Mental DisorderNCT04674059
A Descriptive Study on Patients With Bipolar Disorder in Rwanda
An observational study of Mental Disorder and Bipolar Disorder, run by University of Aarhus.
Trial summary
The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder, Bipolar Disorder
- What is being tested?
- patient survey
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Outpatients with bipolar disorder in Rwanda
Who may be able to join
- A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
- Age ≥ 18 years
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda
Read the 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.
- Conditions
- Mental Disorder, Bipolar Disorder
- Being tested
- patient survey
- Medical subject headings
- Mental Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient surveyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnoses
Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.
Measured: 1 year
Diagnostic delay
Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.
Measured: 1 year
Number of previous psychiatric hospitalisations
Numerical value of the previous psychiatric hospitalisations.
Measured: 1 year
Number of previous crises
Numerical value of the previous crises defined as an episode of depression or mania or hypomania.
Measured: 1 year
Types of medical treatment provided
What type of medical treatment is provided, including brand name, administration and dosage.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Sponsor
- Investigators
- Per Kallestrup, Prof., Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674059
- Sponsor's protocol ID
- AUUR2020DKRW_3
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study on Patients With Bipolar Disorder in Rwanda
- ClinicalTrials.gov ID
- NCT04674059
- Acronym / sponsor ID
- AUUR2020DKRW_3
- Conditions
- Mental Disorder, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Rwanda, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatients with bipolar disorder in Rwanda
Key inclusion criteria (2 listed)
- A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient surveyA 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. | Other | – |
Primary outcome
Diagnoses
Time frame: 1 year
Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.
Diagnostic delay
Time frame: 1 year
Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.
Number of previous psychiatric hospitalisations
Time frame: 1 year
Numerical value of the previous psychiatric hospitalisations.
Number of previous crises
Time frame: 1 year
Numerical value of the previous crises defined as an episode of depression or mania or hypomania.
Types of medical treatment provided
Time frame: 1 year
What type of medical treatment is provided, including brand name, administration and dosage.
Medical Adherence
Time frame: 1 year
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.
The referral pathways
Time frame: 1 year
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.
Degree of internal stigma
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Kallestrup, Prof. study chair
University of Aarhus
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder and Bipolar Disorder, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline J Arnbjerg, Msc (+250786917224, caroline.arnbjerg@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnoses (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.