Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)

• Sponsor: Case Western Reserve University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04327843
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Medication Nonadherence; Schizo Affective Disorder	Behavioral: Customized Adherence Enhancement; Drug: Haloperidol Decanoate	Phase 3

Detailed Description

In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa.

The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reducing the Burden of Chronic Psychotic Disorders in Tanzania
• Actual Study Start Date: Nov 5, 2019
• Actual Primary Completion Date: Jul 30, 2020
• Actual Study Completion Date: Jul 30, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: CAE + LAI Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)

Behavioral: Customized Adherence Enhancement; Customized Adherence Enhancement (CAE): CAE targets key areas relevant to adherence in chronic psychotic disorders (CPD): 1.) inadequate understanding of mental disorder, 2.) lack of adequate medication-taking routines, 3.) poor communication with care providers and 4.) substance use which interferes with adherence and recovery. CAE delivered components are selected based upon findings from the ROMI and AMSQ. CAE will be delivered in approximately 8 sessions by a nurse interventionist, ideally at the same time that the long-acting injectable (LAI) is administered.The intervention is guided by a detailed manual and uses components and resources that are available in lower- and middle-income countries (LMICs). Social worker interventionists will be trained to deliver CAE-L.; Other Names: CAE ; Drug: Haloperidol Decanoate; Long-acting injectable (LAI): Patients on oral haloperidol will be switched to haloperidol decanoate per manufacturer's package insert. Individuals not on antipsychotic medication at the time of screening assessment or who are on a different antipsychotic medication, will receive an oral tolerance test (OTT) consisting of up to 14 days of oral haloperidol 2-5 mg once or twice daily. If the OTT suggests good tolerability, the participant will then receive LAI (haloperidol decanoate) intramuscularly after completion of baseline assessments. Dosing of LAI will be as clinically indicated using conservative dosing to minimize drug-related adverse effects. In the CWRU studies, mean end-point dose of haloperidol decanoate was 68.0 mg, SD 21.1, Range 50-100 mg/monthly injection. It is anticipated that patients will continue on the same dose for 6 months, although dose changes will be permitted based upon clinical status. Each study participant will receive up to 8 injections during the study.; Other Names: Haldol Decanoate

Outcome Measures

Primary Outcome Measures

1. Tablets Routine Questionnaire (TRQ) [Change from Baseline to 6 month visit]

   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).

2. Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections: [Baseline to 6 month visit]

   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).

Secondary Outcome Measures

1. Drug Attitude Inventory (DAI) [Baseline to 6 month visit]

   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.

2. Brief Psychiatric Rating Scale (BPRS) [Baseline to 6 month visit]

   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.

3. Clinical Global Impressions (CGI) [Baseline to 6 month visit]

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

4. Social and Occupational Functioning Scale (SOFAS) [Baseline to 6 month visit]

   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.

5. Body Mass Index [Baseline to Month 6(week 25)]

   Body Mass Index kg/m^2 of participants

6. ESRS-A Parkinsonism [Baseline to 6 months(25 weeks)]

   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.

7. ESRS-A Dystonia [Baseline to 6 months(25 weeks)]

   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.

8. ESRS-A Dyskinesia [Baseline to 6 months(25 weeks)]

   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.

9. ESRS-A Akathisia [Baseline to 6 months(25 weeks)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 and older

• Diagnosis of schizophrenia or schizoaffective disorder

• Known to have medication treatment adherence problems as identified by the TRQ (20% or more missed medications in past week or past month)

• Ability to be rated on psychiatric rating scales

• Willingness to take long-acting injectable medication

• Able to provide written, informed consent to study participation

Exclusion Criteria:

• History of allergy or intolerance to haloperidol or haloperidol decanoate

• Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MUHAS	Dar Es Salaam		Tanzania

Sponsors and Collaborators

• Case Western Reserve University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Martha Sajatovic, MD, Case Western Reserve University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 7, 2019
• Informed Consent Form: Survey ICF UH stamped - Apr 7, 2020
• Informed Consent Form: English Qualitative Interview - Apr 7, 2020
• Informed Consent Form: Focus Group ICF - Apr 7, 2020
• Informed Consent Form: Phase 3 ICF - Apr 7, 2020

More Information

Publications

None provided.

• Responsible Party: Martha Sajatovic, MD, Professor of Psychiatry and of Neurology, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT04327843
• Other Study ID Numbers: 1-17-19; R21MH114700
• First Posted: Mar 31, 2020
• Last Update Posted: Oct 12, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Martha Sajatovic, MD, Professor of Psychiatry and of Neurology, Case Western Reserve University: nonadherence; Schizophrenia; Africa; Schizoaffective
• Additional relevant MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Mood Disorders; Haloperidol; Haloperidol decanoate

Study Results

Participant Flow

Recruitment Details

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.

Pre-assignment Detail

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.

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Period Title: Baseline Assessment
STARTED	19
COMPLETED	19
NOT COMPLETED	0
Period Title: Baseline Assessment
STARTED	19
COMPLETED	19
NOT COMPLETED	0
Period Title: Baseline Assessment
STARTED	19
COMPLETED	18
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.79 (9.31)
Sex: Female, Male (Count of Participants)
Female	5 26.3%
Male	14 73.7%
Race and Ethnicity Not Collected (Count of Participants)
Marital status (Count of Participants)
Single/never married	12 63.2%
Married	2 10.5%
Separated/divorced	4 21.1%
Widowed	1 5.3%
Educational level (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.37 (2.99)
Employment (Count of Participants)
Full-time	4 21.1%
Part-time	3 15.8%
Unemployed	12 63.2%
Age of CPD(chronic psychotic disorder) onset (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.89 (4.47)
Duration of CPD(chronic psychotic disorder) (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.89 (10.87)
Number of previous hospitalizations (hospitalizations) [Mean (Standard Deviation) ]
For CPD(chronic psychotic disorders)	6.16 (7.55)
For substance abuse	0.05 (0.23)
Past physical abuse (Count of Participants)
Count of Participants [Participants]	6 31.6%
Past sexual abuse (Count of Participants)
Count of Participants [Participants]	1 5.3%
Family history of mental illness (Count of Participants)
Count of Participants [Participants]	10 52.6%
Family history of substance abuse (Count of Participants)
Count of Participants [Participants]	10 52.6%
AUDIT score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.84 (3.13)
ASSIST score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.58 (2.65)
Self-reported Charlson Index score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.37 (0.50)
Body Mass Index(BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	22.70 (4.89)
Past oral medication history (Count of Participants)
Chlorpromazine	8 42.1%
Fluphenizine	11 57.9%
Haloperidol	14 73.7%
Olanzapine	3 15.8%
Promethazine	8 42.1%
Risperidone	5 26.3%
Screening TRQ(tablets routine questionnaire) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	21.84 (13.83)
Baseline TRQ(tablets routine questionnaire) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	12.94 (11.93)

Outcome Measures

1. Primary Outcome

Title	Tablets Routine Questionnaire (TRQ)
Description	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).
Time Frame	Change from Baseline to 6 month visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	2
TRQ Week adherence	-57 (60.8)
TRQ Month adherence	-23 (0)

2. Primary Outcome

Title	Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:
Description	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).
Time Frame	Baseline to 6 month visit

Outcome Measure Data

Analysis Population Description

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%.

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Count of Participants [Participants]	18 94.7%

3. Secondary Outcome

Title	Drug Attitude Inventory (DAI)
Description	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.
Time Frame	Baseline to 6 month visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	7.89 (2.72)
25 Weeks	9.83 (0.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	0.001
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed

4. Secondary Outcome

Title	Brief Psychiatric Rating Scale (BPRS)
Description	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.
Time Frame	Baseline to 6 month visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	27.00 (10.26)
25-Weeks	25.06 (8.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	0.43
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed.

5. Secondary Outcome

Title	Clinical Global Impressions (CGI)
Description	The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Time Frame	Baseline to 6 month visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	17
Baseline	2.88 (1.32)
25 Weeks	2.24 (1.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	0.07
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed.

6. Secondary Outcome

Title	Social and Occupational Functioning Scale (SOFAS)
Description	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.
Time Frame	Baseline to 6 month visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	62.17 (18.28)
25 Weeks	68.39 (15.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	0.10
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed.

7. Secondary Outcome

Title	Body Mass Index
Description	Body Mass Index kg/m^2 of participants
Time Frame	Baseline to Month 6(week 25)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	22.79 (5.02)
25 Weeks	22.92 (5.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	0.75
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed.

8. Secondary Outcome

Title	ESRS-A Parkinsonism
Description	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.
Time Frame	Baseline to 6 months(25 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	0.06 (0.24)
25 Weeks	0.06 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	1.00
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed.

9. Secondary Outcome

Title	ESRS-A Dystonia
Description	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.
Time Frame	Baseline to 6 months(25 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	0.00 (0.00)
Week 25	0.00 (0.00)

10. Secondary Outcome

Title	ESRS-A Dyskinesia
Description	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.
Time Frame	Baseline to 6 months(25 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	0.17 (0.51)
Week 25	0.11 (0.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	0.75
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed.

11. Secondary Outcome

Title	ESRS-A Akathisia
Description	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.
Time Frame	Baseline to 6 months(25 weeks)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
Measure Participants	18
Baseline	0.28 (0.75)
Week 25	0.00 (0.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE + LAI Treatment
	Comments
	Type of Statistical Test	Other
	Comments	This is a prospective study with a repeated measures design.
Statistical Test of Hypothesis	p-Value	0.14
	Comments	The threshold for statistical significance was p<0.05.
	Method	t-test, 2 sided
	Comments	It was dependent sample pairwise t-tests, two tailed.

Adverse Events

Time Frame	25 weeks
Arm/Group Title	CAE + LAI Treatment
Arm/Group Description	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).
All Cause Mortality
	CAE + LAI Treatment
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	CAE + LAI Treatment
	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)
Injury, poisoning and procedural complications
Substance use relapse and hospitalization	1/19 (5.3%)
Other (Not Including Serious) Adverse Events
	CAE + LAI Treatment
	Affected / at Risk (%)	# Events
Total	13/19 (68.4%)
Eye disorders
Blurry vision	3/19 (15.8%)
General disorders
Drowsiness	6/19 (31.6%)
Restlessness	2/19 (10.5%)
Musculoskeletal and connective tissue disorders
Muscle pain	2/19 (10.5%)
Nervous system disorders
Tremor	7/19 (36.8%)

Limitations/Caveats

The small sample size, single-site enrollment, and the fact that poor medication adherence was one of the inclusion criterion may make findings less generalizable to the full spectrum of patients with CPD in Tanzania. Additionally, since we did not collect data on family burden, it is not possible to make any conclusions regarding how CAE-L may impact families and communities.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.