

Name	Time	Method
self-efficacy	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.
change in blood glucose (mg/dL)	Baseline, 3, 6 months	Wireless or Universal Serial Bus enabled patient uploads
change in systolic and diastolic blood pressure (mmHg)	Baseline, 3, 6 months	Wireless or Universal Serial Bus enabled patient data upload
Health related quality of life	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)
change in diet	Baseline, 6 months	manual entry
change in total distance walked daily	Baseline, 3, 6 months	Wireless or Universal Serial Bus enabled patient uploads
Fatigue	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
Stress Management	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.
Depression	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.
Pain will be measured by Brief Pain Inventory - Short Form (BPI-SF)	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.