Learning to THRIVE (L2T) Program Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Participants Enrolled During the Recruitment Period
研究概览
简要总结
This pilot study evaluated the feasibility and potential effects of Learning to THRIVE (L2T), a six-week online educational self-management program for adults who self-identified as women or female and had interstitial cystitis/bladder pain syndrome (IC/BPS). L2T combined self-paced online educational materials with a weekly live virtual group session. The primary feasibility objectives were recruitment, engagement, and retention. Exploratory outcomes included IC/BPS symptom and problem severity, pain intensity, pain-related interference and distress, and self-efficacy for chronic disease management. Qualitative data were collected to understand participants' experiences with the program.
详细描述
L2T used a flipped-classroom format over six weeks. Participants reviewed asynchronous e-learning materials each week and then attended a 60-90 minute live virtual group session facilitated by the research team to discuss and apply the lesson content. The program was informed by the THRIVE model, chronic pain science, adult learning, and instructional design principles. Quantitative assessments were conducted at baseline, immediately after the intervention, and 6 weeks after the intervention. Qualitative data were collected through open-ended survey questions, weekly lesson feedback, recordings of synchronous sessions, and post-intervention semi-structured interviews. This ClinicalTrials.gov record was entered retrospectively after study completion and was reconstructed from contemporaneous IRB-approved study materials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identifies as a woman or female
- •Age 18 years or older
- •Self-reported healthcare provider-confirmed diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS)
- •Pelvic pain, pressure, or discomfort for at least 6 months, of at least moderate severity (greater than 3 on a 0-10 numerical rating scale), causing weekly life interference and limiting life or work-related activities, general activity level, and/or enjoyment of life during the prior 3 months
- •Reliable access to a computer and Internet connection
排除标准
- •Unable to speak/read English
- •Neurological condition (for example, multiple sclerosis, Parkinson disease, paraplegia) or other condition affecting the bladder
- •History or presence of cystitis caused by tuberculosis, radiation, or chemotherapy
- •Diagnosed and treated for a pelvic-related malignancy (colon, bladder, ovarian, endometrial, uterine, cervical, vaginal, or rectal cancer)
- •Physical or psychological comorbidity that would adversely affect ability to participate
- •Currently pregnant
- •Gross cognitive impairment, deafness, blindness, or severe vision/hearing problems that could not be accommodated
- •Current psychotherapy directed specifically toward relief of urological symptoms
研究组 & 干预措施
Learning to THRIVE Program
Participants received the six-week Learning to THRIVE online educational self-management program.
干预措施: Learning to THRIVE (L2T) Program (Behavioral)
结局指标
主要结局
Number of Participants Enrolled During the Recruitment Period
时间窗: During the recruitment period, approximately 3 weeks
Number of participants who provided informed consent and enrolled during the planned recruitment period. The protocol planned to recruit 16 participants.
Participant-Reported Time Spent Reviewing Weekly Asynchronous Lessons
时间窗: Weekly during the 6-week intervention
Approximate time spent reviewing each weekly lesson, self-reported on the weekly lesson feedback form. Summarize using the metric used in the analysis (for example, median hours per week).
Number of Weekly Live Virtual Sessions Attended
时间窗: During the 6-week intervention
Facilitator-recorded attendance across the six weekly synchronous virtual meetings. Each participant could attend 0 to 6 sessions; a percentage of sessions attended may also be derived.
Number of Enrolled Participants Retained Through the Final Follow-Up Assessment
时间窗: From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks
Number and percentage of enrolled participants who remained in the study through the six-week post-intervention data-collection point. The protocol planned to recruit 16 participants and hoped to retain at least 12 through the intervention and post-intervention data-collection period.
次要结局
- Pain-Related Distress Severity Category(Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention)
- Interstitial Cystitis Symptom Index (ICSI) Score(Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention)
- Interstitial Cystitis Problem Index (ICPI) Score(Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention)
- Pain Intensity Severity Category(Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention)
- Pain Interference Severity Category(Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention)
- Self-Efficacy for Managing Chronic Disease (SEMCD) Score(Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention)
研究者
Elizabeth Moore
Principal Investigator
University of Indianapolis