Wellness & Workforce Solution for Lupus/Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06217107
• Other study ID #: NOPRODSLE4002
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Morehouse School of Medicine
• Contact: Jan Morgan-Billingslea
• Phone: (404) 756-5713
• Email: jmorgan[@]msm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Behavioral:
• Micro-learning content
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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Morehouse School of Medicine	Janssen Scientific Affairs, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	engagement	frequency counts of app usage and patterns of usage will be combined to report application usage data	Baseline, 3, 6 months
Primary	goal attainment	Health360x application usage data	Baseline, 6 months
Secondary	change in systolic and diastolic blood pressure (mmHg)	Wireless or Universal Serial Bus enabled patient data upload	Baseline, 3, 6 months
Secondary	change in diet	manual entry	Baseline, 6 months
Secondary	change in blood glucose (mg/dL)	Wireless or Universal Serial Bus enabled patient uploads	Baseline, 3, 6 months
Secondary	change in total distance walked daily	Wireless or Universal Serial Bus enabled patient uploads	Baseline, 3, 6 months
Secondary	Health related quality of life	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)	Baseline, 3, 6 months
Secondary	Fatigue	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	Baseline, 3, 6 months
Secondary	Stress Management	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.	Baseline, 3, 6 months
Secondary	Pain will be measured by Brief Pain Inventory - Short Form (BPI-SF)	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.	Baseline, 3, 6 months
Secondary	Depression	Short Form 36 version 2(SF-36v2); scored from 0 (worst health) to 100 (best health)	Baseline, 3 and 6 months
Secondary	self-efficacy	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)	Baseline, 3 and 6 months
Secondary	Depression	Patient Health Questionnaire 9; Total scores of 5, 10, 15, and 20 represent points for mild, moderate, moderately severe and severe depression, respectively.	Baseline, 3 and 6 months
Secondary	self-efficacy	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.	Baseline, 3 and 6 months
Secondary	Depression	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.	Baseline, 3 and 6 months