- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04579926
PINPOINT: Gaming Technology for SCD Pain (Pinpoint II)
29 lipca 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Rzeczywisty)
48
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Colorado
-
Golden, Colorado, Stany Zjednoczone, 80401
- Klein Buendel, Inc.
-
-
Indiana
-
Munster, Indiana, Stany Zjednoczone, 463213963
- Hilton Publishing Company
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
13 lat do 17 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Pinpoint App
Tablet and smartphone application.
|
Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Sickle Cell Disease (SCD) Knowledge Acquisition
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
PROMIS® (Patient-Reported Outcomes Measurement Information System)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
19 września 2018
Zakończenie podstawowe (Rzeczywisty)
30 czerwca 2022
Ukończenie studiów (Rzeczywisty)
30 czerwca 2022
Daty rejestracji na studia
Pierwszy przesłany
17 września 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 października 2020
Pierwszy wysłany (Rzeczywisty)
8 października 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 sierpnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 lipca 2022
Ostatnia weryfikacja
1 lipca 2021
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 322
- R44MD010746-02 (Grant/umowa NIH USA)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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Bambino Gesù Hospital and Research InstituteZakończonyCiężka otyłość dziecięca (BMI > 97° szt. -według wykresów BMI Centers for Disease Control and Prevention-) | Zmienione testy czynnościowe wątroby | Nietolerancja glikemicznaWłochy
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Spero TherapeuticsZakończonyKompleks Mycobacterium Avium | Niegruźlicze Mycobacterium Pulmonary DiseaseStany Zjednoczone
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Janssen Pharmaceutical K.K.RekrutacyjnyOporna na leczenie Mycobacterium Avium Complex-lung Disease (MAC-LD)Tajwan, Republika Korei, Japonia
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German CLL Study GroupRekrutacyjnyPBL | Białaczka, Prolimphocytic, T-Cell | SLL | Białaczka, Prolimphocytic, B-Cell | HCL | Białaczka T-LGL | Transformacja Richtera | Białaczka NK-LGLNiemcy
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