Functional PsychosesNCT00670371
Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study
An observational study of Functional Psychoses and Informal Caregivers, run by AstraZeneca at 9 sites in Sweden.
Trial summary
The objective is to find determinants for the subjective and objective burden of informal caregivers to patients who are requiring continued antipsychotic treatment for functional psychoses among factors related to the patient, the health care and support provision system and the informal caregiver him/her-self. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Psychoses, Informal Caregivers
- How many people
- 100 participants
- Where
- 9 sitesSweden
- Study dates
- Mar 2008to Nov 2009
- 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: Psychiatric patients and informal caregivers. Selected from outpatient wards
Who may be able to join
- Provision of informed consent
- Patients, male or female, aged 18 years or more, suffering or having suffered from a psychotic episode and being in need of continuous antipsychotic medication.
- The respective patient must have at least one informal caregiver.
- Subjects (patients and informal caregivers) must be able to read and write.
Who cannot join
- Diagnosis of dementia and such cognitive impairment which makes self assessments even with assistance unreliable (patients and informal caregivers).
- Involvement in the planning and conduct of the study (patients and informal caregivers).
- Other concurrent medical condition interfering with ability to complete study (patients and informal caregivers).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Sweden9 sites
Research site
Bromma
Research Site
Danderyd
Research Site
Falköping
Research Site
Huddinge
Research Site
Lidingö
Research Site
Ljungby
Research Site
Malmö
Research Site
Solna
Research Site
Stockholm
About this study
The objective is to find determinants for the subjective and objective burden of informal caregivers to patients who are requiring continued antipsychotic treatment for functional psychoses among factors related to the patient, the health care and support provision system and the informal caregiver him/her-self.
Read the detailed description
The study also comprises a descriptive part with the aim:
- To describe clinical characteristics, symptoms, and functioning in the patient group.
- To describe patient resource use in terms of support from the health care and social care sector.
- To describe the socio-economic situation, the general and psychological health, and the coping ability of the informal caregivers.
- Conditions
- Functional Psychoses, Informal Caregivers
- Keywords
- Caregiver burden
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients having the following diagnoses are eligible for inclusion into the study: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, delusional disorder, affective psychosis with mood incongruent delusions, psychotic disorder not otherwise specified or patients being actively psychotic. | |
| 2 | Closest relative(s) /informal caregiver(s) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startMar 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional PsychosesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva Dencker Vansvik, Study director, AstraZeneca, MC, SwedenLena Flyckt, Principal investigator, Danderyds Hospital, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670371
- Sponsor's protocol ID
- NIS-NSE-DUM-2007/1
- Status last verified
- Nov 2009
- First submitted
- 29 Apr 2008
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study
- ClinicalTrials.gov ID
- NCT00670371
- Acronym / sponsor ID
- NIS-NSE-DUM-2007/1
- Conditions
- Functional Psychoses, Informal Caregivers
- Keywords
- Caregiver burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Study completion
- Nov 2009 (actual)
- First posted
- 1 May 2008 (estimated)
- 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 objective is to find determinants for the subjective and objective burden of informal caregivers to patients who are requiring continued antipsychotic treatment for functional psychoses among factors related to the patient, the health care and support provision system and the informal caregiver him/her-self.
Detailed description
The study also comprises a descriptive part with the aim:
- To describe clinical characteristics, symptoms, and functioning in the patient group.
- To describe patient resource use in terms of support from the health care and social care sector.
- To describe the socio-economic situation, the general and psychological health, and the coping ability of the informal caregivers.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients having the following diagnoses are eligible for inclusion into the study: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, delusional disorder, affective psychosis with mood incongruent delusions, psychotic disorder not otherwise specified or patients being actively psychotic. |
| 2 | – | –Closest relative(s) /informal caregiver(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric patients and informal caregivers. Selected from outpatient wards
Key inclusion criteria (4 listed)
- Provision of informed consent
- Patients, male or female, aged 18 years or more, suffering or having suffered from a psychotic episode and being in need of continuous antipsychotic medication.
- The respective patient must have at least one informal caregiver.
- Subjects (patients and informal caregivers) must be able to read and write.
Key exclusion criteria (3 listed)
- Diagnosis of dementia and such cognitive impairment which makes self assessments even with assistance unreliable (patients and informal caregivers).
- Involvement in the planning and conduct of the study (patients and informal caregivers).
- Other concurrent medical condition interfering with ability to complete study (patients and informal caregivers).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
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Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
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Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
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RecruitingObservational study
Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia
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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.
Eva Dencker Vansvik study director
AstraZeneca, MC, Sweden
Lena Flyckt principal investigator
Danderyds Hospital, Stockholm
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Psychoses and Informal Caregivers, run by AstraZeneca at 9 sites in Sweden.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 25 Nov 2009.