Wellness & Workforce Solution for Lupus/Lupus Nephritis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 rela
• Поведенческое 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 t
• Поведенческое 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.

Первичные конечные точки

• engagement [Срок оценки: Baseline, 3, 6 months]
• goal attainment [Срок оценки: Baseline, 6 months]

Вторичные конечные точки (12)

• change in systolic and diastolic blood pressure (mmHg) [Срок оценки: Baseline, 3, 6 months]
• change in diet [Срок оценки: Baseline, 6 months]
• change in blood glucose (mg/dL) [Срок оценки: Baseline, 3, 6 months]
• change in total distance walked daily [Срок оценки: Baseline, 3, 6 months]
• Health related quality of life [Срок оценки: Baseline, 3, 6 months]
• Fatigue [Срок оценки: Baseline, 3, 6 months]
• Stress Management [Срок оценки: Baseline, 3, 6 months]
• Pain will be measured by Brief Pain Inventory - Short Form (BPI-SF) [Срок оценки: Baseline, 3, 6 months]
• Depression [Срок оценки: Baseline, 3 and 6 months]
• self-efficacy [Срок оценки: Baseline, 3 and 6 months]
• Depression [Срок оценки: Baseline, 3 and 6 months]
• self-efficacy [Срок оценки: Baseline, 3 and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

-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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Morehouse School of Medicine — Atlanta

Идентификаторы

NCT: NCT06217107 · NOPRODSLE4002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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