Remote support for individuals with schizophrenia who struggle with medication adherence
Prospective 12-week Randomized Controlled Trial (RCT) of Remotely- Delivered Customized Adherence Enhancement for Poorly Adherent Individuals With Schizophrenia (CAE-S) vs Enhanced Treatment as Usual (eTAU)
NA · University Hospitals Cleveland Medical Center · NCT06061952
This study is testing a new remote support program to help people with schizophrenia stick to their medication and see if it improves their symptoms and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06061952 on ClinicalTrials.gov |
What this trial studies
This project evaluates the feasibility and effectiveness of a remotely delivered intervention called Customized Adherence Enhancement for Schizophrenia (CAE-S) for patients with schizophrenia. Participants will be randomly assigned to receive either CAE-S or Enhanced Treatment as Usual (eTAU) after a baseline assessment. The study will measure attendance, patient satisfaction, and changes in schizophrenia symptoms over 12 weeks using standardized scales. Additionally, it will explore the impact of the intervention on medication adherence and other secondary outcomes such as quality of life and functional status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with schizophrenia who have documented issues with medication adherence.
Not a fit: Patients currently receiving clozapine treatment may not benefit from this study due to the specific monitoring requirements associated with that medication.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence and overall health outcomes for patients with schizophrenia.
How similar studies have performed: Other studies have shown promise in using remote interventions to improve medication adherence in psychiatric populations, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI) * Prescribed an antipsychotic medication for treatment of schizophrenia * Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month) * Ability to be rated on psychiatric rating scales * Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation * Able to provide written, informed consent to study participation * Has access to electronic device and internet to complete sessions conducted on videoconferencing platform Exclusion Criteria: * Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence) * Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial * Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist * Immediate risk of harm to self or others * Female who is currently pregnant or breastfeeding
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Martha Sajatovic, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Gracie Howard-Griggs
- Email: Gracie.HowardGriggs@UHhospitals.org
- Phone: 888-819-0004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia