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Learning to THRIVE (L2T) Program Pilot (L2T)

27 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

15

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46227
        • University of Indianapolis

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Learning to THRIVE Program
Participants received the six-week Learning to THRIVE online educational self-management program.
Behawioralne: 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.
Inne nazwy:
  • Learning to THRIVE
  • L2T

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Enrolled During the Recruitment Period
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Interstitial Cystitis Symptom Index (ICSI) Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Participant Perceptions of Program Acceptability and Experience
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Indianapolis

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 sierpnia 2023

Zakończenie podstawowe (Rzeczywisty)

24 grudnia 2023

Ukończenie studiów (Rzeczywisty)

24 grudnia 2023

Daty rejestracji na studia

Pierwszy przesłany

27 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

1 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 01889

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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