Trial Outcomes & Findings for Patient-Centered Medication Adherence Intervention for Schizophrenia (NCT NCT00144027)

NCT ID: NCT00144027

Last Updated: 2015-04-24

Results Overview

The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 6-months
• Results posted on: 2015-04-24

Participant Flow

Participant milestones

Measure	Control The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.	Antipsychotic Adherence Intervention Group Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
Overall Study STARTED	39	36
Overall Study Completed Baseline Assessment	39	29
Overall Study Completed 6 Month Assessment	37	24
Overall Study COMPLETED	36	25
Overall Study NOT COMPLETED	3	11

Reasons for withdrawal

Measure	Control The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.	Antipsychotic Adherence Intervention Group Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
Overall Study Lost to Follow-up	1	3
Overall Study Withdrawal by Subject	2	2
Overall Study did not complete baseline assessment	0	6

Baseline Characteristics

Patient-Centered Medication Adherence Intervention for Schizophrenia

Baseline characteristics by cohort

Measure	Control/No Intervention n=39 Participants The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.	Intervention Group n=29 Participants Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.	Total n=68 Participants Total of all reporting groups
Age, Continuous	53.5 years STANDARD_DEVIATION 8.3 • n=5 Participants	52.9 years STANDARD_DEVIATION 5.6 • n=7 Participants	53.3 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	25 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-months

Population: Percent of participants who reported "never missed taking my medication" at 6-months

The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.

Outcome measures

Measure	Control/No Intervention n=37 Participants The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.	Intervention Group n=24 Participants Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
Antipsychotic Medication Adherence	63.9 percentage of participants	75.0 percentage of participants

Adverse Events

Control/No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeff Pyne

Central Arkansas Veterans Healthcare System

Phone: 501-257-1083

Email: jeffrey.pyne@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place