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

NCT ID: NCT04327843

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2020-07-30

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.

Conditions

Schizophrenia; Medication Nonadherence; Schizo Affective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAE + LAI

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

Group Type: EXPERIMENTAL

Customized Adherence Enhancement

Intervention Type: BEHAVIORAL

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.

Haloperidol Decanoate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

CAE; Haldol Decanoate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Martha Sajatovic, MD

Professor of Psychiatry and of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha Sajatovic, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

MUHAS

Dar es Salaam, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 35086504 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Survey ICF UH stamped

View Document

Document Type: Informed Consent Form: English Qualitative Interview

View Document

Document Type: Informed Consent Form: Focus Group ICF

View Document

Document Type: Informed Consent Form: Phase 3 ICF

View Document

Other Identifiers

R21MH114700

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1-17-19

Identifier Type: -

Identifier Source: org_study_id