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The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.
The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Long Form Consent | No Intervention | Participants will receive the traditional long-form consent form. | |
| ResearchKit Consent | Experimental | Participants will receive the Apple ResearchKit consent form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ResearchKit Consent | Other | Multi-tiered consent form using the Apple ResearchKit Platform. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant comprehension, as measured by Qualtrics survey | Participants will complete a questionnaire about the consent form after reading through the consent which will assess their comprehension of the contents of the consent process. | at study conclusion, an average of 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Tanaka, MD | Duke Health | Principal Investigator |
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