Learning to THRIVE (L2T) Program Pilot (L2T)
27. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
15
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Indiana
-
Indianapolis, Indiana, Vereinigte Staaten, 46227
- University of Indianapolis
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Learning to THRIVE Program
Participants received the six-week Learning to THRIVE online educational self-management 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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Enrolled During the Recruitment Period
Zeitfenster: 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
Zeitfenster: 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
|
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Number of Weekly Live Virtual Sessions Attended
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Interstitial Cystitis Symptom Index (ICSI) Score
Zeitfenster: 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
Zeitfenster: 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.
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Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
|
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Pain Intensity Severity Category
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Participant Perceptions of Program Acceptability and Experience
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
29. August 2023
Primärer Abschluss (Tatsächlich)
24. Dezember 2023
Studienabschluss (Tatsächlich)
24. Dezember 2023
Studienanmeldedaten
Zuerst eingereicht
27. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. August 2026
Zuerst gepostet (Tatsächlich)
1. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Schmerzen
- Neurologische Manifestationen
- Männliche Urogenitalerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Erkrankungen der Harnblase
- Zystitis
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Chronischer Schmerz
- Zystitis, interstitielle
Andere Studien-ID-Nummern
- 01889
Plan für individuelle Teilnehmerdaten (IPD)
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UNENTSCHIEDEN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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