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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT02347202
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for caregivers to become research participants include:
1. access to an Internet-connected computer with a camera, microphone, and speakers either at home, or at another location that affords privacy;
2. fluent in spoken and written English; and
3. caregivers who participate must be spouses or partners of people with dementia living with them at home when they enter the study. In addition, all caregivers must have at least one family member (or close friend) with whom they are in communication about the person with dementia, and/or their issues related to being a caregiver, who can participate in family counseling sessions; if not, they are excluded from the study.
Inclusion criteria for counselors to be research participants in both the pilot study and the RCT:
1. Certified or Master's level social worker, a nurse with an RN and at least two years' experience working with older adults and their family members evaluated on an individual basis by the PIs);
2. counselors who have received training online or in person in conducting the NYUCI and provided the intervention to at least one caregiver in person;
3. counselors who have completed the online training to conduct the NYUCI via videoconferencing;
4. counselors who have demonstrated the ability to contact caregivers and families via videoconferencing by interacting with HealthCare Interactive (HCI) staff in mock sessions (HCI is the technology developer for this Phase II effort); and
5. counselors who have confirmed they have personal liability and malpractice insurance.
Exclusion Criteria:
Exclusion criteria for caregivers to be participants are:
1. no access or severely limited access to an Internet-connected computer with a camera;
2. not fluent in spoken and written English;
3. not having a family member with whom they are in communication about the person with dementia; and
4. apparent severe mental or physical illness (e.g., self report of clinical depression).
Exclusion criteria for counselors include:
1. not a certified or Master's level social worker or nurse with an RN and at least two years' experience working with older adults and their family members, or other professional with at last two years' experience working with older adults and their family members (to be decided by the PIs);
2. counselors who have not received training online or in person in conducting the NYUCI;
3. counselors who have not completed the online training to conduct the NYUCI via videoconferencing;
4. counselors who cannot demonstrate ability to contact caregivers and families via videoconferencing by interacting with HCI; and
5. counselors who do not have personal liability and malpractice insurance.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
125 Years
Study:
NCT02347202
Study Brief:
Protocol Section:
NCT02347202