SchizophreniaNCT02665611
Remote Monitoring and Support for Patients With Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence
A study testing intervention for improvement of adherence and treatment as usual in people with Schizophrenia and Schizoaffective Disorder, run by Assuta Hospital Systems.
Trial summary
Moma call center will provide unique service -Remote monitoring and support for mental health patients .The aim of this reserch is reducing hospitalization and improve adherence, by reaching out and there for monitoring very closely . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- intervention for improvement of adherence and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jan 2018
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men \& women,
- age 18-60 ,
- "Maccabi Health service" patients with diagnosis of: schizophrenia, Schizo - effective or Bipolar Dis.
- Must have 30 days or more of hospitalization (during 3 years). Treated with psychiatric medication.
- Living independently or with a help of a caregiver.
- Is able to provide written informed consent.
Who cannot join
- Violent, or suicidal.
- Drug\ Alcohol, addiction,
- End stage Disease (Cancer, ESRF act.)
- Non - in depended and without Care giver/legal guardian
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Remote Monitoring and Support for Patients Suffering From Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence to Treatment
Moma call center will provide unique service -Remote monitoring and support for mental health patients .The aim of this reserch is reducing hospitalization and improve adherence, by reaching out and there for monitoring very closely .
Read the detailed description
"Moma" call center is a result of collaboration between Maccabi Health Services and The Gertner Institute of Epidemiology and Health Policy Research. The call center provides remote continuous monitoring and support for patients with chronic illnesses, and has been found useful for improvement in treatment adherence and other clinical measures in patients with diabetes and CHF.
The current project focuses on patients diagnosed with schizophrenia, schizoaffective disorder and bipolar disorder. Patients that suffer from these disorders are prone to low adherence and are at risk for discontinuation of treatment and frequent relapses.
The advantages of the "Moma" call-center include high availability, reaching out, collaboration between treatment centers and agents, and continuous remote monitoring. We hypothesize that these factors will enable improvement of support provided to these patients, early detection of their needs, connection with community care agents, monitoring of treatment adherence, and remote interventions targeted towards prevention of relapse.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Being tested
- intervention for improvement of adherence, treatment as usual
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention for improvement of adherenceBehavioural
intervention for improvement of adherence
treatment as usualBehavioural
The control group will be treated according to the usual stadard of care.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | intervention for improvement of treatment adherence "Intervention group"- This group will be followed by the "MOMA" call center (By the MOMA nures every couple weeks and by the study coordinatore and the treating Doctor at special "visits" as the study required.) The group will be monitored according to number of parameters, including treatment Adherence. Receives: Behavioral: intervention for improvement of adherence |
| control group | Experimental | treatment as usual Control group- Treatment will continue as usual by the Doctor.(This group will allso be followed by the Study Coordinator at the same "visits" as the "Intervention group".The group will be monitored according to number of parameters, including treatment Adherence. Receives: Behavioral: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days of hospitalization
Measured: through study competion ,an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Asaf B Caspi, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665611
- Sponsor's protocol ID
- 2124-15-SMC
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Monitoring and Support for Patients Suffering From Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence to Treatment
- ClinicalTrials.gov ID
- NCT02665611
- Acronym / sponsor ID
- 2124-15-SMC
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 28 Jan 2016 (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.
Moma call center will provide unique service -Remote monitoring and support for mental health patients .The aim of this reserch is reducing hospitalization and improve adherence, by reaching out and there for monitoring very closely .
Detailed description
"Moma" call center is a result of collaboration between Maccabi Health Services and The Gertner Institute of Epidemiology and Health Policy Research. The call center provides remote continuous monitoring and support for patients with chronic illnesses, and has been found useful for improvement in treatment adherence and other clinical measures in patients with diabetes and CHF.
The current project focuses on patients diagnosed with schizophrenia, schizoaffective disorder and bipolar disorder. Patients that suffer from these disorders are prone to low adherence and are at risk for discontinuation of treatment and frequent relapses.
The advantages of the "Moma" call-center include high availability, reaching out, collaboration between treatment centers and agents, and continuous remote monitoring. We hypothesize that these factors will enable improvement of support provided to these patients, early detection of their needs, connection with community care agents, monitoring of treatment adherence, and remote interventions targeted towards prevention of relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: intervention for improvement of adherenceintervention for improvement of treatment adherence "Intervention group"- This group will be followed by the "MOMA" call center (By the MOMA nures every couple weeks and by the study coordinatore and the treating Doctor at special "visits" as the study required.) The group will be monitored according to number of parameters, including treatment Adherence. |
| control group | Experimental | Behavioral: treatment as usualtreatment as usual Control group- Treatment will continue as usual by the Doctor.(This group will allso be followed by the Study Coordinator at the same "visits" as the "Intervention group".The group will be monitored according to number of parameters, including treatment Adherence. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men \& women,
- age 18-60 ,
- "Maccabi Health service" patients with diagnosis of: schizophrenia, Schizo - effective or Bipolar Dis.
- Must have 30 days or more of hospitalization (during 3 years). Treated with psychiatric medication.
- Living independently or with a help of a caregiver.
Key exclusion criteria (4 listed)
- Violent, or suicidal.
- Drug\ Alcohol, addiction,
- End stage Disease (Cancer, ESRF act.)
- Non - in depended and without Care giver/legal guardian
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 |
|---|---|---|
| intervention for improvement of adherenceintervention for improvement of adherence | Behavioural | intervention group |
| treatment as usualThe control group will be treated according to the usual stadard of care. | Behavioural | control group |
Primary outcome
number of days of hospitalization
Time frame: through study competion ,an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Asaf B Caspi, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing intervention for improvement of adherence and treatment as usual in people with Schizophrenia and Schizoaffective Disorder, run by Assuta Hospital Systems.
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 6 inclusion and 4 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 9 Feb 2016. 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 Meytal L Kahlon, MA (+972-52-8568283 ext. 0, kahlon_me@mac.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days of hospitalization (time frame: through study competion ,an average of 1 year.). 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 9 Feb 2016.