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

Primary Purpose

Schizophrenia, Medication Nonadherence, Schizo Affective Disorder

Status
Completed
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
Customized Adherence Enhancement
Haloperidol Decanoate
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring nonadherence, Schizophrenia, Africa, Schizoaffective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MUHAS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAE + LAI

Arm Description

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

Outcomes

Primary Outcome Measures

Tablets Routine Questionnaire (TRQ)
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).
Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:
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

Drug Attitude Inventory (DAI)
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.
Brief Psychiatric Rating Scale (BPRS)
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.
Clinical Global Impressions (CGI)
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Social and Occupational Functioning Scale (SOFAS)
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.
Body Mass Index
Body Mass Index kg/m^2 of participants
ESRS-A Parkinsonism
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.
ESRS-A Dystonia
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.
ESRS-A Dyskinesia
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.
ESRS-A Akathisia
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.

Full Information

First Posted
March 27, 2020
Last Updated
September 15, 2021
Sponsor
Case Western Reserve University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04327843
Brief Title
Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)
Acronym
CAPACITY
Official Title
Reducing the Burden of Chronic Psychotic Disorders in Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Medication Nonadherence, Schizo Affective Disorder
Keywords
nonadherence, Schizophrenia, Africa, Schizoaffective

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAE + LAI
Arm Type
Experimental
Arm Description
Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)
Intervention Type
Behavioral
Intervention Name(s)
Customized Adherence Enhancement
Other Intervention Name(s)
CAE
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Haloperidol Decanoate
Other Intervention Name(s)
Haldol Decanoate
Intervention Description
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.
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
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
Title
Body Mass Index
Description
Body Mass Index kg/m^2 of participants
Time Frame
Baseline to Month 6(week 25)
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)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUHAS
City
Dar Es Salaam
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35086504
Citation
Mbwambo J, Kaaya S, Lema I, Burant CJ, Magwiza C, Madundo K, Njiro G, Blixen CE, Cassidy KA, Levin JB, Sajatovic M. An interventional pilot of customized adherence enhancement combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania. BMC Psychiatry. 2022 Jan 27;22(1):62. doi: 10.1186/s12888-022-03695-8.
Results Reference
derived

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

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