ENGAGE: Engagement 2.0 Forms of Consent for Data (re-)Use
Study Details
Study Description
Brief Summary
The objective of this qualitative study is to create a better understanding of patients' mental model of web 2.0 based consent types (such as Dynamic Consent). The researchers will focus especially on those people who - plausibly - require adjusted communication particularities and interaction modalities due to a cognitive impairment stemming from a neurodegenerative disease. Taking into account the specific characteristics of patients with MCI due to AD and mild dementia due to AD, the goal of this study is to investigate how to communicate according to patients' personal skills and capabilities and identify both the proper support mechanisms for engagement 2.0 consent as well as feedback mechanisms (return of research results). Through a focus group study setup, this study will discern design requirements and propose design recommendations for the (future) development of engagement 2.0 interfaces.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The increasingly data-driven character of digital health & clinical research has put traditional patient consent models under heightened scrutiny. Static, paper-based consent forms have become hopelessly outdated in a complex health research landscape which is marked by (a) an unprecedented prevalence of (multimodal, patient-specific) data, (b) increased (re-)use of routinely collected clinical data for secondary purposes; and (c) incremental usage of novel data-driven research methods such as Machine Learning. Patient involvement and consent should be (and is being) revised against the backdrop of this new data-driven clinical ecosystem and its particularities. Drawing from the interactive "web 2.0" model, technology-driven "engagement 2.0" approaches have been proposed to move away from static, mono-directional and single point consent, towards more interactive, granular and dynamic forms of consent. Over the past years, multiple projects (e.g. RUDY, PEER, SPRAINED, CTRL) have prototyped and implemented such engagement 2.0 consent models. While high-level user feedback was overall positive, attempts to more deeply understand patients' or databank participants' views on sharing their data for research purposes through such interfaces are scarce. Moreover, no studies have looked at specific subsets of patients who might require additional attention in this context, such as those who suffer from cognitive impairing conditions. Through focus groups, this study aims to create a better understanding of patients' mental model of web 2.0 based consent types and especially of those people who - plausibly - require adjusted communication particularities and interaction modalities due to a cognitive impairment stemming from a neurodegenerative disease. Taking into account the specific characteristics of patients with Alzheimer's disease (AD), the goal is to investigate how to communicate according to patients' personal skills and capabilities and identify both the proper support mechanisms for engagement 2.0 consent as well as feedback mechanisms (return of research results).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with mild MCI due to AD All three 'arms' take part in a similar focus group. The conversation topics will be the same (with the aim to gauge interpretations / needs / thoughts / feelings with regard data usage for research and the role engagement 2.0 interfaces (Dynamic Consent) may play in this. |
Other: Showing an existing Dynamic Consent (computer interface) as prompt
An existing Dynamic Consent interface will be shown as a prompt halfway through the focus group sessions.
|
| Patient's with mild dementia due to AD All three 'arms' take part in a similar focus group. The conversation topics will be the same (with the aim to gauge interpretations / needs / thoughts / feelings with regard data usage for research and the role engagement 2.0 interfaces (Dynamic Consent) may play in this. |
Other: Showing an existing Dynamic Consent (computer interface) as prompt
An existing Dynamic Consent interface will be shown as a prompt halfway through the focus group sessions.
|
| Subjects with no diagnosed cognitive impairment but first-degree relative with AD All three 'arms' take part in a similar focus group. The conversation topics will be the same (with the aim to gauge interpretations / needs / thoughts / feelings with regard data usage for research and the role engagement 2.0 interfaces (Dynamic Consent) may play in this. |
Other: Showing an existing Dynamic Consent (computer interface) as prompt
An existing Dynamic Consent interface will be shown as a prompt halfway through the focus group sessions.
|
Outcome Measures
Primary Outcome Measures
- Qualitative data: interpretations / opinions / needs / thoughts / feelings with regard to clinical data usage and dynamic consent. [1-2 months. During the focus groups, answers given by participants will be audiorecorded and later transcribed to be thematically analysed.]
Collected in response to questions from an open-ended questionnaire (interview guide), the outcome of the focus groups will be rich qualitative data that will provide a better understanding of patients' assumed skills, capabilities and preferences necessary to meaningfully interact with "engagement 2.0 (dynamic consent) interfaces" for clinical data usage consent.
Eligibility Criteria
Criteria
Inclusion Criteria:
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no diagnosed cognitive impairment but first-degree relative with AD
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mild cognitive impairment due to AD (diagnosed according to the NIA/AA diagnostic criteria)
-
mild dementia due to AD (diagnosed according to the NIA/AA diagnostic criteria)
Exclusion Criteria:
- Patients with moderate to severe dementia due to AD, defined as MMSE total score 20/30 or lower
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitair Ziekenhuis Brussel (UZB) | Jette | Brussel | Belgium | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Lawrence Van den Bogaert, Master's, VUB (Vrije Universiteit Brussel)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Engage 2.0