Learning to THRIVE (L2T) Program Pilot (L2T)
2026년 8월 27일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
15
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46227
- University of Indianapolis
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Enrolled During the Recruitment Period
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Interstitial Cystitis Symptom Index (ICSI) Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participant Perceptions of Program Acceptability and Experience
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2023년 8월 29일
기본 완료 (실제)
기본 완료
2023년 12월 24일
연구 완료 (실제)
연구 완료
2023년 12월 24일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 27일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 27일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 1일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 27일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 01889
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .