Learning to THRIVE (L2T) Program Pilot (L2T)
27. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
15
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Indiana
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Indianapolis, Indiana, Spojené státy, 46227
- University of Indianapolis
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants Enrolled During the Recruitment Period
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Interstitial Cystitis Symptom Index (ICSI) Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Participant Perceptions of Program Acceptability and Experience
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
29. srpna 2023
Primární dokončení (Aktuální)
24. prosince 2023
Dokončení studie (Aktuální)
24. prosince 2023
Termíny zápisu do studia
První předloženo
27. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
27. srpna 2026
První zveřejněno (Aktuální)
1. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Bolest
- Neurologické projevy
- Mužská urogenitální onemocnění
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Onemocnění močového měchýře
- Cystitida
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Chronická bolest
- Cystitida, intersticiální
Další identifikační čísla studie
- 01889
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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