- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04579926
PINPOINT: Gaming Technology for SCD Pain (Pinpoint II)
29. července 2022 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
48
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Colorado
-
Golden, Colorado, Spojené státy, 80401
- Klein Buendel, Inc.
-
-
Indiana
-
Munster, Indiana, Spojené státy, 463213963
- Hilton Publishing Company
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
13 let až 17 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Pinpoint App
Tablet and smartphone application.
|
Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Sickle Cell Disease (SCD) Knowledge Acquisition
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
PROMIS® (Patient-Reported Outcomes Measurement Information System)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
19. září 2018
Primární dokončení (Aktuální)
30. června 2022
Dokončení studie (Aktuální)
30. června 2022
Termíny zápisu do studia
První předloženo
17. září 2020
První předloženo, které splnilo kritéria kontroly kvality
1. října 2020
První zveřejněno (Aktuální)
8. října 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. srpna 2022
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. července 2022
Naposledy ověřeno
1. července 2021
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 322
- R44MD010746-02 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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