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Learning to THRIVE (L2T) Program Pilot (L2T)

27 августа 2026 г. обновлено: Elizabeth Moore, University of Indianapolis
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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

15

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Learning to THRIVE Program
Participants received the six-week Learning to THRIVE online educational self-management program.
Поведенческий: Learning to THRIVE (L2T) Program
A six-week online self-management program using a flipped-classroom format. Each week, participants reviewed asynchronous e-learning materials and attended one 60-90 minute live virtual group meeting facilitated by the research team. Content addressed goal setting and safe-group expectations; chronic pain and factors influencing pain; self-care, habits, and self-efficacy; relationships, communication, and sexual health; informed healthcare decision-making and evaluation of health claims; and reflection with long-term action planning.
Другие имена:
  • Learning to THRIVE
  • L2T

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants Enrolled During the Recruitment Period
Временное ограничение: 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.
During the recruitment period, approximately 3 weeks
Participant-Reported Time Spent Reviewing Weekly Asynchronous Lessons
Временное ограничение: 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).
Weekly during the 6-week intervention
Number of Weekly Live Virtual Sessions Attended
Временное ограничение: 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.
During the 6-week intervention
Number of Enrolled Participants Retained Through the Final Follow-Up Assessment
Временное ограничение: 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.
From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Interstitial Cystitis Symptom Index (ICSI) Score
Временное ограничение: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
O'Leary-Sant ICSI total score, range 0-20; higher scores indicate greater urinary/pain symptom severity.
Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Interstitial Cystitis Problem Index (ICPI) Score
Временное ограничение: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
O'Leary-Sant ICPI total score, range 0-16; higher scores indicate greater symptom-related problems.
Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain Intensity Severity Category
Временное ограничение: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain intensity during the prior week assessed on an 11-point numerical rating scale from 0 to 10 and categorized according to the protocol as none (0), mild (1-3), moderate (4-6), or severe (7-10).
Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain Interference Severity Category
Временное ограничение: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain-related interference with activities during the prior week assessed on an 11-point numerical rating scale from 0 to 10 and categorized as none (0), mild (1-3), moderate (4-6), or severe (7-10).
Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain-Related Distress Severity Category
Временное ограничение: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain-related distress during the prior week assessed on an 11-point numerical rating scale from 0 to 10 and categorized as none (0), mild (1-3), moderate (4-6), or severe (7-10).
Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Self-Efficacy for Managing Chronic Disease (SEMCD) Score
Временное ограничение: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Six-item SEMCD scale scored from 1 to 10, with higher scores indicating greater confidence in managing chronic disease. The protocol included SEMCD as a quantitative outcome at all three assessments.
Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Participant Perceptions of Program Acceptability and Experience
Временное ограничение: Weekly during the 6-week intervention and within 1 month after intervention completion; open-ended survey data also collected at baseline, immediately post-intervention, and 6 weeks post-intervention
Qualitative data were collected through open-ended questions on the study surveys, weekly lesson feedback, recorded live group discussions, and semi-structured post-intervention interviews. Weekly feedback addressed key takeaways, useful content, areas needing greater clarity, and additional comments. Interviews explored expectations, program structure, content usefulness, facilitator/peer interaction, safety and comfort, application of learning, and whether participants would recommend the program. Data were prospectively planned for thematic analysis.
Weekly during the 6-week intervention and within 1 month after intervention completion; open-ended survey data also collected at baseline, immediately post-intervention, and 6 weeks post-intervention

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Indianapolis

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

29 августа 2023 г.

Первичное завершение (Действительный)

24 декабря 2023 г.

Завершение исследования (Действительный)

24 декабря 2023 г.

Даты регистрации исследования

Первый отправленный

27 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

27 августа 2026 г.

Первый опубликованный (Действительный)

1 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 01889

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Описание плана IPD

The informed consent permits possible future research use or sharing of de-identified study data, but a specific individual participant data sharing plan, access mechanism, and timetable have not yet been established.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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