A Descriptive Study on Patients With Bipolar Disorder in Rwanda

Bipolar Disorder Clinical Trial

Official title:

A Descriptive Study on Patients With Bipolar Disorder in Rwanda

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04674059
• Other study ID #: AUUR2020DKRW_3
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: University of Aarhus
• Contact: Caroline J Arnbjerg, Msc
• Phone: +250786917224
• Email: caroline.arnbjerg[@]ph.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Age = 18 years

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorder
• Mental Disorders

Intervention

Other:
• patient survey
A questionnaire will be delivered by the health care providers at Ndera Hospital, Kigali, Rwanda or CHUK, Hospital, Kigali, Rwanda. The questions will explore the patient's clinical characteristics, the current treatment and their experience with the mental health care system.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Mental Health Centre Copenhagen, University of Rwanda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnoses	Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.	1 year
Primary	Diagnostic delay	Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.	1 year
Primary	Number of previous psychiatric hospitalisations	Numerical value of the previous psychiatric hospitalisations.	1 year
Primary	Number of previous crises	Numerical value of the previous crises defined as an episode of depression or mania or hypomania.	1 year
Primary	Types of medical treatment provided	What type of medical treatment is provided, including brand name, administration and dosage.	1 year
Primary	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
Primary	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
Primary	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