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PINPOINT: Gaming Technology for SCD Pain (Pinpoint II)

29 juillet 2022 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

48

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Colorado
      • Golden, Colorado, États-Unis, 80401
        • Klein Buendel, Inc.
    • Indiana
      • Munster, Indiana, États-Unis, 463213963
        • Hilton Publishing Company

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

13 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Pinpoint App
Tablet and smartphone application.
Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sickle Cell Disease (SCD) Knowledge Acquisition
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PROMIS® (Patient-Reported Outcomes Measurement Information System)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 septembre 2018

Achèvement primaire (Réel)

30 juin 2022

Achèvement de l'étude (Réel)

30 juin 2022

Dates d'inscription aux études

Première soumission

17 septembre 2020

Première soumission répondant aux critères de contrôle qualité

1 octobre 2020

Première publication (Réel)

8 octobre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 août 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2022

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 322
  • R44MD010746-02 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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Essais cliniques sur Pinpoint app

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