SchizophreniaNCT01729572
Measuring the Effect of Remote Monitoring of Treatment Adherence on the Risk of Re-admission of Ambulatory Schizophrenic Patients
A study testing Tele-medicine monitoring of medication adherence in people with Schizophrenia and Schizoaffective Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Tele-medicine monitoring of medication adherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Aug 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM 4 diagnosis of schizophrenia or schizoaffective
- able to give written informed consent
- Have a telephone line
Who cannot join
- Are not discharged to a place with routine medication monitoring
- Are not discharged under forced ambulatory treatment order
- Are not homeless
- Are not admitted due to drug intoxication or withdrawal.
- Are not admitted due to severe self harm.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shalvata MHC
Hod HaSharon, 45100
Israel Krieger, Dr' Med, +97297478665, israelkr@clalit.org.il
Israel Krieger, Dr' Med
About this study
Official title: The Effect of add-on Tele Medicine Monitoring of Medication Adherence, on the Risk of Re-hospitalisation of Ambulatory Schizophrenic Patients. an Open, Prospective, Randomised Controled Trial
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse.
Read the detailed description
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse. The study is an uni center, open, prospective, randomised and controlled.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Tele-medicine monitoring of medication adherence
- Keywords
- schizophrenia, Schizoaffective Disorder, disease management, treatment, rehabilitation, pharmacotherapy
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-medicine monitoring of medication adherenceOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tele-medicine monitoring | Experimental | Tele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment Receives: Other: Tele-medicine monitoring of medication adherence |
| No Intervention: Control Rutine out-patient treatment | No intervention | routine out-patient treatment will be given to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to re-hospitalisation
Time to re-hospitalisation will be compared in the study group and in the control group during the follow-up period of up to one year
Measured: 1 year
Secondary outcomes (1)
number of re-hospitalisations
number of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up.
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 posted20 Nov 2012 (estimated)
- Study startJan 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- SHL Telemedicine Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729572
- Sponsor's protocol ID
- 0004-12-SHA
- Status last verified
- Apr 2014
- First submitted
- 14 Nov 2012
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of add-on Tele Medicine Monitoring of Medication Adherence, on the Risk of Re-hospitalisation of Ambulatory Schizophrenic Patients. an Open, Prospective, Randomised Controled Trial
- ClinicalTrials.gov ID
- NCT01729572
- Acronym / sponsor ID
- 0004-12-SHA
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, Schizoaffective Disorder, disease management, treatment, rehabilitation, pharmacotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- SHL Telemedicine Ltd.
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 20 Nov 2012 (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.
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse.
Detailed description
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse. The study is an uni center, open, prospective, randomised and controlled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Tele-medicine monitoring | Experimental | Other: Tele-medicine monitoring of medication adherenceTele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment |
| No Intervention: Control Rutine out-patient treatment | No intervention | –routine out-patient treatment will be given to the control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM 4 diagnosis of schizophrenia or schizoaffective
- able to give written informed consent
- Have a telephone line
Key exclusion criteria (5 listed)
- Are not discharged to a place with routine medication monitoring
- Are not discharged under forced ambulatory treatment order
- Are not homeless
- Are not admitted due to drug intoxication or withdrawal.
- Are not admitted due to severe self harm.
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 |
|---|---|---|
| Tele-medicine monitoring of medication adherence | Other | Experimental: Tele-medicine monitoring |
Primary outcome
Time to re-hospitalisation
Time frame: 1 year
Time to re-hospitalisation will be compared in the study group and in the control group during the follow-up period of up to one year
1 secondary outcome
number of re-hospitalisations
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-medicine monitoring of medication adherence in people with Schizophrenia and Schizoaffective Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
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 3 inclusion and 5 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 Israel Krieger, Dr. Med (+97297478665, israelkr@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to re-hospitalisation (time frame: 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 25 Apr 2014.