- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04674059
A Descriptive Study on Patients With Bipolar Disorder in Rwanda
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
- Age ≥ 18 years
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnoses
Tidsram: 1 year
|
Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.
|
1 year
|
|
Diagnostic delay
Tidsram: 1 year
|
Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.
|
1 year
|
|
Number of previous psychiatric hospitalisations
Tidsram: 1 year
|
Numerical value of the previous psychiatric hospitalisations.
|
1 year
|
|
Number of previous crises
Tidsram: 1 year
|
Numerical value of the previous crises defined as an episode of depression or mania or hypomania.
|
1 year
|
|
Types of medical treatment provided
Tidsram: 1 year
|
What type of medical treatment is provided, including brand name, administration and dosage.
|
1 year
|
|
Medical Adherence
Tidsram: 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.
|
1 year
|
|
The referral pathways
Tidsram: 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.
|
1 year
|
|
Degree of internal stigma
Tidsram: 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.
|
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AUUR2020DKRW_3
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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