A Descriptive Study on Patients With Bipolar Disorder in Rwanda

The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder; Mental Disorder
• Intervention / Treatment: Other: patient survey

Detailed Description

The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda for patients with bipolar disorder.

Knowing about the barriers to treatment, risk and protective factors as well as the current treatment offered for patients with bipolar disorder is essential for the development of therapeutic approaches and improvement in access to care. Up to now, no data on characteristics of patients with bipolar disorder in Rwanda and related risk and protective factors is available. For this purpose, all outpatients with bipolar disorder in Rwanda age > 18 years, will over a 1-year period be invited to participate in a survey on their experience living with bipolar disorder in Rwanda. Moreover, patients and relatives will be invited for in-depth interviews to explore their perceptions and experiences with the mental health system. Health care providers will meet for focus discussions on to assess the experience, knowledge and practice of caregiving for individuals with bipolar disorder.

• Study Type: Observational
• Enrollment (Anticipated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Outpatients with bipolar disorder in Rwanda

Description

Inclusion Criteria:

• A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
• Age ≥ 18 years

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnoses	Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.	1 year
Diagnostic delay	Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.	1 year
Number of previous psychiatric hospitalisations	Numerical value of the previous psychiatric hospitalisations.	1 year
Number of previous crises	Numerical value of the previous crises defined as an episode of depression or mania or hypomania.	1 year
Types of medical treatment provided	What type of medical treatment is provided, including brand name, administration and dosage.	1 year
Medical Adherence	Medication Adherence Rating Scale (MARS) will be used to assess beliefs and barriers to medication adherence. Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.	1 year
The referral pathways	Who initiated the first contact, who did you seek for help, what kind of help was provided, percent of patients who came in contact with traditional leaders.	1 year
Degree of internal stigma	Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) will be used to assess self-stigma. The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma.	1 year

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University of Rwanda; Mental Health Centre Copenhagen

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Bipolar and Related Disorders; Disease; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: AUUR2020DKRW_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No