Measuring the Effect of Remote Monitoring of Treatment Adherence on the Risk of Re-admission of Ambulatory Schizophrenic Patients

• Sponsor: Shalvata Mental Health Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01729572
• Collaborator: SHL Telemedicine Ltd. (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 10.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Other: Tele-medicine monitoring of medication adherence	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Aug 1, 2015
• Anticipated Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Tele-medicine monitoring Tele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment	Other: Tele-medicine monitoring of medication adherence
No Intervention: No Intervention: Control Rutine out-patient treatment routine out-patient treatment will be given to the control group

Outcome Measures

Primary Outcome Measures

1. Time to re-hospitalisation [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

Secondary Outcome Measures

1. number of re-hospitalisations [1 year]

   number of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up.

Other Outcome Measures

1. Total time in hospital [1 year]

   Total time in hospital during the 1 year follow-up period will be compared between the study and the control groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• DSM 4 diagnosis of schizophrenia or schizoaffective

• able to give written informed consent

• Have a telephone line

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shalvata MHC	Hod-Hasharon		Israel	45100

Sponsors and Collaborators

• Shalvata Mental Health Center
• SHL Telemedicine Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shalvata Mental Health Center
• ClinicalTrials.gov Identifier: NCT01729572
• Other Study ID Numbers: 0004-12-SHA
• First Posted: Nov 20, 2012
• Last Update Posted: Apr 25, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Shalvata Mental Health Center: schizophrenia; Schizoaffective Disorder; disease management; treatment; rehabilitation; pharmacotherapy
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders

Study Results

No Results Posted as of Apr 25, 2014