- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04579926
PINPOINT: Gaming Technology for SCD Pain (Pinpoint II)
2022년 7월 29일 업데이트: Klein Buendel, Inc.
PINPOINT: Gaming Technology to Engage Adolescent Sickle Cell Patients in Precision Pain Phase II
Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet programs to assist SCD adolescents with better identification and communication about pain are lacking.
Research shows that interactive gaming technology can enhance adolescents' learning, and can be especially effective in delivering health-related messages and tools to improve self-care.
Pinpoint is an interactive gaming app that will be tested in a Phase II project to determine whether the app assists SCD teens with improving their communication and identification skills for pain self-report.
연구 개요
상세 설명
Sickle cell disease (SCD) is the most common inherited blood disorder in the U.S. and disproportionately affects African Americans and Hispanics.
Approximately, 1,000 U.S. children are born with SCD annually.
SCD results from abnormal hemoglobin and causes red blood cells (RBCs) to become misshaped ("sickle-shaped").
Sickled cells can block the flow of blood in small arteries causing tissue and organ damage and other life-threatening comorbidities.
SCD complications can be serious and have a significant impact upon well-being and quality of life.
Pain is the hallmark symptom associated with SCD, and is the most common clinical problem seen in children and the number one cause of SCD-related hospital admissions.
If left untreated, these painful episodes can result in morbidity and mortality.
Accurate assessment of pain specifiers (type, frequency, and intensity of pain) can help with ameliorating pain quickly and effectively.
Despite children being accurate self-reporters of their pain, strategies which are effective and engaging to assist with pain identification and communication of pain are lacking.
In a Phase I SBIR, the investigator's team examined the feasibility and acceptability of a gamified tablet application (Pinpoint) intended to encourage teens to talk about and assess their SCD pain.
The Phase I specific aims were : (1) work with an Expert Advisory Board (EAB) of experts to develop a new pain assessment tool (PAT) to engage adolescent SCD patients, improve pain specification by patients, and improve pain management by clinicians; (2) conduct cognitive interviews and focus groups with 13-17 year old SCD patients to guide and refine development of app content, design, and aesthetics to fully develop a functioning prototype; (3) conduct usability testing with 13-17 year old SCD patients to assess functionality, navigation, and satisfaction; (4) conduct cognitive interviews with medical providers to provide input on app content, perceived barriers to use, and its potential for clinical use and integration to inform future implementation; and (5) develop a specifications document to outline the Phase II development plan.
Deliverables were met and feasibility was confirmed by the EAB.
The proposed Phase II project will (1) develop a fully programmed, interactive Pinpoint app consisting of modules to address pain identification and communication; (2) conduct usability testing of Pinpoint to evaluate the user interface, ease of use, and perceived barriers in order to optimize the app prior to large scale evaluation (n=14); and (3) test the full app with 13-17 year olds with SCD (n=100) using a randomized step wedge design to evaluate changes in (a) knowledge acquisition for communicating about pain and types of pain; (b) the Pain Assessment; (c) SCD general knowledge and self-efficacy; (d) family cohesion; and (e) app usage.
Overall, the proposed project has the potential to significantly impact the health of SCD teens by providing important skill acquisition for communicating about and identifying pain.
This project is innovative and timely.
Pinpoint will be the first app to identify and translate specific pain types for SCD into a gamified app using applied gamification principles.
연구 유형
중재적
등록 (실제)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Colorado
-
Golden, Colorado, 미국, 80401
- Klein Buendel, Inc.
-
-
Indiana
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Munster, Indiana, 미국, 463213963
- Hilton Publishing Company
-
-
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
13년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Be 13-17 years of age
- Be diagnosed with sickle cell disease
- Able to read and speak English
- Able to assent to participate
Exclusion Criteria:
- Not 13-17 years of age
- Not diagnosed with sickle cell disease
- Unable to read and speak English
- Unable to assent to participate
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)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Pinpoint App
Tablet and smartphone application.
|
Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Sickle Cell Disease (SCD) Knowledge Acquisition
기간: baseline
|
Communicating about pain & SCD pain knowledge: The primary outcome measure will be developed with an Expert Advisory Board (EAB).
Psychometric properties will be evaluated using a 3-step scale development process: (1)domain identification and item generation; (2)content expert validation, and (3)pilot test.
The investigative team will generate items using a sorting process that encompasses themes/construct elements noted in the communication and pain identification literature (Step 1).
Items will then be subjected to expert validation by the expert advisory board (Step 2), The Lawshe's Content Validity Ratio (CVR) will assess the content expert judgment; a minimum CVR value of 0.49 will be required for retention in the scale.
For Step 3, usability testers will be asked to complete the measure to guide initial psychometric evidence and allow for revision of the instrument prior to study launch.
Reporting of internal consistency reliability is a necessary part of scale development.
|
baseline
|
Sickle Cell Disease (SCD) Knowledge Acquisition
기간: 4-weeks
|
Communicating about pain and SCD pain knowledge: The primary outcome measure will be developed with the study's EAB.
Psychometric properties will be evaluated using a 3-step scale development process: (1) domain identification and item generation; (2) content expert validation, and (3) pilot test.
The investigative team will generate items using a sorting process that encompasses themes/construct elements noted in the communication and pain identification literature (Step 1).
Items will then be subjected to expert validation by the expert advisory board (Step 2), The Lawshe's Content Validity Ratio (CVR) will assess the content expert judgment; a minimum CVR value of 0.49 will be required for retention in the scale.
For Step 3, usability testers will be asked to complete the measure to guide initial psychometric evidence and allow for revision of the instrument prior to study launch.
Reporting of internal consistency reliability is a necessary part of scale development.
|
4-weeks
|
Sickle Cell Disease (SCD) Knowledge Acquisition
기간: 8-weeks
|
Communicating about pain & SCD pain knowledge: The primary outcome measure will be developed with the study's EAB.
Psychometric properties will be evaluated using a 3-step scale development process: (1)domain identification and item generation; (2)content expert validation, and (3)pilot test.
The investigative team will generate items using a sorting process that encompasses themes/construct elements noted in the communication and pain identification literature (Step 1).
Items will then be subjected to expert validation by the expert advisory board (Step 2), The Lawshe's Content Validity Ratio (CVR) will assess the content expert judgment; a minimum CVR value of 0.49 will be required for retention in the scale.
For Step 3, usability testers will be asked to complete the measure to guide initial psychometric evidence and allow for revision of the instrument prior to study launch.
Reporting of internal consistency reliability is a necessary part of scale development.
|
8-weeks
|
Sickle Cell Disease (SCD) Knowledge Acquisition
기간: 12-weeks
|
Communicating about pain & SCD pain knowledge: The primary outcome measure will be developed with the study's EAB.
Psychometric properties will be evaluated using a 3-step scale development process: (1) domain identification and item generation; (2) content expert validation, and (3) pilot test.
The investigative team will generate items using a sorting process that encompasses themes/construct elements noted in the communication and pain identification literature (Step 1).
Items will then be subjected to expert validation by the expert advisory board (Step 2), The Lawshe's Content Validity Ratio (CVR) will assess the content expert judgment; a minimum CVR value of 0.49 will be required for retention in the scale.
For Step 3, usability testers will be asked to complete the measure to guide initial psychometric evidence and allow for revision of the instrument prior to study launch.
Reporting of internal consistency reliability is a necessary part of scale developmen
|
12-weeks
|
Sickle Cell Disease (SCD) Knowledge Acquisition
기간: 16-weeks
|
Communicating about pain & SCD pain knowledge: The primary outcome measure will be developed with the study's EAB.
Psychometric properties will be evaluated using a 3-step scale development process: (1)domain identification and item generation; (2)content expert validation, and (3)pilot test.
The investigative team will generate items using a sorting process that encompasses themes/construct elements noted in the communication and pain identification literature (Step 1).
Items will then be subjected to expert validation by the expert advisory board (Step 2), The Lawshe's Content Validity Ratio (CVR) will assess the content expert judgment; a minimum CVR value of 0.49 will be required for retention in the scale.
For Step 3, usability testers will be asked to complete the measure to guide initial psychometric evidence and allow for revision of the instrument prior to study launch.
Reporting of internal consistency reliability is a necessary part of scale development.
|
16-weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
PROMIS® (Patient-Reported Outcomes Measurement Information System)
기간: baseline
|
subset of PROMIS measures: The PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of self-report measures that evaluates physical, mental, and social health in adults and children living with or without chronic conditions.
The following PROMIS measures will be administered: Family Relationships, Physical Activity, Physical Stress Experiences, Strength Impact, Pain Behavior, Pain Quality- Sensory, Pain Quality-Affective Pain Interference, Psychological Stress Experiences, and Peer Relationships domains.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
High scores mean more of the concept being measured.
On the T-score metric: A score of 40 is one SD lower than the mean of the reference population.
A score of 60 is one SD higher than the mean of the reference population.
This could be a desirable or undesirable outcome, depending upon the concept
|
baseline
|
PROMIS® (Patient-Reported Outcomes Measurement Information System)
기간: 4-weeks
|
subset of PROMIS measures: The PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of self-report measures that evaluates physical, mental, and social health in adults and children living with or without chronic conditions.
The following PROMIS measures will be administered: Family Relationships, Physical Activity, Physical Stress Experiences, Strength Impact, Pain Behavior, Pain Quality- Sensory, Pain Quality-Affective Pain Interference, Psychological Stress Experiences, and Peer Relationships domains.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
High scores mean more of the concept being measured.
On the T-score metric: A score of 40 is one SD lower than the mean of the reference population.
A score of 60 is one SD higher than the mean of the reference population.
This could be a desirable or undesirable outcome, depending upon the concept
|
4-weeks
|
PROMIS® (Patient-Reported Outcomes Measurement Information System)
기간: 8-weeks
|
subset of PROMIS measures: The PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of self-report measures that evaluates physical, mental, and social health in adults and children living with or without chronic conditions.
The following PROMIS measures will be administered: Family Relationships, Physical Activity, Physical Stress Experiences, Strength Impact, Pain Behavior, Pain Quality- Sensory, Pain Quality-Affective Pain Interference, Psychological Stress Experiences, and Peer Relationships domains.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
High scores mean more of the concept being measured.
On the T-score metric: A score of 40 is one SD lower than the mean of the reference population.
A score of 60 is one SD higher than the mean of the reference population.
This could be a desirable or undesirable outcome, depending upon the concept
|
8-weeks
|
PROMIS® (Patient-Reported Outcomes Measurement Information System)
기간: 12-weeks
|
subset of PROMIS measures: The PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of self-report measures that evaluates physical, mental, and social health in adults and children living with or without chronic conditions.
The following PROMIS measures will be administered: Family Relationships, Physical Activity, Physical Stress Experiences, Strength Impact, Pain Behavior, Pain Quality- Sensory, Pain Quality-Affective Pain Interference, Psychological Stress Experiences, and Peer Relationships domains.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
High scores mean more of the concept being measured.
On the T-score metric: A score of 40 is one SD lower than the mean of the reference population.
A score of 60 is one SD higher than the mean of the reference population.
This could be a desirable or undesirable outcome, depending upon the concept
|
12-weeks
|
PROMIS® (Patient-Reported Outcomes Measurement Information System)
기간: 16-weeks
|
subset of PROMIS measures: The PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of self-report measures that evaluates physical, mental, and social health in adults and children living with or without chronic conditions.
The following PROMIS measures will be administered: Family Relationships, Physical Activity, Physical Stress Experiences, Strength Impact, Pain Behavior, Pain Quality- Sensory, Pain Quality-Affective Pain Interference, Psychological Stress Experiences, and Peer Relationships domains.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
High scores mean more of the concept being measured.
On the T-score metric: A score of 40 is one SD lower than the mean of the reference population.
A score of 60 is one SD higher than the mean of the reference population.
This could be a desirable or undesirable outcome, depending upon the concept
|
16-weeks
|
SCD Knowledge Quiz
기간: baseline
|
SCD knowledge: The SCD Knowledge Quiz is a reliable 10-item measure developed from the Stepping Up to Adult Care Program.
Content areas covered are SCD etiology, clinical manifestations, and medical management.
Total scores are calculated by summing all items.
Higher scores indicate better knowledge of SCD and its treatment.
|
baseline
|
SCD Knowledge Quiz
기간: 4-weeks
|
SCD knowledge: The SCD Knowledge Quiz is a reliable 10-item measure developed from the Stepping Up to Adult Care Program.
Content areas covered are SCD etiology, clinical manifestations, and medical management.
Total scores are calculated by summing all items.
Higher scores indicate better knowledge of SCD and its treatment.
|
4-weeks
|
SCD Knowledge Quiz
기간: 8-weeks
|
SCD knowledge: The SCD Knowledge Quiz is a reliable 10-item measure developed from the Stepping Up to Adult Care Program.
Content areas covered are SCD etiology, clinical manifestations, and medical management.
Total scores are calculated by summing all items.
Higher scores indicate better knowledge of SCD and its treatment.
|
8-weeks
|
SCD Knowledge Quiz
기간: 12-weeks
|
SCD knowledge: The SCD Knowledge Quiz is a reliable 10-item measure developed from the Stepping Up to Adult Care Program.
Content areas covered are SCD etiology, clinical manifestations, and medical management.
Total scores are calculated by summing all items.
Higher scores indicate better knowledge of SCD and its treatment.
|
12-weeks
|
SCD Knowledge Quiz
기간: 16-weeks
|
SCD knowledge: The SCD Knowledge Quiz is a reliable 10-item measure developed from the Stepping Up to Adult Care Program.
Content areas covered are SCD etiology, clinical manifestations, and medical management.
Total scores are calculated by summing all items.
Higher scores indicate better knowledge of SCD and its treatment.
|
16-weeks
|
SCD Transition Knowledge Questionnaire
기간: baseline
|
SCD knowledge: The SCD Transition Knowledge Questionnaire is a 25-item measure that assesses SCD knowledge relevant to preparation for transition to adult services.
It is designed to assess knowledge in 7 areas: (1) pathophysiology, (2) genetics, (3) physical symptoms, (4) treatment, (5) self-care, (6) psychosocial and developmental issues, and (7) health care delivery.
Higher scores indicate better knowledge of SCD and its treatment.
|
baseline
|
SCD Transition Knowledge Questionnaire
기간: 4-weeks
|
SCD knowledge: The SCD Transition Knowledge Questionnaire is a 25-item measure that assesses SCD knowledge relevant to preparation for transition to adult services.
It is designed to assess knowledge in 7 areas: (1) pathophysiology, (2) genetics, (3) physical symptoms, (4) treatment, (5) self-care, (6) psychosocial and developmental issues, and (7) health care delivery.
Higher scores indicate better knowledge of SCD and its treatment.
|
4-weeks
|
SCD Transition Knowledge Questionnaire
기간: 8-weeks
|
SCD knowledge: The SCD Transition Knowledge Questionnaire is a 25-item measure that assesses SCD knowledge relevant to preparation for transition to adult services.
It is designed to assess knowledge in 7 areas: (1) pathophysiology, (2) genetics, (3) physical symptoms, (4) treatment, (5) self-care, (6) psychosocial and developmental issues, and (7) health care delivery.
Higher scores indicate better knowledge of SCD and its treatment.
|
8-weeks
|
SCD Transition Knowledge Questionnaire
기간: 12-weeks
|
SCD knowledge: The SCD Transition Knowledge Questionnaire is a 25-item measure that assesses SCD knowledge relevant to preparation for transition to adult services.
It is designed to assess knowledge in 7 areas: (1) pathophysiology, (2) genetics, (3) physical symptoms, (4) treatment, (5) self-care, (6) psychosocial and developmental issues, and (7) health care delivery.
Higher scores indicate better knowledge of SCD and its treatment.
|
12-weeks
|
SCD Transition Knowledge Questionnaire
기간: 16-weeks
|
SCD knowledge: The SCD Transition Knowledge Questionnaire is a 25-item measure that assesses SCD knowledge relevant to preparation for transition to adult services.
It is designed to assess knowledge in 7 areas: (1) pathophysiology, (2) genetics, (3) physical symptoms, (4) treatment, (5) self-care, (6) psychosocial and developmental issues, and (7) health care delivery.
Higher scores indicate better knowledge of SCD and its treatment.
|
16-weeks
|
Sickle Cell Self-efficacy Scale
기간: baseline
|
SCD self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain).
The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD.
Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy.
|
baseline
|
Sickle Cell Self-efficacy Scale
기간: 4-weeks
|
SCD self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain).
The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD.
Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy.
|
4-weeks
|
Sickle Cell Self-efficacy Scale
기간: 8-weeks
|
SCD self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain).
The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD.
Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy.
|
8-weeks
|
Sickle Cell Self-efficacy Scale
기간: 12-weeks
|
SCD self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain).
The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD.
Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy.
|
12-weeks
|
Sickle Cell Self-efficacy Scale
기간: 16-weeks
|
SCD self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain).
The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD.
Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy.
|
16-weeks
|
Adolescent Patient-Provider Interaction Scale
기간: baseline
|
Adolescent patient-provider communication: This 9-item instrument is designed to assess adolescent patient-provider communication and empowerment.
Total scores are obtained by summing the Likert-item responses for each question.
One item is reverse coded.
Higher scores represent better interactions.
|
baseline
|
Adolescent Patient-Provider Interaction Scale
기간: 4-weeks
|
Adolescent patient-provider communication: This 9-item instrument is designed to assess adolescent patient-provider communication and empowerment.
Total scores are obtained by summing the Likert-item responses for each question.
One item is reverse coded.
Higher scores represent better interactions.
|
4-weeks
|
Adolescent Patient-Provider Interaction Scale
기간: 8-weeks
|
Adolescent patient-provider communication: This 9-item instrument is designed to assess adolescent patient-provider communication and empowerment.
Total scores are obtained by summing the Likert-item responses for each question.
One item is reverse coded.
Higher scores represent better interactions.
|
8-weeks
|
Adolescent Patient-Provider Interaction Scale
기간: 12-weeks
|
Adolescent patient-provider communication: This 9-item instrument is designed to assess adolescent patient-provider communication and empowerment.
Total scores are obtained by summing the Likert-item responses for each question.
One item is reverse coded.
Higher scores represent better interactions.
|
12-weeks
|
Adolescent Patient-Provider Interaction Scale
기간: 16-weeks
|
Adolescent patient-provider communication: This 9-item instrument is designed to assess adolescent patient-provider communication and empowerment.
Total scores are obtained by summing the Likert-item responses for each question.
One item is reverse coded.
Higher scores represent better interactions.
|
16-weeks
|
Family Cohesion scale from the Child Health Questionnaire (CHQ)
기간: baseline
|
Family communication: Family cohesion will be assessed by the single item Family Cohesion scale ("In general, how would you rate your family's ability to get along with one another?")
from the Child Health Questionnaire (CHQ), a pediatric QOL survey that has been normed for children age 5-18 years including those with chronic diseases.
The option response is on a 5-point Likert scale.
Th score is transformed to a 0 -100 scale, with a mean of 50 and standard deviation of 10.
Higher scores better functioning.
|
baseline
|
Family Cohesion scale from the Child Health Questionnaire (CHQ)
기간: 4-weeks
|
Family communication: Family cohesion will be assessed by the single item Family Cohesion scale ("In general, how would you rate your family's ability to get along with one another?")
from the Child Health Questionnaire (CHQ), a pediatric QOL survey that has been normed for children age 5-18 years including those with chronic diseases.
The option response is on a 5-point Likert scale.
Th score is transformed to a 0 -100 scale, with a mean of 50 and standard deviation of 10.
Higher scores better functioning.
|
4-weeks
|
Family Cohesion scale from the Child Health Questionnaire (CHQ)
기간: 8-weeks
|
Family communication: Family cohesion will be assessed by the single item Family Cohesion scale ("In general, how would you rate your family's ability to get along with one another?")
from the Child Health Questionnaire (CHQ), a pediatric QOL survey that has been normed for children age 5-18 years including those with chronic diseases.
The option response is on a 5-point Likert scale.
Th score is transformed to a 0 -100 scale, with a mean of 50 and standard deviation of 10.
Higher scores better functioning.
|
8-weeks
|
Family Cohesion scale from the Child Health Questionnaire (CHQ)
기간: 12-weeks
|
Family communication: Family cohesion will be assessed by the single item Family Cohesion scale ("In general, how would you rate your family's ability to get along with one another?")
from the Child Health Questionnaire (CHQ), a pediatric QOL survey that has been normed for children age 5-18 years including those with chronic diseases.
The option response is on a 5-point Likert scale.
Th score is transformed to a 0 -100 scale, with a mean of 50 and standard deviation of 10.
Higher scores better functioning.
|
12-weeks
|
Family Cohesion scale from the Child Health Questionnaire (CHQ)
기간: 16-weeks
|
Family communication: Family cohesion will be assessed by the single item Family Cohesion scale ("In general, how would you rate your family's ability to get along with one another?")
from the Child Health Questionnaire (CHQ), a pediatric QOL survey that has been normed for children age 5-18 years including those with chronic diseases.
The option response is on a 5-point Likert scale.
Th score is transformed to a 0 -100 scale, with a mean of 50 and standard deviation of 10.
Higher scores better functioning.
|
16-weeks
|
System Usability Scale (SUS)
기간: 16-weeks
|
Technology acceptability: The System Usability Scale (SUS) is a reliable tool for measuring the usability of technologies.
It consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100.
Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.
|
16-weeks
|
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 9월 19일
기본 완료 (실제)
2022년 6월 30일
연구 완료 (실제)
2022년 6월 30일
연구 등록 날짜
최초 제출
2020년 9월 17일
QC 기준을 충족하는 최초 제출
2020년 10월 1일
처음 게시됨 (실제)
2020년 10월 8일
연구 기록 업데이트
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2022년 8월 2일
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2022년 7월 29일
마지막으로 확인됨
2021년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 322
- R44MD010746-02 (미국 NIH 보조금/계약)
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. .
겸상 적혈구 질환에 대한 임상 시험
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Sandy SrinivasGlaxoSmithKline완전한방광암 | 방광(요로상피, 이행세포) 암 | 방광(Urothelial, Transitional Cell) 절제 가능한 암(방광절제술 전) | 방광(Urothelial, Transitional Cell) 암 표재성(비침습성) | 방광(Urothelial, Transitional Cell) 암 전이성 또는 절제 불가능미국
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Stanford UniversityNational Institutes of Health (NIH)빼는방광암 | 피부암 | 방광(요로상피, 이행세포) 암 | 방광(Urothelial, Transitional Cell) 절제 가능한 암(방광절제술 전)미국
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
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SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.모병미만성 거대 B세포 림프종 | 재발성 미만성 대형 B세포 림프종 | 난치성 미만성 대형 B세포 림프종 | 원발성 종격동(흉선) 대형 B세포 림프종 | 등급 3b 여포성 림프종 | 변형된 여포 림프를 Diff 대형 B-세포 림프종으로 | 변형된 마그 존 림프를 Diff Large B-Cell Lymphoma로미국
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University of Alabama at Birmingham종료됨역형성 대세포 림프종 | 혈관면역모세포성 T세포 림프종 | 말초 T 세포 림프종 | 성인 T 세포 백혈병 | 성인 T 세포 림프종 | 상세불명의 말초 T 세포 림프종 | T/Null Cell 전신형 | 림프절/내장 질환을 동반한 피부 T세포 림프종미국
Pinpoint app에 대한 임상 시험
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Leiden University Medical CenterMedical Center Haaglanden; Groene Hart Ziekenhuis; Reinier de Graaf Groep; Alrijne Ziekenhuis... 그리고 다른 협력자들모병
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Chang Gung University of Science and TechnologyChang Gung Memorial Hospital; Ministry of Science and Technology, Taiwan모병
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical...완전한
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Kaohsiung Medical University Chung-Ho Memorial...완전한
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University of FloridaSociety of University Surgeons완전한