[2069264-1] Wellness & Workforce Solution for Lupus and Lupus Nephritis / Janssen Clinical Investigator Initiated Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- goal attainment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
C3 Coach plus H360x
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.
干预措施: Health360x app (Behavioral)
C3 Coach plus H360x
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.
干预措施: Culturally congruent coaching (Behavioral)
C3 Coach plus Health360x and micro-learning
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.
干预措施: Health360x app (Behavioral)
C3 Coach plus Health360x and micro-learning
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.
干预措施: Micro-learning content (Behavioral)
C3 Coach plus Health360x and micro-learning
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.
干预措施: Culturally congruent coaching (Behavioral)
结局指标
主要结局
goal attainment
时间窗: Baseline, 6 months
Health360x application usage data
engagement
时间窗: Baseline, 3, 6 months
frequency counts of app usage and patterns of usage will be combined to report application usage data
次要结局
- change in blood glucose (mg/dL)(Baseline, 3, 6 months)
- change in systolic and diastolic blood pressure (mmHg)(Baseline, 3, 6 months)
- Health related quality of life(Baseline, 3, 6 months)
- change in diet(Baseline, 6 months)
- change in total distance walked daily(Baseline, 3, 6 months)
- Fatigue(Baseline, 3, 6 months)
- Stress Management(Baseline, 3, 6 months)
- Pain will be measured by Brief Pain Inventory - Short Form (BPI-SF)(Baseline, 3, 6 months)
- Depression(Baseline, 3 and 6 months)
- self-efficacy(Baseline, 3 and 6 months)