Learning to THRIVE (L2T) Program Pilot (L2T)
27 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
15
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46227
- University of Indianapolis
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants Enrolled During the Recruitment Period
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Interstitial Cystitis Symptom Index (ICSI) Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participant Perceptions of Program Acceptability and Experience
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de agosto de 2023
Conclusão Primária (Real)
24 de dezembro de 2023
Conclusão do estudo (Real)
24 de dezembro de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
27 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de agosto de 2026
Primeira postagem (Real)
1 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Dor
- Manifestações Neurológicas
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças da Bexiga Urinária
- Cistite
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor crônica
- Cistite Intersticial
Outros números de identificação do estudo
- 01889
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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