Alzheimer Disease, Early OnsetENGAGENCT05229978
Engagement 2.0 Forms of Consent for Data (re-)Use
An observational study of Alzheimer Disease, Early Onset and Mild Cognitive Impairment, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset, Mild Cognitive Impairment
- What is being tested?
- Showing an existing Dynamic Consent (computer interface) as prompt
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Aug 2022to 1 Feb 2023
- Phase
- Observational
- 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
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
Who may be able to join
- 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)
Who cannot join
- Patients with moderate to severe dementia due to AD, defined as MMSE total score 20/30 or lower
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel (UZB)
Jette, Brussels Capital, 1090
About this study
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.
Read the 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.
- Being tested
- Showing an existing Dynamic Consent (computer interface) as prompt
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Showing an existing Dynamic Consent (computer interface) as promptOther
An existing Dynamic Consent interface will be shown as a prompt halfway through the focus group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AD or mild cognitive impairment due to AD | All three 'arms' take part in a focus group or interview. 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 health data engagement interfaces (Dynamic Consent) may play in this. Receives: Other: Showing an existing Dynamic Consent (computer interface) as prompt | |
| Informal carers of patients with AD or mild cognitive impairment due to AD | All three 'arms' take part in a focus group or interview. 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 health data engagement interfaces (Dynamic Consent) may play in this. Receives: Other: Showing an existing Dynamic Consent (computer interface) as prompt | |
| Dementia experts/specialists | Given their expertise on dementia from a professional point of view, a focus group is conducted with dementia specialists in order to elicit their views and ideas on health data engagement interface like Dynamic Consent. Receives: Other: Showing an existing Dynamic Consent (computer interface) as prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data: interpretations / opinions / needs / thoughts / feelings with regard to clinical data usage and dynamic consent.
Collected in response to questions from an open-ended questionnaire (interview guide), the outcome of the focus groups and interviews will be rich qualitative data that will provide a better understanding of patients' assumed skills, capabilities and preferences necessary to meaningfully interact with health data engagement (dynamic consent) interfaces" for clinical data usage consent.
Measured: 1-2 months. During the focus groups and interviews, answers given by participants will be audiorecorded and later transcribed to be thematically analysed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start17 Aug 2022
- Primary completion22 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Van den Bogaert, Master's, Principal investigator, VUB (Vrije Universiteit Brussel)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229978
- Sponsor's protocol ID
- Engage 2.0
- Acronym
- ENGAGE
- Status last verified
- May 2022
- First submitted
- 7 Jan 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The qualitative data in this study (i.e. audio recordings from the focus groups and interviews) will be collected, stored and analysed only by the PI and the central contact backup.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement 2.0 Forms of Consent for Data (re-)Use
- ClinicalTrials.gov ID
- NCT05229978
- Acronym / sponsor ID
- ENGAGE / Engage 2.0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 8 Feb 2022 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with AD or mild cognitive impairment due to AD | – | Other: Showing an existing Dynamic Consent (computer interface) as promptAll three 'arms' take part in a focus group or interview. 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 health data engagement interfaces (Dynamic Consent) may play in this. |
| Informal carers of patients with AD or mild cognitive impairment due to AD | – | Other: Showing an existing Dynamic Consent (computer interface) as promptAll three 'arms' take part in a focus group or interview. 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 health data engagement interfaces (Dynamic Consent) may play in this. |
| Dementia experts/specialists | – | Other: Showing an existing Dynamic Consent (computer interface) as promptGiven their expertise on dementia from a professional point of view, a focus group is conducted with dementia specialists in order to elicit their views and ideas on health data engagement interface like Dynamic Consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients with moderate to severe dementia due to AD, defined as MMSE total score 20/30 or lower
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 |
|---|---|---|
| Showing an existing Dynamic Consent (computer interface) as promptAn existing Dynamic Consent interface will be shown as a prompt halfway through the focus group sessions. | Other | Dementia experts/specialists, Informal carers of patients with AD or mild cognitive impairment due to AD, Patients with AD or mild cognitive impairment due to AD |
Primary outcome
Qualitative data: interpretations / opinions / needs / thoughts / feelings with regard to clinical data usage and dynamic consent.
Time frame: 1-2 months. During the focus groups and interviews, 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 and interviews will be rich qualitative data that will provide a better understanding of patients' assumed skills, capabilities and preferences necessary to meaningfully interact with health data engagement (dynamic consent) interfaces" for clinical data usage consent.
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 21 Feb 2023.
- Individual participant dataSharing planned: No. The qualitative data in this study (i.e. audio recordings from the focus groups and interviews) will be collected, stored and analysed only by the PI and the central contact backup.
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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.
Lawrence Van den Bogaert, Master's principal investigator
VUB (Vrije Universiteit Brussel)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Early Onset and Mild Cognitive Impairment, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 inclusion and 1 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 21 Feb 2023. 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 Belgium. 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?
Qualitative data: interpretations / opinions / needs / thoughts / feelings with regard to clinical data usage and dynamic consent. (time frame: 1-2 months. During the focus groups and interviews, answers given by participants will be audiorecorded and later transcribed to be thematically analysed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.