- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03883594
Technology-Assisted Stepped Care Study (TASC Phase 3)
2022년 3월 9일 업데이트: Children's Hospital Medical Center, Cincinnati
Technology Assisted Stepped Care (TASC): Phase 3
The overall goal of this project is to demonstrate the feasibility, implementation, and preliminary efficacy of a technology-assisted stepped care (TASC) adherence-promotion intervention in adolescents with asthma.
This is the third phase (Phase 3) of a three-phase project to test the preliminary efficacy of a technology-assisted stepped care (TASC) intervention.
In Phase 1, we developed the intervention using patient and provider feedback from focus groups.
In Phase 2 we refined the developed intervention by having five adolescents from the focus groups test the intervention for feasibility.
In this third phase, we will enroll up to 50 adolescents to pilot-test the refined intervention for preliminary efficacy.
연구 개요
상세 설명
Up to fifty adolescents with asthma will be enrolled in an open label pilot trial of the TASC adherence-promotion intervention for a duration of twelve months.
First, participants will complete baseline questionnaires related to demographic, and clinical predictors of adherence and asthma and a 4 week run-in phase to assess baseline adherence using electronic inhaler monitoring with a cellphone that is provided to them.
Following the run-in period, all participants will receive Step 1 of the TASC intervention for a minimum of 4 weeks.
Step 1 (Information) will include electronic educational information related to asthma symptoms and triggers, attacks, self-monitoring, treatments, action plans, and automated text message medication reminders.
Following the initial four weeks of Step 1, adherence will be evaluated and a rate of less than 68% will serve as the cause for "stepping up" to the next level of the intervention.
Adherence checks will continue to occur every four weeks for the duration of the study and adherence <68% will prompt movement from one level of treatment to the next.
Participants may remain at a treatment level for more than four weeks and may complete 1, 2, or 3 interventions steps during the 5 month study depending on the adolescent's adherence.
Step 2 (Motivation) will include electronic monitoring of adherence and personally tailored feedback via text messages.
Adolescents will be given access to the adherence tracking cellphone app and graphs of their inhaler adherence.
Adolescents will also receive brief, personalized text messages that provide supportive motivation and directive, tangible actions.
Step 3 (Behavioral) will include problem-solving telehealth intervention with a trained clinician.
Four telehealth sessions individually tailored to the unique needs and barriers of the adolescent will be provided.
The primary outcome measure will be electronically-monitored adherence assessed at post-treatment.
Secondary outcomes include asthma severity as well as process evaluation questions and quantitative measures of feasibility, acceptability, and satisfaction to demonstrate implementation.
Participants will remain in the study for an additional 7 months after they complete month 5 of the study.
For the remaining 7 months, participants will be randomized to one of two booster session patterns with the goal to improve inhaler adherence.
The statistician will make the randomization schedule and the principle investigator will maintain the randomization schedule.
Two different booster patterns are being used to test which pattern will be most effective.
The first booster session pattern will include booster sessions at the end of month 6, 8, and 12.
The second booster session pattern will include booster sessions at the end of month 6, 7, 8, 10, and 12. Booster sessions will review content provided during the intervention and the intervention delivery method will be consistent with the participants final intervention step.
Participants will also continue to complete monthly check-ins with the study coordinator to complete the Composite Asthma Severity Index, the Asthma Control Test, and a spirometry test.
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45229
- Cincinnati Children's Medical Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patient age between 12-18 years
- Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
- Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator
- English fluency for patient, caregiver, and clinician
Exclusion Criteria:
- Significant cognitive deficits that may interfere with comprehension per medical team or chart review.
- Diagnosis of serious mental illness (e.g., schizophrenia)
- Diagnosis of pervasive developmental disorder
- Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis)
- Patient receives school administered daily controller medication at the time of the enrollment visit
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: TASC 개입
모든 참가자는 개입의 1단계를 받습니다.
순응도가 68% 미만이거나 68%인 참가자는 연구에서 3개월 또는 4개월 후에 2단계 또는 3단계로 올라갑니다.
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개입의 1단계에는 천식과 관련된 교육 자료가 포함됩니다.
2단계에는 준수에 대한 전자 모니터링과 참가자에게 개인적으로 맞춤화된 문자 메시지 개입이 포함됩니다.
3단계에는 숙련된 임상의와 함께 문제를 해결하는 원격 의료 세션이 포함됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Electronic Monitoring
기간: 12 months
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The Propeller Health monitoring system includes a Bluetooth enabled sensor that attaches to the patient's inhaler.
This sensor records every dose, or "puff", the patient takes and sends it to a corresponding online database that is accessible to study staff.
Participants will be given this sensor at baseline.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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타당성/수용성 설문지
기간: 5 개월
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형식, 내용, 길이, 기술 및 개입의 수용 가능성에 대한 5-31개 항목 측정이 각 단계의 끝과 연구가 끝날 때 설문지 형식으로 참가자에게 제공됩니다.
타당성 섹션은 0에서 4까지의 척도이며 0은 최악이고 4는 최고입니다.
수용성 설문지는 '전혀 그렇지 않다'에서 '매우 그렇다'까지 척도로 되어 있으며, '전혀 그렇지 않다'가 최악, '매우'가 최고입니다.
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5 개월
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시스템 사용성 척도
기간: 5 개월
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10개 항목, 유용성에 대한 전반적인 관점을 제공하는 리커트 척도는 각 단계의 끝과 연구가 끝날 때 설문지 형식으로 참가자에게 제공됩니다.
척도의 범위는 '전적으로 동의하지 않음'에서 '전적으로 동의함'까지이며 항목의 절반은 반대 점수를 받았습니다.
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5 개월
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Lung Function Assessment
기간: Baseline assessment and then once a month for 12 months
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The mobile spirometer records multiple parameters of the patient's lung function including forced expiratory volume, peak expiratory flow, forced vital capacity, and forced expiratory flow.
The spirometer sends the values to the corresponding mobile phone application, Propeller Health, which is directly accessible to the patient.
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Baseline assessment and then once a month for 12 months
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Composite Asthma Severity Index (CASI)
기간: Baseline assessment and then once a month for 12 months
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The participants' composite asthma severity index score will be calculated through the TreatSmart program.
TreatSmart will be used to determine the participant's symptom burden, health care utilization, systemic corticosteroid use, and current medication use to determine the level of asthma severity/control the participant has.
The program also makes an initial treatment recommendation based on the National Asthma Education and Prevention Program (NAEPP asthma guidelines).
Individuals are placed in Step 1 through Step 6 depending on the strength and frequency of their inhaled corticosteroid (1 being low dose and 6 being a high dose).
In addition, individuals are categorized as very poorly controlled, not well controlled, or well controlled based on how frequently they have had asthma symptoms or used their rescue inhaler, gone to the hospital or urgent care, or received steroids for asthma symptoms.
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Baseline assessment and then once a month for 12 months
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Asthma Control Test (ACT)
기간: Baseline assessment and then once a month for 12 months
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The ACT will be used as a measure of disease severity in this study.
The ACT is a 5-question scoring tool designed for patients with asthma who are 12 years and older.
The questions ask the patient to rate their asthma severity, symptom frequency, control, and inhaler use on a scale of 1-5.
The total score is calculated by the sum of each response, which determines how well-controlled the patient's asthma is on a scale from 5-25.
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Baseline assessment and then once a month for 12 months
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Attendance/Participation rates
기간: 12 months
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Participation rates will be measured 3 different ways.
The first measure will be how often participants accessed the electronic material (educational materials and/or Propeller Health app), the second measure will be how many responses to directive text messaging were received, and the third measure will be attendance to the telehealth sessions.
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12 months
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Acceptability of Intervention Measure (AIM)
기간: At 5 months
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A 4 item measure of participants' belief that the intervention is acceptable will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Intervention Appropriateness Measure (IAM)
기간: At 5 months
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A 4 item measure of participants' perception that the intervention is appropriate will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Feasibility of Intervention Measure (FIM)
기간: At 5 months
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A 4 item measure of participants' belief that the intervention is feasible will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Treatment Fidelity
기간: 12 months
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Treatment fidelity needed for the intervention will be assessed.
Treatment fidelity will be assessed through fidelity checklists created specifically for each intervention session.
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12 months
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Time Needed for Intervention
기간: 12 months
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Sessions will be timed and the number of weeks to complete the session will be tracked to determine the average length of time needed for the intervention.
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12 months
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Perceived Characteristics of Intervention Scale
기간: At 12 months
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19 item measure of interventionist views toward the study intervention.
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At 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Behavior Assessment System for Children-Third Edition, Self-report of Personality (BASC-3-SRP-A
기간: Baseline assessment and at 5 months
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The BASC-3 is a widely used, reliable (α= 0.94 - 0.96 , test-retest r= 0.81 -0.82), and valid inventory to assess emotional and behavioral symptoms in adolescents and young adults (ages 13-21).
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Baseline assessment and at 5 months
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Adolescent Barriers to Medication Scales (AMBS)
기간: Baseline Assessment
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The AMBS is an 18-item validated measure of perceived barriers to medication adherence in adolescents.
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Baseline Assessment
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Technology-based Experience of Need Satisfaction- Interface questionnaire (TENS-Interface)
기간: Baseline assessment and then at 2 months
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A 15- item measure of participant's competence, autonomy, and relatedness in using technology.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Autonomy and Competence in Technology Adoption Questionnaire (ACTA)
기간: Baseline Assessment
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A 10-item measure of why people adopt use of a technology (i.e.
download an app, register with a website, purchase a wearable device, etc.).Participants respond to self-regulation statements on a scale of 1 to 5, 1 being 'not at all true' and 5 being 'very true.'
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Baseline Assessment
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Technology-based Experience of Need Satisfaction- Task questionnaire (TENS- Task)
기간: Baseline assessment and then at 2 months
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An 8-item measure of participant's competence, autonomy, and relatedness in managing their asthma using technology.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Technology Effects on Need Satisfaction in Life (TENS- Life)
기간: Baseline assessment and then at 2 months
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The TENS-Life is a 10- item measure of the extent to which a user perceives that the use of a particular technology has had an influence on the satisfaction of basic psychological needs in their life.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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지식 설문지
기간: 기준 평가
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천식 증상, 유발 요인 및 약물에 대한 개인의 지식을 평가하는 13개 항목 설문지입니다.
참가자들은 각 진술에 대한 동의 수준을 '전적으로 동의함'에서 '전적으로 반대함'까지로 평가합니다.
이 설문지는 기본 방문 시 작성됩니다.
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기준 평가
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고난 설문지
기간: 기준 평가
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가구 내 개인의 재정적 부담을 평가하는 19개 항목으로 구성된 검증된 설문지입니다.
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기준 평가
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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)
2018년 12월 7일
기본 완료 (실제)
2021년 4월 20일
연구 완료 (실제)
2021년 4월 20일
연구 등록 날짜
최초 제출
2019년 2월 8일
QC 기준을 충족하는 최초 제출
2019년 3월 19일
처음 게시됨 (실제)
2019년 3월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 3월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 9일
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CIN001- {"TASC Phase 3"}
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
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. .