Health TrialsbyHealthPanel

Wellness & Workforce Solution for Lupus/Lupus Nephritis

ConditionLupus Nephritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMorehouse School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: C3 Coach plus H360xExperimental treatment 2 interventions
Group B: C3 Coach plus Health360x and micro-learningActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

engagement

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

Time frame
Baseline, 3, 6 months
2

goal attainment

Health360x application usage data

Time frame
Baseline, 6 months

Secondary outcomes

1

change in systolic and diastolic blood pressure (mmHg)

Wireless or Universal Serial Bus enabled patient data upload

Time frame
Baseline, 3, 6 months
2

change in diet

manual entry

Time frame
Baseline, 6 months
3

change in blood glucose (mg/dL)

Wireless or Universal Serial Bus enabled patient uploads

Time frame
Baseline, 3, 6 months
4

change in total distance walked daily

Wireless or Universal Serial Bus enabled patient uploads

Time frame
Baseline, 3, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Morehouse School of Medicine

Lead sponsor

Janssen Scientific Affairs, LLC

Collaborator

Source ClinicalTrials.gov
Apply now