Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04988360
Eligibility Criteria:
PwD inclusion criteria:
* Individuals who are 65 years of age or older.
* Individuals living at home with a family caregiver.
* Individuals diagnosed with mild to moderate dementia.
PwD exclusion criteria:
* Individuals with open wounds on face (sutured lacerations exempted).
* Individuals with a history of seizures or epilepsy.
* Individuals with a pacemaker.
* Individuals with head trauma or stroke leading to their current admission.
* Individuals with cervical conditions or injuries that would make it unsafe for them to use the VR headset.
* Individuals with alcohol related dementia/ Korsakoff syndrome.
* Individuals who have a Public Guardian and Trustee (PGT) as Substitute Decision Maker (SDM).
* Individuals who cannot speak and understand English
Caregiver inclusion criteria:
* Live with a PwD
* Identify as a primary caregiver for the PwD
Caregiver exclusion criteria:
* Individuals who cannot speak and understand English
* Individuals who are professional/formal caregivers for the PwD
* Individuals who are cognitively unable to provide informed consent for themselves
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04988360
Study Brief:
Protocol Section:
NCT04988360