Trial Outcomes & Findings for Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY) (NCT NCT04327843)

NCT ID: NCT04327843

Last Updated: 2021-10-12

Results Overview

The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 20-30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: Change from Baseline to 6 month visit
• Results posted on: 2021-10-12

Participant Flow

The study setting was Muhimbili National Hospital, a 70-bed national referral hospital located in urban Dar es Salaam, Tanzania. Patients were referred from 4 catchment zones that include 3 regional public and private hospitals and were recruited from inpatient and outpatient settings. 19 adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication demonstrating poor adherence.

38 individuals were assessed for preliminary eligibility. 16 people were excluded, 5 were unable to contact, 2 were not interested, 3 did not meet criteria, and 6 were no-shows for screening. 22 provided informed consent initially. 2 of these people failed the oral tolerance test and 1 did not complete baseline measures. 19 participants enrolled and attended visits 1-6 and 18 attended all 7 visits.

Participant milestones

Measure	CAE + LAI Treatment The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Baseline Assessment STARTED	19
Baseline Assessment COMPLETED	19
Baseline Assessment NOT COMPLETED	0
Week 13 Assessment STARTED	19
Week 13 Assessment COMPLETED	19
Week 13 Assessment NOT COMPLETED	0
Week 25 Assessment STARTED	19
Week 25 Assessment COMPLETED	18
Week 25 Assessment NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CAE + LAI Treatment n=19 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Age, Continuous	38.79 years STANDARD_DEVIATION 9.31 • n=19 Participants
Sex: Female, Male Female	5 Participants n=19 Participants
Sex: Female, Male Male	14 Participants n=19 Participants
Marital status Single/never married	12 Participants n=19 Participants
Marital status Married	2 Participants n=19 Participants
Marital status Separated/divorced	4 Participants n=19 Participants
Marital status Widowed	1 Participants n=19 Participants
Educational level	8.37 years STANDARD_DEVIATION 2.99 • n=19 Participants
Employment Full-time	4 Participants n=19 Participants
Employment Part-time	3 Participants n=19 Participants
Employment Unemployed	12 Participants n=19 Participants
Age of CPD(chronic psychotic disorder) onset	19.89 years STANDARD_DEVIATION 4.47 • n=19 Participants
Duration of CPD(chronic psychotic disorder)	18.89 years STANDARD_DEVIATION 10.87 • n=19 Participants
Number of previous hospitalizations For CPD(chronic psychotic disorders)	6.16 hospitalizations STANDARD_DEVIATION 7.55 • n=19 Participants
Number of previous hospitalizations For substance abuse	0.05 hospitalizations STANDARD_DEVIATION 0.23 • n=19 Participants
Past physical abuse	6 Participants n=19 Participants
Past sexual abuse	1 Participants n=19 Participants
Family history of mental illness	10 Participants n=19 Participants
Family history of substance abuse	10 Participants n=19 Participants
AUDIT score	1.84 units on a scale STANDARD_DEVIATION 3.13 • n=19 Participants
ASSIST score	1.58 units on a scale STANDARD_DEVIATION 2.65 • n=19 Participants
Self-reported Charlson Index score	0.37 units on a scale STANDARD_DEVIATION 0.50 • n=19 Participants
Body Mass Index(BMI)	22.70 kg/m^2 STANDARD_DEVIATION 4.89 • n=19 Participants
Past oral medication history Chlorpromazine	8 Participants n=19 Participants
Past oral medication history Fluphenizine	11 Participants n=19 Participants
Past oral medication history Haloperidol	14 Participants n=19 Participants
Past oral medication history Olanzapine	3 Participants n=19 Participants
Past oral medication history Promethazine	8 Participants n=19 Participants
Past oral medication history Risperidone	5 Participants n=19 Participants
Screening TRQ(tablets routine questionnaire)	21.84 units on a scale STANDARD_DEVIATION 13.83 • n=19 Participants
Baseline TRQ(tablets routine questionnaire)	12.94 units on a scale STANDARD_DEVIATION 11.93 • n=18 Participants • 18 people were sampled instead of 19 in the baseline.

PRIMARY outcome

Timeframe: Change from Baseline to 6 month visit

Population: Since participants stopped using oral medications once they were stable on LAI, there were only two participants remaining at 25 Week visit and therefore analysis was not done. As only 2 individuals were on concommittent oral CPD medication at 25 week follow up, mean change in TRQ was not calculated. This was just done to enter into clinical trials.

The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 20-30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).

Outcome measures

Measure	CAE + LAI Treatment n=2 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Tablets Routine Questionnaire (TRQ) TRQ Week adherence	-57 percentage of change in adherence Standard Deviation 60.8
Tablets Routine Questionnaire (TRQ) TRQ Month adherence	-23 percentage of change in adherence Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline to 6 month visit

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). LAI injection frequency was 100%.

LAI injection adherence will be determined as a count of participants who received LAI injections at the appropriate time (within 7 days of scheduled time).

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:	18 Participants

SECONDARY outcome

Timeframe: Baseline to 6 month visit

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

DAI-10 scoring ranges from -10 to +10 with a total score >0 indicating a positive attitude toward psychiatric medications and a total score of <0 indicating a negative attitude toward psychiatric medications.

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Drug Attitude Inventory (DAI) Baseline	7.89 score on a scale Standard Deviation 2.72
Drug Attitude Inventory (DAI) 25 Weeks	9.83 score on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: Baseline to 6 month visit

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania.

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Brief Psychiatric Rating Scale (BPRS) Baseline	27.00 score on a scale Standard Deviation 10.26
Brief Psychiatric Rating Scale (BPRS) 25-Weeks	25.06 score on a scale Standard Deviation 8.53

SECONDARY outcome

Timeframe: Baseline to 6 month visit

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.

Outcome measures

Measure	CAE + LAI Treatment n=17 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Clinical Global Impressions (CGI) Baseline	2.88 units on a scale Standard Deviation 1.32
Clinical Global Impressions (CGI) 25 Weeks	2.24 units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline to 6 month visit

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning.

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Social and Occupational Functioning Scale (SOFAS) Baseline	62.17 score on a scale Standard Deviation 18.28
Social and Occupational Functioning Scale (SOFAS) 25 Weeks	68.39 score on a scale Standard Deviation 15.28

SECONDARY outcome

Timeframe: Baseline to Month 6(week 25)

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

Body Mass Index kg/m^2 of participants

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Body Mass Index Baseline	22.79 kg/m^2 Standard Deviation 5.02
Body Mass Index 25 Weeks	22.92 kg/m^2 Standard Deviation 5.58

SECONDARY outcome

Timeframe: Baseline to 6 months(25 weeks)

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

Extrapyramidal Symptoms Scale-Abbreviated version for Parkinsonism. It looks at drug-induced Parkinsonism which is made up of motor disturbances. Rigidity, tremor, reduced facial expression/speech, impaired gait/posture, postural instability, and bradykinesia. Each item is rated on a 4 point scale: 0=absent, 3=severe. The higher the value the more severe the Parkinsonism and worst outcomes.

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
ESRS-A Parkinsonism 25 Weeks	0.06 score on a scale Standard Deviation 0.24
ESRS-A Parkinsonism Baseline	0.06 score on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline to 6 months(25 weeks)

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

Extrapyramidal Symptoms Scale-Abbreviated version for dystonia- drug-induced dystonia is a muscle disorder in which movements are jerky or twisting. Due to the 0.00 values at baseline and 25 weeks, unable to perform t-test and get a p value so no statistical analysis section is reported for this Outcome Measure. Each item is rated on a 4 point scale: 0=absent, 3=severe with the higher numbers indicating worse dystonia and worse outcomes.

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
ESRS-A Dystonia Baseline	0.00 score on a scale Standard Deviation 0.00
ESRS-A Dystonia Week 25	0.00 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline to 6 months(25 weeks)

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

Extrapyramidal Symptoms Scale-Abbreviated version for Dyskinesia- drug-induced dyskinesia which is repetitive and involuntary movements. Each item is rated on a 4 point scale: 0=absent, 3=severe and higher values indicate greater severity of dyskinesia and worse outcomes.

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
ESRS-A Dyskinesia Baseline	0.17 score on a scale Standard Deviation 0.51
ESRS-A Dyskinesia Week 25	0.11 score on a scale Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline to 6 months(25 weeks)

Population: Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).

Extrapyramidal Symptoms Scale-Abbreviated version for akathisia- drug-induced akathisia consists of inner restlessness and urge to move. Items are measured on a 4 value scale: 0=absent, 3=severe, and higher values indicate more severe akathisia and worse outcomes.

Outcome measures

Measure	CAE + LAI Treatment n=18 Participants The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
ESRS-A Akathisia Baseline	0.28 score on a scale Standard Deviation 0.75
ESRS-A Akathisia Week 25	0.00 score on a scale Standard Deviation 0.00

Adverse Events

CAE + LAI Treatment

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	CAE + LAI Treatment n=19 participants at risk The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Injury, poisoning and procedural complications Substance use relapse and hospitalization	5.3% 1/19 • 25 weeks

Other adverse events

Measure	CAE + LAI Treatment n=19 participants at risk The sample comprised adult patients ≥ age 18 with schizophrenia who self-reported missing 20% or more of antipsychotic medication within the last month, an established benchmark for poor adherence who were given a long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L).
Nervous system disorders Tremor	36.8% 7/19 • 25 weeks
General disorders Drowsiness	31.6% 6/19 • 25 weeks
Eye disorders Blurry vision	15.8% 3/19 • 25 weeks
General disorders Restlessness	10.5% 2/19 • 25 weeks
Musculoskeletal and connective tissue disorders Muscle pain	10.5% 2/19 • 25 weeks

Additional Information

Kaylee Sarna

Case Western Reserve University

Phone: (216) 368-3577

Email: kns17@case.edu

Results disclosure agreements

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