Mental DisorderNCT04648982
Psychiatric Inpatient Discharge Data - Rwanda
An observational study of Mental Disorder, run by University of Aarhus at 2 sites in Rwanda.
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
- What is being tested?
- Admission to inpatient psychiatric unit
- How many people
- 1,000 participants
- Where
- 2 sitesRwanda
- Study dates
- 1 Feb 2020to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: Persons that are hospitalized due to mental health concerns in Rwanda.
Who may be able to join
- All patients discharged from the inpatient psychiatric unit at Ndera Hospital, Rwanda
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Rwanda2 sites, 2 recruiting
- Recruiting
Ndera Hospital
Huye
Emmanuel Musoni-Rwilliza, Msc, +250788568244, rwimus@gmail.com
Caroline J Arnbjerg, Msc, +250786917224, caroline.arnbjerg@ph.au.dk
- Recruiting
Ndera Hospital
Kigali
Emmanuel Musoni Rwililiza, Msc, +250788568244, rwimus@gmail.com
Caroline j Arnbjerg, Msc, +250786917224, caroline.arnbjerg@ph.au.dk
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
For a one-year period, descriptive data on all inpatients with age > 18 years, discharged from Ndera Hospital the only inpatient psychiatric hospital in Rwanda, will be collected from files. The descriptive data includes diagnosis, duration of hospitalization, medication, addiction, insurance, Somatic- and psychiatric comorbidity, referral pathways, employment status, number of previous hospitalizations. To the investigators' knowledge, there is no descriptive data on psychiatric inpatients in the country of Rwanda. Therefore, this. Information will be crucial for understanding the service provision at the referral hospitals and the accessibility to intensive mental health care in Rwanda. The data will be anonymized and recorded - this ensures the data cannot be linked to anyone subject which supplied it.
- Conditions
- Mental Disorder
- Being tested
- Admission to inpatient psychiatric unit
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Admission to inpatient psychiatric unitOther
All persons in the study are hospitalized at the only inpatient mental health hospital in Rwanda - Ndera. Data will be collected when the person is being discharged.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis
Data will be collected from files
Measured: 1 year
Psychiatric comorbidity
Data will be collected from files
Measured: 1 year
Somatic comorbidity
Data will be collected from files
Measured: 1 year
Alcohol or drug addiction
Data will be collected from files
Measured: 1 year
Medical drug provided during this hospitalisation
Data will be collected from files
Measured: 1 year
Who made the referral
Data will be collected from files
Measured: 1 year
Number of previous hospitalisations
Data will be collected from files
Measured: 1 year
Insurance
Data will be collected from files
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 posted2 Dec 2020
- Study start1 Feb 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 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
- Retrospective
- Enrolment
- 1,000 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
- NCT04648982
- Sponsor's protocol ID
- AUUR2020DKRW_2
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2020
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Inpatient Discharge Data - Rwanda
- ClinicalTrials.gov ID
- NCT04648982
- Acronym / sponsor ID
- AUUR2020DKRW_2
- Conditions
- Mental Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 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 Feb 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 2 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
For a one-year period, descriptive data on all inpatients with age > 18 years, discharged from Ndera Hospital the only inpatient psychiatric hospital in Rwanda, will be collected from files. The descriptive data includes diagnosis, duration of hospitalization, medication, addiction, insurance, Somatic- and psychiatric comorbidity, referral pathways, employment status, number of previous hospitalizations. To the investigators' knowledge, there is no descriptive data on psychiatric inpatients in the country of Rwanda. Therefore, this. Information will be crucial for understanding the service provision at the referral hospitals and the accessibility to intensive mental health care in Rwanda. The data will be anonymized and recorded - this ensures the data cannot be linked to anyone subject which supplied it.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons that are hospitalized due to mental health concerns in Rwanda.
Key inclusion criteria (1 listed)
- All patients discharged from the inpatient psychiatric unit at Ndera Hospital, Rwanda
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 |
|---|---|---|
| Admission to inpatient psychiatric unitAll persons in the study are hospitalized at the only inpatient mental health hospital in Rwanda - Ndera. Data will be collected when the person is being discharged. | Other | – |
Primary outcome
Diagnosis
Time frame: 1 year
Data will be collected from files
Psychiatric comorbidity
Time frame: 1 year
Data will be collected from files
Somatic comorbidity
Time frame: 1 year
Data will be collected from files
Alcohol or drug addiction
Time frame: 1 year
Data will be collected from files
Medical drug provided during this hospitalisation
Time frame: 1 year
Data will be collected from files
Who made the referral
Time frame: 1 year
Data will be collected from files
Number of previous hospitalisations
Time frame: 1 year
Data will be collected from files
Insurance
Time frame: 1 year
Data will be collected from files
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder, run by University of Aarhus at 2 sites in Rwanda.
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 1 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Diagnosis (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 8 Apr 2021.