Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443073
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-15
Brief Title:
The Mere-measurement Effect of Patient-reported Outcomes
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
The Mere-measurement Effect in Patient-reported Outcomes A Randomized Control Trial With Speech Pathology Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of patient-reported outcome PROs have become increasingly commonplace across many healthcare settings over the past two decades The value of PROs is now acknowledged by healthcare providers and patients alike However to date little is known about the best practices for formulating PRO measures PROMS but even more specifically the effect had on the responding patients as a result of item word choice emotional valence or frequency of use That is 1 does the positive or negative wording of items affect the patients perspective on the latent variable 2 is there a degree of subliminal influence or measurement effects on their behaviour resulting from exposure to PROs and finally 3 is such an effect amplified with repeated exposure
Detailed Description:
There is currently sufficient evidence to suggest that attributes such as the wording of questions their presentation order the context where they are asked and the items social sensitivity eg I do not abuse my prescriptions have an effect on participant responses 12 This family of variables are most oft referred to as method effects Method effects largely regard the phenomenon in which the presentation of an item affects the participants response independent of the content in question The end goal within this area of study is to correct for any response bias resulting from the items used This research primarily concerns psychometrics It is important to note that while method effects relate to the research questions proposed it is not the key feature of interest The ensuing inquiry will not simply focus directly on changes to item responses but instead on changes to patient perceptions and behaviours as a result of their exposure to the measures themselves This has been coined the mere-measurement effect 3 Research supports the claim that asking certain questions can influence behaviours on the same topic 45 For example a randomized-control trial was conducted to assess the impact of asking questions pertaining to blood donation habits of the participants The researchers found that the subjects whom were asked about their habits were significantly more likely to donate blood than their control counter parts at the following blood-drive 6 Other researchers found that when clinicians did not ask patients with Attention Deficit Hyperactivity Disorder ADHD to report whether they were currently medicated on a disease-related severity questionnaire patients were more likely to report un-medicated symptomologies 7 In other words patients on ADHD medications responded more symptomatically similar to their un-medicated selves when their medication status was not included on the questionnaire This suggests that the medication status item itself may have mitigated ADHD symptoms by bringing the patients treatment into a higher state of awarenessdirecting attention
Thus it may be that asking patients about their intent to have an operation increases the likelihood of them opting for it or that asking them about their exercise increases their physical activity level If so this may have significant implications for the effect of routinely collecting patient-reported outcomes PROs as well as for utilizing measurements as interventions However before value can be attached to such an effect first the presence and strength must be evaluated in the patient-specific context
To date no mere-measurement effect factors have been investigated in the context of patient-reported outcomes measures PROMs and particularly not in regard to how they may influence patient perceptions and behaviours Therefore exploration of this family of effects must be reduced to a few key anticipated features namely emotional valence positivenegative and frequency For instance would wording a cleft-lip question negatively such as I do not like my face actually decrease the patients preference for their own face and does repeated exposure to this question increase the magnitude of the effect
This randomized controlled trial RCT review will be the first to the authors knowledge to examine if measuring patient- reported outcomes directly effects their corresponding behaviour and if this effect can be attributed in part to item wording andor frequency of exposure
PROMs Speech Disorders Three recent reviews regarding patient-reported outcomes in speech pathologies were identified 8910 Francis et al list a number of PRO measures that were designed for administration with subjects with any kind of voice disorders The Evaluating Voice Disability-Quality of Life Questionaire EVD-QOL aims at assessing the general range of functional problems in voice disorders The 30-items Voice Handicap Index VHI and its 10-items short version VHI-10 aim at providing a psychometrically robust voice diasabilityhandicap inventory The Voice-Related Quality of Life V-RQOL aims at measuring the impact of voice problems on the quality of life The Voice Activity and Participation Profile VAPP aims at identifying voice activity limitation and participation restriction separately The Voice Symptom Scale VoiSS is an inventory of voice symptoms for assessing baseline pathology and response to change The Communicative Participation Item Bank CPIB aims at assessing communication participation in all kinds of communication disorders The Voice Self-Efficacy Questionnaire VSEQ monitors self-efficacy in individuals with self-declared voice problems before and after interventions The Vocal Fatigue Handicap Questionnaire VFHQ and the Vocal Fatigue Index VFI aim at reflecting vocal fatigue
Additional PROs include the Aging Voice Index the Evaluation of the Ability to Sing Easily the Glottal Function Index the Linear Analog Scale of Assessment of Voice Quality the Speech Disability Questionnaire the Trans Woman Voice Questionnaire the Vocal Cord Dysfunction Questionnaire and the Vocal Tract Discomfort Scale Slavych Zraick Ruleman 2021
The researchers have opted to use the CPIB and the VHI because these are well established and the former covers all kinds of communication disorders while the VHI is using particularly negative wording in its original form
12 STUDY RATIONALE The purpose of the mere-measurement study is to identify the most advantageous way to measure outcomes for patients This will be accomplished by collecting measures on the same topic at different time intervals and with different wording of questions The findings of this study should help researchers and clinicians collect measurements from patients in the least burdensome and most beneficial manner possible
The primary objective of the mere-measurement study is to assess the effects of different collection methods on the responders wellbeing
The secondary objectives of this study are to
What frequency of collection is best for patients
What style of question wording is best for patients
Research Questions
Does the assigned positivity or negativity of an item effect patient perception or behaviour on the topic inquired
Does frequency of exposure to an item have an effect on patient perception or behaviour of the topic inquired
Hypotheses
H1 The more a patient reads and responds to questions about their speech condition the more their speech condition will be affected
H2 The directionality of impact on a speech condition will be congruent with the emotional valence of the items used
STUDY DESIGN Once a subject has agreed to participate in this study they will be asked to complete online questionnaires as well as record their voice reading a collection of random words 2-4 times
This study follows a 2x2 design Participants will be randomly assigned to one of four groups Randomization will be accomplished by using the MUW randomizer Participants will be stratified by education and speech disorder type The healthy case control group will undergo case matching to ensure comparability across groups Each group will receive two brief speech pathology severity questionnaires but at different frequencies and with slight adjustments to the wording Depending on the experimental group a subject will complete the questionnaires either two or four times separated each time by one week The questionnaires in all groups will take approximately 15 minutes to complete Lastly at the very start and once at the very end of the study every participant will also be asked to record a brief 45 second audio file in the online survey as well as complete two additional psychological questionnaires
The measures in this study cover the following tools complete measures are uploaded in the ECS
A patient-reported outcome on voice health - Voice Handicap Index VHI or Voice Handicap Index Positively adapted VHI-PA
A patient-reported outcome on speech health - Communicative Participation Item Bank CPIB or Communicative Participation Item Bank Positively adapted CPIB-PA
A self-esteem stability scale - Self-Esteem Stability Scale SESS
A self-esteem scale - Rosenberg Self-Esteem Scale RSS
Two question measure of disease impact 2DB
A single-question measure of disease activity 1DS
Audio recording of text read aloud ARec
Study population All patients with Muscle tension dysphonia Inducible laryngeal obstruction Amyotrophic lateral sclerosis ALS suffering from a stroke or other brain injurydamagetrauma aphasia dysarthria and Parkinsons disease will be targeted for recruitment There are no geographic location requirements The participation schedule can be found below Patients will be informed of the schedule in advance A subject must complete any respective sampling epoch within 48 hours of the prescribed date in order to qualify as completed Subjects must also have strong English skills and be technologically savvy to participate Only adults will be included in the study
Study Design Flow Group 1 High frequency-negative 1 week between each collection
1 Demographics VHI CPIB SESS RSS 1DS 1DB ARec
2 VHI CPIB SE SSE 1DS 2DB ARec
3 VHI CPIB SE SSE 1DS 2DB ARec
4 VHI CPIB SE SSE 1DS 2DB ARec Group 2 High frequency-positive 1 week between each collection
-- --
1 Demographics VHI-PA CPIB-PA SESS RSS 1DS 2DB ARec
2 VHI-PA CPIB-PA SE SSE 1DS 2DB ARec
3 VHI-PA CPIB-PA SE SSE 1DS 2DB ARec
4 VHI-PA CPIB-PA SE SSE 1DS 2DB ARec Group 3 Low frequency-negative 2 weeks between each collection
1 Demographics VHI CPIB SESS RSS 1DS 2DB ARec 2 VHI CPIB SE SSE 1DS 2DB ARec Group 4 Low frequency-positive 2 weeks between each collection
1 Demographics VHI-PA CPIB-PA SESS RSS 1DS 2DB 1ARec
2 VHI-PA CPIB-PA SE SSE 1DS 2DB 1ARec Control once at start once at low frequency completionfinal outcome collection once at high frequency completion
1 Demographics ARec x 3
Healthy Control once at start once at low frequency completion final outcome collection once at high frequency completion
1 Demographics ARec x 3
completed prior to assessments
English was chosen as the study language as a wider range of validated assessments exist in this language The AI used for speech analysis is also best suited for and trained 66 on English Lastly English is the most prolific language native secondary speakers in the world which will facilitate the speed of recruitment
Subjects who meet any of the following criteria will be excluded from study entry
Under the age of 18
NUMBER OF SUBJECTS PARTICIPATING IN THE STUDY Subjects will be randomly separated into six groups including control and healthy control with approximately 33 subjects per group A formal power analysis was performed using Gpower with parameters sourced from relevant seminal research Conner et al 2011 Godin et al 2011 The following parameters were used for the sample size analysis two-tailed directionality effect size of 030 a priori computation anticipated power of 095 and an error rate of 00023 Means difference tests between independent groups within the t-test family were utilized
RECRUITMENT PROCEDURE Recruitment into the mere-measurement study will be performed supported by Probando Probando is a previously approved patient recruitment service that specializes in online advertising All recruitment materials are uploaded to the ECS A description of the Probando recruitment service and procedures can be found as an attachment as well as the recruitment materials for all subjects including healthy controls and a screenshot of the currently inactive landing page As a part of their service Probando uses the study inclusion and exclusion criteria to screen potential interested subjects If they qualify and permit contact their contact information will be provided to the MUW researchers for direct outreach Therefore all study timings measures and data will be distributed and collected only by the study researchers Patients will be able to withdraw from the study at any time without providing a reason To limit potential bias an initial self-report of an official diagnosis is required to participate Additionally the patients will also confirm their diagnosis with a checkbox for the purpose of minimizing the risk of malingering patients If an individual is highly motivated to participate and does not suffer from a qualifying speech disorder they can still apply to participate as a healthy control Furthermore this sample would be more representative of a telemedicine community
DATA SOURCES
Participants and study data will be recorded in the study database Study data will be collected at defined time points see Section 15 using a single online format
SoSci survey wwwsoscisurveyde is a routinely used safe online questionnaire distribution and data retrieval platform Within this platform five links will be created one for each group These will connect subjects to the questionnaires and to the instructions for capturing the audio file
An email address for every participant will be required for communication and dissemination of participation credits All individuals with access to participants personal information are obligated to respect their privacy and only use and disclose their information as described in the informed consent document
Demographic information and mere-measurement study results are secured against unauthorized access Security measures reduce the risk of unauthorized individuals accessing subject personal information but such risks cannot be entirely eliminated All audio recordings will be stored only for the duration of the study Upon closure they will be deleted
The information collected from the mere-measurement study will be kept confidential Subject personal information will be stored safely at MUW and pseudonymized as discussed in the previous section
DATA COLLECTION
Online subjects will complete a battery of questionnaires totalling approximately 15-20 minutes of time following the informed consent Informed consent will be collected online via the SoSci survey tool The following parameters will be applied to the virtual informed consent
The patient information including the data protection section is displayed above the checkbox The patients are informed about what happens to their data their benefits and risks in sufficient detail but simple detail in this section
The checkbox says that patients have read and understood the text and that they agree
The patients will confirm their diagnosis with a checkbox for the purpose of minimizing the risk of malingering patients Depending on the group assigned a participant will have to complete this battery either 2 or 4 times The control and healthy group will complete only demographics questions and the audio recordings no PROMs will be collected The four intervention groups will be randomized using a digital randomization tool provided by the MUW httpswwwmeduniwienacatrandomizer
All patients across all intervention groups will complete the read-aloud activity prior to the first collection of PROMs This will serve as the baseline for later comparison Following the first recording all subsequent recordings will be completed after completing the PROMs An electronic bank transfer form MUW standard bank form will be emailed to participants at the end of the study to complete the 50 transfer These electronic records will be immediately destroyed upon successful completion
DATA MANAGEMENT Patient-reported data will be captured using SoSci survey with an account owned by the Center for Outcomes Research These data will not be transferred outside of the MUW Data transfers between the investigators of this study will be managed using procedures described in a jointly developed Data Transfer Plan All data transferred between the two MUW centers speech pathology and outcome research will be identified only by a subject ID code unless otherwise consented by patients and agreed upon in the Data Transfer Plan
DATA QUALITY ASSURANCE Patients will consent that pseudonymized patient data will be hosted and analysed at the MUW MUW will not share the data with any third parties or collaborators MUW regularly processes medical data and is subject to the GDPR requirements MUW is responsible for data quality and will perform oversight of the data management of this study Investigators and study coordinators will receive an initial training session on the protocol study flow study database survey tool documentation and expectations and any applicable study processes Access to data for secondary use cases will not be enabled
SOURCE DATA DOCUMENTATION
Source documents electronic are those in which participant data are recorded and documented for the first time The source documentation for this study will be
Participant demographic information and eligibility assessment
Completed Informed Consent Forms
Audio recordings
Completed PROMs
Thus it may be that asking patients about their intent to have an operation increases the likelihood of them opting for it or that asking them about their exercise increases their physical activity level If so this may have significant implications for the effect of routinely collecting patient-reported outcomes PROs as well as for utilizing measurements as interventions However before value can be attached to such an effect first the presence and strength must be evaluated in the patient-specific context
To date no mere-measurement effect factors have been investigated in the context of patient-reported outcomes measures PROMs and particularly not in regard to how they may influence patient perceptions and behaviours Therefore exploration of this family of effects must be reduced to a few key anticipated features namely emotional valence positivenegative and frequency For instance would wording a cleft-lip question negatively such as I do not like my face actually decrease the patients preference for their own face and does repeated exposure to this question increase the magnitude of the effect
This randomized controlled trial RCT review will be the first to the authors knowledge to examine if measuring patient- reported outcomes directly effects their corresponding behaviour and if this effect can be attributed in part to item wording andor frequency of exposure
PROMs Speech Disorders Three recent reviews regarding patient-reported outcomes in speech pathologies were identified 8910 Francis et al list a number of PRO measures that were designed for administration with subjects with any kind of voice disorders The Evaluating Voice Disability-Quality of Life Questionaire EVD-QOL aims at assessing the general range of functional problems in voice disorders The 30-items Voice Handicap Index VHI and its 10-items short version VHI-10 aim at providing a psychometrically robust voice diasabilityhandicap inventory The Voice-Related Quality of Life V-RQOL aims at measuring the impact of voice problems on the quality of life The Voice Activity and Participation Profile VAPP aims at identifying voice activity limitation and participation restriction separately The Voice Symptom Scale VoiSS is an inventory of voice symptoms for assessing baseline pathology and response to change The Communicative Participation Item Bank CPIB aims at assessing communication participation in all kinds of communication disorders The Voice Self-Efficacy Questionnaire VSEQ monitors self-efficacy in individuals with self-declared voice problems before and after interventions The Vocal Fatigue Handicap Questionnaire VFHQ and the Vocal Fatigue Index VFI aim at reflecting vocal fatigue
Additional PROs include the Aging Voice Index the Evaluation of the Ability to Sing Easily the Glottal Function Index the Linear Analog Scale of Assessment of Voice Quality the Speech Disability Questionnaire the Trans Woman Voice Questionnaire the Vocal Cord Dysfunction Questionnaire and the Vocal Tract Discomfort Scale Slavych Zraick Ruleman 2021
The researchers have opted to use the CPIB and the VHI because these are well established and the former covers all kinds of communication disorders while the VHI is using particularly negative wording in its original form
12 STUDY RATIONALE The purpose of the mere-measurement study is to identify the most advantageous way to measure outcomes for patients This will be accomplished by collecting measures on the same topic at different time intervals and with different wording of questions The findings of this study should help researchers and clinicians collect measurements from patients in the least burdensome and most beneficial manner possible
The primary objective of the mere-measurement study is to assess the effects of different collection methods on the responders wellbeing
The secondary objectives of this study are to
What frequency of collection is best for patients
What style of question wording is best for patients
Research Questions
Does the assigned positivity or negativity of an item effect patient perception or behaviour on the topic inquired
Does frequency of exposure to an item have an effect on patient perception or behaviour of the topic inquired
Hypotheses
H1 The more a patient reads and responds to questions about their speech condition the more their speech condition will be affected
H2 The directionality of impact on a speech condition will be congruent with the emotional valence of the items used
STUDY DESIGN Once a subject has agreed to participate in this study they will be asked to complete online questionnaires as well as record their voice reading a collection of random words 2-4 times
This study follows a 2x2 design Participants will be randomly assigned to one of four groups Randomization will be accomplished by using the MUW randomizer Participants will be stratified by education and speech disorder type The healthy case control group will undergo case matching to ensure comparability across groups Each group will receive two brief speech pathology severity questionnaires but at different frequencies and with slight adjustments to the wording Depending on the experimental group a subject will complete the questionnaires either two or four times separated each time by one week The questionnaires in all groups will take approximately 15 minutes to complete Lastly at the very start and once at the very end of the study every participant will also be asked to record a brief 45 second audio file in the online survey as well as complete two additional psychological questionnaires
The measures in this study cover the following tools complete measures are uploaded in the ECS
A patient-reported outcome on voice health - Voice Handicap Index VHI or Voice Handicap Index Positively adapted VHI-PA
A patient-reported outcome on speech health - Communicative Participation Item Bank CPIB or Communicative Participation Item Bank Positively adapted CPIB-PA
A self-esteem stability scale - Self-Esteem Stability Scale SESS
A self-esteem scale - Rosenberg Self-Esteem Scale RSS
Two question measure of disease impact 2DB
A single-question measure of disease activity 1DS
Audio recording of text read aloud ARec
Study population All patients with Muscle tension dysphonia Inducible laryngeal obstruction Amyotrophic lateral sclerosis ALS suffering from a stroke or other brain injurydamagetrauma aphasia dysarthria and Parkinsons disease will be targeted for recruitment There are no geographic location requirements The participation schedule can be found below Patients will be informed of the schedule in advance A subject must complete any respective sampling epoch within 48 hours of the prescribed date in order to qualify as completed Subjects must also have strong English skills and be technologically savvy to participate Only adults will be included in the study
Study Design Flow Group 1 High frequency-negative 1 week between each collection
1 Demographics VHI CPIB SESS RSS 1DS 1DB ARec
2 VHI CPIB SE SSE 1DS 2DB ARec
3 VHI CPIB SE SSE 1DS 2DB ARec
4 VHI CPIB SE SSE 1DS 2DB ARec Group 2 High frequency-positive 1 week between each collection
-- --
1 Demographics VHI-PA CPIB-PA SESS RSS 1DS 2DB ARec
2 VHI-PA CPIB-PA SE SSE 1DS 2DB ARec
3 VHI-PA CPIB-PA SE SSE 1DS 2DB ARec
4 VHI-PA CPIB-PA SE SSE 1DS 2DB ARec Group 3 Low frequency-negative 2 weeks between each collection
1 Demographics VHI CPIB SESS RSS 1DS 2DB ARec 2 VHI CPIB SE SSE 1DS 2DB ARec Group 4 Low frequency-positive 2 weeks between each collection
1 Demographics VHI-PA CPIB-PA SESS RSS 1DS 2DB 1ARec
2 VHI-PA CPIB-PA SE SSE 1DS 2DB 1ARec Control once at start once at low frequency completionfinal outcome collection once at high frequency completion
1 Demographics ARec x 3
Healthy Control once at start once at low frequency completion final outcome collection once at high frequency completion
1 Demographics ARec x 3
completed prior to assessments
English was chosen as the study language as a wider range of validated assessments exist in this language The AI used for speech analysis is also best suited for and trained 66 on English Lastly English is the most prolific language native secondary speakers in the world which will facilitate the speed of recruitment
Subjects who meet any of the following criteria will be excluded from study entry
Under the age of 18
NUMBER OF SUBJECTS PARTICIPATING IN THE STUDY Subjects will be randomly separated into six groups including control and healthy control with approximately 33 subjects per group A formal power analysis was performed using Gpower with parameters sourced from relevant seminal research Conner et al 2011 Godin et al 2011 The following parameters were used for the sample size analysis two-tailed directionality effect size of 030 a priori computation anticipated power of 095 and an error rate of 00023 Means difference tests between independent groups within the t-test family were utilized
RECRUITMENT PROCEDURE Recruitment into the mere-measurement study will be performed supported by Probando Probando is a previously approved patient recruitment service that specializes in online advertising All recruitment materials are uploaded to the ECS A description of the Probando recruitment service and procedures can be found as an attachment as well as the recruitment materials for all subjects including healthy controls and a screenshot of the currently inactive landing page As a part of their service Probando uses the study inclusion and exclusion criteria to screen potential interested subjects If they qualify and permit contact their contact information will be provided to the MUW researchers for direct outreach Therefore all study timings measures and data will be distributed and collected only by the study researchers Patients will be able to withdraw from the study at any time without providing a reason To limit potential bias an initial self-report of an official diagnosis is required to participate Additionally the patients will also confirm their diagnosis with a checkbox for the purpose of minimizing the risk of malingering patients If an individual is highly motivated to participate and does not suffer from a qualifying speech disorder they can still apply to participate as a healthy control Furthermore this sample would be more representative of a telemedicine community
DATA SOURCES
Participants and study data will be recorded in the study database Study data will be collected at defined time points see Section 15 using a single online format
SoSci survey wwwsoscisurveyde is a routinely used safe online questionnaire distribution and data retrieval platform Within this platform five links will be created one for each group These will connect subjects to the questionnaires and to the instructions for capturing the audio file
An email address for every participant will be required for communication and dissemination of participation credits All individuals with access to participants personal information are obligated to respect their privacy and only use and disclose their information as described in the informed consent document
Demographic information and mere-measurement study results are secured against unauthorized access Security measures reduce the risk of unauthorized individuals accessing subject personal information but such risks cannot be entirely eliminated All audio recordings will be stored only for the duration of the study Upon closure they will be deleted
The information collected from the mere-measurement study will be kept confidential Subject personal information will be stored safely at MUW and pseudonymized as discussed in the previous section
DATA COLLECTION
Online subjects will complete a battery of questionnaires totalling approximately 15-20 minutes of time following the informed consent Informed consent will be collected online via the SoSci survey tool The following parameters will be applied to the virtual informed consent
The patient information including the data protection section is displayed above the checkbox The patients are informed about what happens to their data their benefits and risks in sufficient detail but simple detail in this section
The checkbox says that patients have read and understood the text and that they agree
The patients will confirm their diagnosis with a checkbox for the purpose of minimizing the risk of malingering patients Depending on the group assigned a participant will have to complete this battery either 2 or 4 times The control and healthy group will complete only demographics questions and the audio recordings no PROMs will be collected The four intervention groups will be randomized using a digital randomization tool provided by the MUW httpswwwmeduniwienacatrandomizer
All patients across all intervention groups will complete the read-aloud activity prior to the first collection of PROMs This will serve as the baseline for later comparison Following the first recording all subsequent recordings will be completed after completing the PROMs An electronic bank transfer form MUW standard bank form will be emailed to participants at the end of the study to complete the 50 transfer These electronic records will be immediately destroyed upon successful completion
DATA MANAGEMENT Patient-reported data will be captured using SoSci survey with an account owned by the Center for Outcomes Research These data will not be transferred outside of the MUW Data transfers between the investigators of this study will be managed using procedures described in a jointly developed Data Transfer Plan All data transferred between the two MUW centers speech pathology and outcome research will be identified only by a subject ID code unless otherwise consented by patients and agreed upon in the Data Transfer Plan
DATA QUALITY ASSURANCE Patients will consent that pseudonymized patient data will be hosted and analysed at the MUW MUW will not share the data with any third parties or collaborators MUW regularly processes medical data and is subject to the GDPR requirements MUW is responsible for data quality and will perform oversight of the data management of this study Investigators and study coordinators will receive an initial training session on the protocol study flow study database survey tool documentation and expectations and any applicable study processes Access to data for secondary use cases will not be enabled
SOURCE DATA DOCUMENTATION
Source documents electronic are those in which participant data are recorded and documented for the first time The source documentation for this study will be
Participant demographic information and eligibility assessment
Completed Informed Consent Forms
Audio recordings
Completed PROMs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None