Learning to THRIVE (L2T) Program Pilot (L2T)
27 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
15
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46227
- University of Indianapolis
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Learning to THRIVE Program
Participants received the six-week Learning to THRIVE online educational self-management program.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Enrolled During the Recruitment Period
Periodo de tiempo: During the recruitment period, approximately 3 weeks
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Number of participants who provided informed consent and enrolled during the planned recruitment period.
The protocol planned to recruit 16 participants.
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During the recruitment period, approximately 3 weeks
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Participant-Reported Time Spent Reviewing Weekly Asynchronous Lessons
Periodo de tiempo: Weekly during the 6-week intervention
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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).
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Weekly during the 6-week intervention
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Number of Weekly Live Virtual Sessions Attended
Periodo de tiempo: During the 6-week intervention
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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.
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During the 6-week intervention
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Number of Enrolled Participants Retained Through the Final Follow-Up Assessment
Periodo de tiempo: From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks
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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.
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From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Interstitial Cystitis Symptom Index (ICSI) Score
Periodo de tiempo: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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O'Leary-Sant ICSI total score, range 0-20; higher scores indicate greater urinary/pain symptom severity.
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Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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Interstitial Cystitis Problem Index (ICPI) Score
Periodo de tiempo: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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O'Leary-Sant ICPI total score, range 0-16; higher scores indicate greater symptom-related problems.
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Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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Pain Intensity Severity Category
Periodo de tiempo: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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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).
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Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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Pain Interference Severity Category
Periodo de tiempo: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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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).
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Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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Pain-Related Distress Severity Category
Periodo de tiempo: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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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).
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Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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Self-Efficacy for Managing Chronic Disease (SEMCD) Score
Periodo de tiempo: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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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.
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Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant Perceptions of Program Acceptability and Experience
Periodo de tiempo: 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
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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.
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de agosto de 2023
Finalización primaria (Actual)
24 de diciembre de 2023
Finalización del estudio (Actual)
24 de diciembre de 2023
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2026
Publicado por primera vez (Actual)
1 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Dolor
- Manifestaciones neurológicas
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades de la vejiga urinaria
- Cistitis
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor crónico
- Cistitis Intersticial
Otros números de identificación del estudio
- 01889
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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