Attitude to ComputersNCT03063268
An Interactive Patient-Centered Consent for Research Using Medical Records
A study testing Trust-Enhanced Messaging on E-Consent, Interactive features on E-Consent and Standard E-Consent in people with Attitude to Computers and Attitude of Health Personnel, run by University of Florida at 1 site in United States.
Trial summary
The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attitude to Computers, Attitude of Health Personnel, Researcher-Subject Relations
- What is being tested?
- Trust-Enhanced Messaging on E-Consent, Interactive features on E-Consent and Standard E-Consent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 734 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 9 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a scheduled medical visit at a UF Family Medicine clinic
- Capacitated, english-speaking patients
- Ages 18 and over
- Patients who meets the above criteria and is willing to consent to participate in the trial.
Who cannot join
- Patients who do not complete the UF IRB approved informed consent form
- Patients under the age of 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration of informed consent and patient preferences about research use of clinical information. This study will design an electronic consent application intended to improve patients' satisfaction with and understanding of consent for research using their EHR data. The electronic application will provide interactive functionality that creates a virtual, patient-centered discussion with patients about research that uses EHR data. Also, to correct potential misconceptions and increase informedness, the application will present trust-enhancing messages that highlight facts about research regulations, researcher training, and data protections. This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research. This first phase of this project (IRB#:201500678) was innovative because it created a virtual, patient-centered discussion about research using EHR data. Moreover, this project produced a consent application that clinicians and researchers will use in this phase (Phase two) of the trial as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs. Overall, this study will improve understanding of how to best give patients information about research that uses their health records and data. With this understanding, this study will develop a new computer application that patients can use in their doctors' offices. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research.
Read the detailed description
This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content.
Conceptually, the hypothesized effectiveness of this study's new consent application relies on two constructs, interactivity and trust. Many studies have identified the importance of trust in researchers when it comes to people's willingness to participate in research. Moreover, trust in the source of information is critical to participants' evaluations of risk information. And, risk information is an important element of the research consent process. Thus, highlighted relevant messages to participants at the outset of a research consent process. It is expected that these messages will not coerce participants nor will they dramatically alter participants' general trust in researchers. More importantly, empirically assessments of both of these expectations to ensure the application delivers an ethically appropriate consenting experience. However, it is expected that presenting key facts about research data protections, researcher training, and research regulations will increase the likelihood that participants will be willing to learn about research using medical records. In turn, this will increase participants' understanding and help them make a more informed decision. In the absence of these trust-related messages, it is expected that many participants will simply disengage from the details of the consent information and thus make a less informed decision about participating. Next, the investigators' use of interactivity is supported by research on the effectiveness of communications that interactively deliver detail, empower audiences, and allow a self - discovery process. Indeed, an interactive, person-to-person consent process is the standard approach in clinical trials. Therefore, in the new consent application, the interface will allow participants to interactively explore the details that are most important for their personal understanding of research using EHRs and most relevant to their personal information needs and satisfaction with the consent decision. Without this interactive information exploration, which is essentially dynamically tailored to their personal information needs, participants are more likely to be overwhelmed by the volume of information presented and unable to obtain the information they want most. Under these circumstances, participants' overall understanding of the consent information is likely to decrease, and they are likely to make less satisfactory decisions. There are two specific hypotheses: (1) compared to the standard consent, the interactive consent will lead to increased decisional satisfaction and understanding of the consent; and (2) compared to the interactive consent, the interactive, trust-enhanced consent will lead to increased decisional satisfaction and understanding of the consent.
- Conditions
- Attitude to Computers, Attitude of Health Personnel, Researcher-Subject Relations, Trust, Communication Research
- Being tested
- Trust-Enhanced Messaging on E-Consent, Interactive features on E-Consent, Standard E-Consent
- Keywords
- Electronic Consent, Human Behavior, Bioethics, Research Ethics, Electronic Medical Records (EMR), Electronic Health Records (EHR), Informed Consent Form, Interactive Consent, Health Record Data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trust-Enhanced Messaging on E-ConsentBehavioural
Also called Trust-Enhanced E-Consent
Messaging with trust-enhanced modification to the language that the research team has identified as beneficial additional knowledge to provide to participants. This messaging was reviewed by participants from Phase I and edited as suggested.
Interactive features on E-ConsentBehavioural
Also called Interactive E-Consent
Interactive hyperlinks to open up to further information for key words that participants from Phase I and prototype design and testing have identified as gaps in subject knowledge and provision of information to subjects.
Standard E-ConsentBehavioural
Standard consent currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects.
| Study group | Role | What they receive |
|---|---|---|
| Trust-Enhanced Messaged with Interactive Features on E-Consent | Experimental | Messaging with trust-enhanced modification to the language that the research team has identified as beneficial additional knowledge to provide to participants. This messaging was reviewed by participants from Phase I and edited as suggested. Receives: Behavioral: Trust-Enhanced Messaging on E-Consent; Behavioral: Interactive features on E-Consent; Behavioral: Standard E-Consent |
| Interactive Features on E-Consent | Experimental | Interactive hyperlinks to open up to further information for key words that participants from Phase I and prototype design and testing have identified as gaps in subject knowledge and provision of information to subjects. Receives: Behavioral: Interactive features on E-Consent; Behavioral: Standard E-Consent |
| Standard E-Consent | Active comparator | Standardized text currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects. Receives: Behavioral: Standard E-Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Satisfaction with consent decision
Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)
Measured: Immediate at baseline
Change from Baseline Satisfaction with consent decision
Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)
Measured: 1-week follow-up from Baseline
Baseline Understanding of consent content
Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)*
Measured: Immediate at Baseline
Change from Baseline Understanding of consent content
Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)*
Measured: 1-week follow-up from Baseline
Change from Baseline Understanding of consent content
Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)*
Measured: 6-month follow-up from Baseline
Secondary outcomes (22)
Baseline Perceived Voluntariness
Decision Making Control instrument to assess voluntary consent (Miller et. al.,2011); 9-items, 5-point Likert Scale (Strongly disagree-Strongly Agree)
Measured: Immediate at Baseline
Change from Baseline Perceived Voluntariness
Decision Making Control instrument to assess voluntary consent (Miller et. al.,2011); 9-items, 5-point Likert Scale (Strongly disagree-Strongly Agree)
Measured: 1-week follow-up from Baseline
Baseline Trust in medical researchers
Trust In Medical Researchers Scale (Mainous et al. 2006); 12 items, 5-point Likert scale (strongly disagree-strongly agree); Aggregate scores range from 0-48 Sub-analysis of the two Trust in Medical Researchers subscales (or TIMRS)- Participant Deception; Researcher Honesty.
Measured: Prior to consent
Change from Baseline Trust in medical researchers
Trust In Medical Researchers Scale (Mainous et al. 2006); 12 items, 5-point Likert scale (strongly disagree-strongly agree); Aggregate scores range from 0-48 Sub-analysis of the two Trust in Medical Researchers subscales (or TIMRS)- Participant Deception; Researcher Honesty.
Measured: Immediate at Baseline
Change from Baseline Trust in medical researchers
Trust In Medical Researchers Scale (Mainous et al. 2006); 12 items, 5-point Likert scale (strongly disagree-strongly agree); Aggregate scores range from 0-48 Sub-analysis of the two Trust in Medical Researchers subscales (or TIMRS)- Participant Deception; Researcher Honesty.
Measured: 1-week follow-up from Baseline
Change from Baseline Trust in medical researchers
Trust In Medical Researchers Scale (Mainous et al. 2006); 12 items, 5-point Likert scale (strongly disagree-strongly agree); Aggregate scores range from 0-48 Sub-analysis of the two Trust in Medical Researchers subscales (or TIMRS)- Participant Deception; Researcher Honesty.
Measured: 6-month follow-up from Baseline
Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Consent for past and future EHR data to be shared with researchers for IRB-approved studies (yes/no); Consent for EHR to be linked with biospecimen data and released to researchers (yes/no)
Measured: Immediate at Baseline
Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Consent for past and future EHR data to be shared with researchers for IRB-approved studies (yes/no); Consent for EHR to be linked with biospecimen data and released to researchers (yes/no)
Measured: 1-week follow-up from Baseline
Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Consent for past and future EHR data to be shared with researchers for IRB-approved studies (yes/no); Consent for EHR to be linked with biospecimen data and released to researchers (yes/no)
Measured: 6-month follow-up from Baseline
Engagement with consent information
Time spent using consent application and click activity; Focused immersion in information (Agarwal \& Karahanna 2000); 5 items, 5-point Likert scale (strongly disagree-strongly agree)
Measured: Immediate at Baseline (only)
Baseline Numeracy Abilities
Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)
Measured: Immediate at Baseline
Change from Baseline Numeracy Abilities
Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)
Measured: 1-week follow-up from Baseline
Change from Baseline Numeracy Abilities
Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)
Measured: 6-month follow-up from Baseline
Baseline Possibility of using a Computer Application
Ease of use, comfort with, and improvements associated with Computer application use
Measured: Immediate at Baseline
Change from Baseline Possibility of using a Computer Application
Ease of use, comfort with, and improvements associated with Computer application use
Measured: 1-week follow-up from Baseline
Change from Baseline Possibility of using a Computer Application
Ease of use, comfort with, and improvements associated with Computer application use
Measured: 6-month follow-up from Baseline
Baseline Using new Computer Applications
Experiences with computer applications that the participant has never used before
Measured: Immediate at Baseline
Change from Baseline Using new Computer Applications
Experiences with computer applications that the participant has never used before
Measured: 1-week follow-up from Baseline
Change from Baseline Using new Computer Applications
Experiences with computer applications that the participant has never used before
Measured: 6-month follow-up from Baseline
Baseline Dissemination & Access of Personal Health Records and Health Information
Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records
Measured: Immediate at Baseline
Change from Baseline Dissemination & Access of Personal Health Records and Health Information
Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records
Measured: 1-week follow-up from Baseline
Change from Baseline Dissemination & Access of Personal Health Records and Health Information
Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records
Measured: 6-month follow-up from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start6 Nov 2017
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attitude to ComputersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 734 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Richard M. Fairbanks School of Public Health AT IUPUI, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ray E Moseley, Ph.D, Principal investigator, University of Florida- College of Medicine- Department of Community Health & Family MedicineChristopher A Harle, Ph.D, Principal investigator, Indiana University- Purdue University Indianapolis- Richard M. Fairbanks School of Public HealthArch G Mainous, Ph.D, Principal investigator, University of Florida- Department of Health Services Research, Management and Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063268
- Sponsor's protocol ID
- IRB201602061 - N
- Other IDs
- R01HD086700
- Status last verified
- Aug 2019
- First submitted
- 16 Feb 2017
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harle CA, Golembiewski EH, Rahmanian KP, Brumback B, Krieger JL, Goodman KW, Mainous AG, Moseley RE. Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial. J Am Med Inform Assoc. 2019 Jul 1;26(7):620-629. doi: 10.1093/jamia/ocz015.
PubMed 30938751
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive Patient-Centered Consent for Research Using Medical Records
- ClinicalTrials.gov ID
- NCT03063268
- Acronym / sponsor ID
- IRB201602061 - N
- Conditions
- Attitude to Computers, Attitude of Health Personnel, Researcher-Subject Relations, Trust, Communication Research
- Keywords
- Electronic Consent, Human Behavior, Bioethics, Research Ethics, Electronic Medical Records (EMR), Electronic Health Records (EHR), Informed Consent Form, Interactive Consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 734 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Richard M. Fairbanks School of Public Health AT IUPUI, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration of informed consent and patient preferences about research use of clinical information. This study will design an electronic consent application intended to improve patients' satisfaction with and understanding of consent for research using their EHR data. The electronic application will provide interactive functionality that creates a virtual, patient-centered discussion with patients about research that uses EHR data. Also, to correct potential misconceptions and increase informedness, the application will present trust-enhancing messages that highlight facts about research regulations, researcher training, and data protections. This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research. This first phase of this project (IRB#:201500678) was innovative because it created a virtual, patient-centered discussion about research using EHR data. Moreover, this project produced a consent application that clinicians and researchers will use in this phase (Phase two) of the trial as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs. Overall, this study will improve understanding of how to best give patients information about research that uses their health records and data. With this understanding, this study will develop a new computer application that patients can use in their doctors' offices. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research.
Detailed description
This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content.
Conceptually, the hypothesized effectiveness of this study's new consent application relies on two constructs, interactivity and trust. Many studies have identified the importance of trust in researchers when it comes to people's willingness to participate in research. Moreover, trust in the source of information is critical to participants' evaluations of risk information. And, risk information is an important element of the research consent process. Thus, highlighted relevant messages to participants at the outset of a research consent process. It is expected that these messages will not coerce participants nor will they dramatically alter participants' general trust in researchers. More importantly, empirically assessments of both of these expectations to ensure the application delivers an ethically appropriate consenting experience. However, it is expected that presenting key facts about research data protections, researcher training, and research regulations will increase the likelihood that participants will be willing to learn about research using medical records. In turn, this will increase participants' understanding and help them make a more informed decision. In the absence of these trust-related messages, it is expected that many participants will simply disengage from the details of the consent information and thus make a less informed decision about participating. Next, the investigators' use of interactivity is supported by research on the effectiveness of communications that interactively deliver detail, empower audiences, and allow a self - discovery process. Indeed, an interactive, person-to-person consent process is the standard approach in clinical trials. Therefore, in the new consent application, the interface will allow participants to interactively explore the details that are most important for their personal understanding of research using EHRs and most relevant to their personal information needs and satisfaction with the consent decision. Without this interactive information exploration, which is essentially dynamically tailored to their personal information needs, participants are more likely to be overwhelmed by the volume of information presented and unable to obtain the information they want most. Under these circumstances, participants' overall understanding of the consent information is likely to decrease, and they are likely to make less satisfactory decisions. There are two specific hypotheses: (1) compared to the standard consent, the interactive consent will lead to increased decisional satisfaction and understanding of the consent; and (2) compared to the interactive consent, the interactive, trust-enhanced consent will lead to increased decisional satisfaction and understanding of the consent.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trust-Enhanced Messaged with Interactive Features on E-Consent | Experimental | Behavioral: Trust-Enhanced Messaging on E-Consent, Behavioral: Interactive features on E-Consent, Behavioral: Standard E-ConsentMessaging with trust-enhanced modification to the language that the research team has identified as beneficial additional knowledge to provide to participants. This messaging was reviewed by participants from Phase I and edited as suggested. |
| Interactive Features on E-Consent | Experimental | Behavioral: Interactive features on E-Consent, Behavioral: Standard E-ConsentInteractive hyperlinks to open up to further information for key words that participants from Phase I and prototype design and testing have identified as gaps in subject knowledge and provision of information to subjects. |
| Standard E-Consent | Active comparator | Behavioral: Standard E-ConsentStandardized text currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a scheduled medical visit at a UF Family Medicine clinic
- Capacitated, english-speaking patients
- Ages 18 and over
- Patients who meets the above criteria and is willing to consent to participate in the trial.
Key exclusion criteria (2 listed)
- Patients who do not complete the UF IRB approved informed consent form
- Patients under the age of 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trust-Enhanced Messaging on E-ConsentAlso: Trust-Enhanced E-ConsentMessaging with trust-enhanced modification to the language that the research team has identified as beneficial additional knowledge to provide to participants. This messaging was reviewed by participants from Phase I and edited as suggested. | Behavioural | Trust-Enhanced Messaged with Interactive Features on E-Consent |
| Interactive features on E-ConsentAlso: Interactive E-ConsentInteractive hyperlinks to open up to further information for key words that participants from Phase I and prototype design and testing have identified as gaps in subject knowledge and provision of information to subjects. | Behavioural | Interactive Features on E-Consent, Trust-Enhanced Messaged with Interactive Features on E-Consent |
| Standard E-ConsentStandard consent currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects. | Behavioural | Interactive Features on E-Consent, Standard E-Consent, Trust-Enhanced Messaged with Interactive Features on E-Consent |
Primary outcome
Baseline Satisfaction with consent decision
Time frame: Immediate at baseline
Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)
Change from Baseline Satisfaction with consent decision
Time frame: 1-week follow-up from Baseline
Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)
Baseline Understanding of consent content
Time frame: Immediate at Baseline
Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)*
Change from Baseline Understanding of consent content
Time frame: 1-week follow-up from Baseline
Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)*
Change from Baseline Understanding of consent content
Time frame: 6-month follow-up from Baseline
Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)*
22 secondary outcomes
Baseline Perceived Voluntariness
Time frame: Immediate at Baseline
Change from Baseline Perceived Voluntariness
Time frame: 1-week follow-up from Baseline
Baseline Trust in medical researchers
Time frame: Prior to consent
Change from Baseline Trust in medical researchers
Time frame: Immediate at Baseline
Change from Baseline Trust in medical researchers
Time frame: 1-week follow-up from Baseline
Change from Baseline Trust in medical researchers
Time frame: 6-month follow-up from Baseline
Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Time frame: Immediate at Baseline
Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Time frame: 1-week follow-up from Baseline
Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Time frame: 6-month follow-up from Baseline
Engagement with consent information
Time frame: Immediate at Baseline (only)
Baseline Numeracy Abilities
Time frame: Immediate at Baseline
Change from Baseline Numeracy Abilities
Time frame: 1-week follow-up from Baseline
Change from Baseline Numeracy Abilities
Time frame: 6-month follow-up from Baseline
Baseline Possibility of using a Computer Application
Time frame: Immediate at Baseline
Change from Baseline Possibility of using a Computer Application
Time frame: 1-week follow-up from Baseline
Change from Baseline Possibility of using a Computer Application
Time frame: 6-month follow-up from Baseline
Baseline Using new Computer Applications
Time frame: Immediate at Baseline
Change from Baseline Using new Computer Applications
Time frame: 1-week follow-up from Baseline
Change from Baseline Using new Computer Applications
Time frame: 6-month follow-up from Baseline
Baseline Dissemination & Access of Personal Health Records and Health Information
Time frame: Immediate at Baseline
Change from Baseline Dissemination & Access of Personal Health Records and Health Information
Time frame: 1-week follow-up from Baseline
Change from Baseline Dissemination & Access of Personal Health Records and Health Information
Time frame: 6-month follow-up from Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Derived from this study: PubMed 30938751Harle CA, Golembiewski EH, Rahmanian KP, Brumback B, Krieger JL, Goodman KW, Mainous AG, Moseley RE. Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial. J Am Med Inform Assoc. 2019 Jul 1;26(7):620-629. doi: 10.1093/jamia/ocz015.
- Individual participant dataSharing planned: Undecided
Related trials for Attitude to Computers
Recruiting
Clinical and Objective Psychiatric Analyses in Severe Depression.
Depression
Recruiting
SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
Traumatic Brain Injury (TBI) Patients, Severe Traumatic Brain Injury
Recruiting
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
Amyotrophic Lateral Sclerosis, Neuromuscular Disease
Recruiting
Aurora: AI-Based Narrative Intervention to Support Emotional Well-Being in Clinical and Non-Clinical Populations
Institutionalization, Elderly
Recruiting
Train Your Brain 2.0 - Improving Memory and Decision Making Among Youth
Behavior, Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray E Moseley, Ph.D principal investigator
University of Florida- College of Medicine- Department of Community Health & Family Medicine
Christopher A Harle, Ph.D principal investigator
Indiana University- Purdue University Indianapolis- Richard M. Fairbanks School of Public Health
Arch G Mainous, Ph.D principal investigator
University of Florida- Department of Health Services Research, Management and Policy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trust-Enhanced Messaging on E-Consent, Interactive features on E-Consent and Standard E-Consent in people with Attitude to Computers and Attitude of Health Personnel, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Satisfaction with consent decision (time frame: Immediate at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03063268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.