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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04674059
Other study ID # AUUR2020DKRW_3
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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