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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT04526067
Eligibility Criteria:
Inclusion Criteria:
1. Able to give informed consent.
2. Between the ages of 18 and 65.
3. Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder
4. Receiving treatment with oral psychiatric medications.
5. Have had a hospitalization or emergency department visit in the past year
6. Have a Medication Possession Ratio (MPR) based upon electronic refill data below 80% at least 1 of the past 4 quarters with at least 1 psychiatric medication
7. Responsible for taking their own medications
8. Report on telephone prescreen call with researcher team that they have missed at least 2 doses of medication in the past 3 weeks, that they are willing to take medication and would like remote assistance to take medication more regularly
9. Report on telephone prescreen call with research team that they have a stable living environment (individual apartment, family home, board and care facility) within the last three months and no plans to move in the next year
10. Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months
11. Have a working smart phone
12. Able to understand and complete rating scales and assessments.
13. Agree to home visits for intervention and to count pills and conduct assessments
Exclusion Criteria:
1. Substance dependence within the past 2 months
2. Currently being treated by an ACT team
3. Documented history of violence or threatening behavior on initial assessment
4. Receive home visits to assist with medication adherence
5. Unable to complete baseline assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04526067
Study Brief:
Protocol Section:
NCT04526067