Clinical trial NCT05229978: Engagement 2.0 Forms of Consent for Data (re-)Use
Official title: Engagement 2.0 Forms of Consent for Data (re-)Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease, Early Onset
Mild Cognitive Impairment
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with mild MCI due to AD
* Patient's with mild dementia due to AD
* Subjects with no diagnosed cognitive impairment but first-degree relative with AD

Brief summary: The objective of this qualitative study is to create a better understanding of patients' mental model of health data engagement interfaces and tools (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 dementia, 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 \& interview setup, this study will discern design requirements and propose design recommendations for the (future) development of health data engagement interfaces.

Detailed description: While unprecedented amounts of multimodal health data become increasingly available and their secondary use in clinical and (bio)medical research holds great promise, people's agency over this data is in contention. In the context of biobank research, patient-centered initiatives such as 'dynamic consent' have been proposed as a way to provide people with ownership over their health data by allowing for granular expression of their consent preferences using a digital interface. Although such interfaces have been positively assessed within their original biobank context, more heterogeneous audiences will need to be considered if such a socio-technical tool is to be adopted widely and provide people ownership over their electronic medical records. One subset of people that will require adjusted functionalities and interaction modalities in this regard are those with a cognitive impairing condition like dementia, given the illness' consequences on decision making capacity. This study qualitatively explores the user \& social requirements of a tool like dynamic consent if it is to be used in a meaningful way also by people with dementia and their (informal) carers. We report findings from interviews and an expert focus group with people with dementia, their caretakers, and experts to depict their views and requirements on a tool like dynamic consent.

Eligibility criteria: Inclusion Criteria:

* no diagnosed cognitive impairment but first-degree relative with AD
* 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

Primary outcomes:
measure: Qualitative data: interpretations / opinions / needs / thoughts / feelings with regard to clinical data usage and dynamic consent.
timeFrame: 1-2 months. During the focus groups and interviews, answers given by participants will be audiorecorded and later transcribed to be thematically analysed.
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel (UZB)
state: Brussel
Study officials:
affiliation: VUB (Vrije Universiteit Brussel)
name: Lawrence Van den Bogaert, Master's
role: PRINCIPAL_INVESTIGATOR
References: