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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT02440594
Eligibility Criteria:
Inclusion Criteria:
1. To be eligible for the Enhanced BHL Program, the only inclusion criterion is to have participated in an initial telephone assessment as part of the current PACE/PACENET BHL Clinical Program.
2. Similarly, to be eligible for the BHL Program Evaluations (i.e., BHL Clinical Data Evaluation, 3/6 Month Outcome Evaluation), the inclusion criterion is to have participated in an initial telephone assessment as part of the current PACE/PACENET BHL Clinical Program.
3. Enrollment in the current PACE/PACENET BHL Clinical Program. Though not part of the research program, the current program targets older, community-dwelling adults (i.e., 65 years and older) enrolled in the PACE/PACENET programs, who have filled at least one new prescription for an antidepressant, antipsychotic, and/or anxiolytic medication. The BHL program does require the basic ability to communicate by telephone; either the enrollee or an identified caregiver must meet this criterion for participation in the BHL Clinical Program.
Exclusion Criteria:
Exclusion criteria for participation in the Enhanced BHL Program and the 3/6 Month Outcome Evaluation are:
1. having severe cognitive impairment (BOMC score 14 or greater) in the absence of a caregiver, and/or
2. endorsement of psychosis or mania during the initial clinical interview, and/or
3. a PHQ score of 25 or greater, and/or
4. positive drug abuse screen, and/or
5. alcohol dependence.
Enrollees endorsing any of above mentioned exclusions will be offered assistance with referral to community specialty-care resources as part of the PACE/PACENET BHL Clinical Program.
Exclusion criteria for caregiver participation in the TEP component of Enhanced Care is lack of report of cognitive impairment when only the Caregiver interview was completed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02440594
Study Brief:
Protocol Section:
NCT02440594