<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03837340</url>
  </required_header>
  <id_info>
    <org_study_id>779362</org_study_id>
    <secondary_id>779362RECOVER-E H2020</secondary_id>
    <secondary_id>U1111-1226-8617</secondary_id>
    <secondary_id>SPH-3463/1</secondary_id>
    <secondary_id>PHI-01-8396</secondary_id>
    <nct_id>NCT03837340</nct_id>
  </id_info>
  <brief_title>Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health</brief_title>
  <acronym>RECOVER-E</acronym>
  <official_title>Large-scale Implementation of Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Special Psychiatric Hospital Kotor</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>STICHTING TRIMBOS INSTITUT, NETHERLANDS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Special Psychiatric Hospital Kotor</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-blinded hybrid effectiveness-implementation trial (Type II), that both evaluates the&#xD;
      intervention outcomes (clinical and service use outcomes) through patient-randomization in&#xD;
      the implementation sites, as well as evaluates the implementation strategy chosen for the&#xD;
      intervention and its impact on implementation outcomes (e.g. adoption, fidelity,&#xD;
      acceptability and maintenance (continued implementation) of the intervention).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of the study is to contribute to improving the level of functioning and&#xD;
      quality of life and mental health outcomes for people with severe and enduring mental ill&#xD;
      health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and upscaling the&#xD;
      implementation of a community-based service delivery model in Montenegro.&#xD;
&#xD;
      Effectiveness component of the trial: Multidisciplinary community mental health teams for&#xD;
      people with SMI.&#xD;
&#xD;
      The intervention condition offers flexible, assertive community treatment (FACT) in the&#xD;
      community for people with SMI. FACT can intensify (e.g. provide more intensive treatment in&#xD;
      the form of daily home visits, crisis care at home, more intensive evidence-based&#xD;
      psycho-social and pharmacological treatments) or provide less intensive treatment depending&#xD;
      on client need. It can also provide less intensive care during non-crisis periods, offering&#xD;
      routine home treatment where a combination of psychological and pharmacological treatments&#xD;
      (e.g. cognitive behavioral therapy, motivational interviewing, family-based interventions)&#xD;
      are offered, as well as care processes (reviewing recovery and crisis/treatment plans, and&#xD;
      the clients' Wellness Recovery Action Plan), and social care interventions (assistance in&#xD;
      obtaining or maintaining employment, looking for reasonable accommodation options).&#xD;
&#xD;
      Care offered in this project in the intervention condition will be provided by a&#xD;
      multidisciplinary community mental health team (CMHT), consisting of a diverse set of&#xD;
      professionals including psychiatrists, psychologists, nurses, and social workers, that&#xD;
      deliver integrated medical and social care that are focused on (symptomatic-, functional- and&#xD;
      personal-) recovery.&#xD;
&#xD;
      CMHTs will provide home-based treatment inclusive of crisis resolution services and&#xD;
      procedures for early recognition of sub-clinical psychosis and bipolar disorder, ACT, and&#xD;
      intensive case management. Integrated care (i.e. health and social care interventions) will&#xD;
      be provided to all clients. Furthermore, health and social care evidence-based interventions&#xD;
      for severe mental illnesses will be employed during home treatment, such as family-based&#xD;
      interventions, motivational interviewing, and cognitive behavioral therapies, combined with&#xD;
      medication management and identifying employment (paid and unpaid options) and support in&#xD;
      finding and maintaining this employment, (Wellness Recovery Action Plan (WRAP) recovery&#xD;
      groups and housing opportunities.&#xD;
&#xD;
      Comparison condition: Usual care Health care settings and their providers randomized to the&#xD;
      control condition receive usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>There are two study arms- groups - both consisting of patients with SMI (severe mental illness). One group will be receiving care as usual, which in the actual setting means mostly medical treatment, without home care and assertive treatment through community based outreach teams. Another, intervention group, will be receiving assertive treatment care, with mobile assertive teams, consisting of at least three team members.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in daily functioning</measure>
    <time_frame>Baseline, 12 months and 18 months</time_frame>
    <description>World Health Organisation Disability Assessment Schedule 2 (WHO-DAS2) measures health and disability-level of functioning in 6 domains:1.Cognition - understanding and communicating; 2.Mobility - moving and getting around; 3.Self-care - attending to one's hygiene,dressing, eating and staying alone; 4.Getting along - interacting with others; 5. Life activities - domestic responsibilities, leisure, work and school; 6.Participation in community activities,in society.The instrument is self-reporting; can be administered by a health worker if needed.Answers are distributed into 5 categories:&quot;none&quot;,&quot;mild&quot;,&quot;moderate&quot;,&quot;severe&quot;and&quot;extreme or cannot do&quot;. It ends with 3 items where answers are presented as number of days (when difficulties were present). Score on any dimension ranges 0 to 7, results are depicted in a diagram which reflects relation between dimensions(the higher the score, the lower level of difficulties/better functioning) and changes over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in health-related quality of life</measure>
    <time_frame>Baseline, 12 months and 18 months</time_frame>
    <description>Euro Quality of Life Index (Euro QoL 5-D 3-L). The instrument measures five dimensions:Dimension 1: Mobility; Dimension 2: Self-care;Dimension 3:Daily activities; Dimension 4: pain/discomfort; Dimension 5: Anxiety/ Depression.&#xD;
Each dimension can be rated at three levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 33333 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Severe Mental Disorders</condition>
  <condition>Schizophrenia</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Severe Depression</condition>
  <arm_group>
    <arm_group_label>FACT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with SMI, receiving evidence-based interventions by the community mental health teams (CMHTs), inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAU (Care as usual)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with SMI receiving usual care, meaning mostly medical treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CMHT</intervention_name>
    <description>Community mental health teams (CMHTs) delivering evidence-based interventions to people with SMI, inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.</description>
    <arm_group_label>FACT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CAU</intervention_name>
    <description>Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication.</description>
    <arm_group_label>CAU (Care as usual)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (ages 18-65), current service users, with severe and enduring mental&#xD;
             ill-health, which, for clinical purposes, typically relates to diagnostic categories&#xD;
             of bipolar disorder, severe depression, or schizophrenia. We use the following&#xD;
             definition for SMI:&#xD;
&#xD;
               -  Presence of a psychiatric disorder that requires care and treatment (so, they are&#xD;
                  NOT in symptom remission)&#xD;
&#xD;
               -  Has severe limitations in social and community functioning (i.e. they are not in&#xD;
                  functional remission)&#xD;
&#xD;
               -  These problems are not transient (e.g. temporary, one-off) in nature (They are&#xD;
                  systematic and long-term)&#xD;
&#xD;
               -  Coordinated care provided by care networks or teams is needed to implement the&#xD;
                  treatment plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria at the patient level includes patients who do not consent to their&#xD;
             data being collected who are part of the intervention or control conditions, those who&#xD;
             are under the age of 18 at the start of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aleksandar Tomcuk</last_name>
    <role>Principal Investigator</role>
    <affiliation>Special Psychiatric Hospital Kotor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ZU Specijalna bolnica za psihijatriju Dobrota Kotor</name>
      <address>
        <city>Kotor</city>
        <zip>85330</zip>
        <country>Montenegro</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Montenegro</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community mental health teams</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data will be shared with the coordinating institute and Heidelberg University Hospital, the two institutions that will be in charge of analyzing data from all participating project sites.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>During the project - and for a period of five years after the end of the project - each beneficiary will disseminate its results by disclosing them to the public by appropriate means as soon as possible, including scientific publications in any medium.</ipd_time_frame>
    <ipd_access_criteria>In order to protect participant privacy, data will only be released if the request abides by national and European patient data laws and guidelines, by guidelines for use of mental health data, and by the guidelines set by each research site's ethical review board. Those requesting access to the data will be asked to verify their identity, provide information on how the data will be used, and provide information about their institutions. All requests and releases of data will be logged by the Data Protection Officer.All identifiable data will be kept confidential and will not be released.&#xD;
Data access will be limited to a need only basis. All research partners involved in RECOVER-E will have access to open data sets. As well, datasets will be made available to the European Commission or Global Alliance for Chronic Diseases on request. All de-identified data sets will be stored at the coordinating institute on password-protected, non-networked servers with limited access.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03837340
org study id: 779362
secondary id: 779362RECOVER-E H2020
secondary id: U1111-1226-8617
secondary id: SPH-3463/1
secondary id: PHI-01-8396
nct id: NCT03837340
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A single-blinded hybrid effectiveness-implementation trial (Type II), that both evaluates the
      intervention outcomes (clinical and service use outcomes) through patient-randomization in
      the implementation sites, as well as evaluates the implementation strategy chosen for the
      intervention and its impact on implementation outcomes (e.g. adoption, fidelity,
      acceptability and maintenance (continued implementation) of the intervention).
The overall goal of the study is to contribute to improving the level of functioning and
      quality of life and mental health outcomes for people with severe and enduring mental ill
      health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and upscaling the
      implementation of a community-based service delivery model in Montenegro.

      Effectiveness component of the trial: Multidisciplinary community mental health teams for
      people with SMI.

      The intervention condition offers flexible, assertive community treatment (FACT) in the
      community for people with SMI. FACT can intensify (e.g. provide more intensive treatment in
      the form of daily home visits, crisis care at home, more intensive evidence-based
      psycho-social and pharmacological treatments) or provide less intensive treatment depending
      on client need. It can also provide less intensive care during non-crisis periods, offering
      routine home treatment where a combination of psychological and pharmacological treatments
      (e.g. cognitive behavioral therapy, motivational interviewing, family-based interventions)
      are offered, as well as care processes (reviewing recovery and crisis/treatment plans, and
      the clients' Wellness Recovery Action Plan), and social care interventions (assistance in
      obtaining or maintaining employment, looking for reasonable accommodation options).

      Care offered in this project in the intervention condition will be provided by a
      multidisciplinary community mental health team (CMHT), consisting of a diverse set of
      professionals including psychiatrists, psychologists, nurses, and social workers, that
      deliver integrated medical and social care that are focused on (symptomatic-, functional- and
      personal-) recovery.

      CMHTs will provide home-based treatment inclusive of crisis resolution services and
      procedures for early recognition of sub-clinical psychosis and bipolar disorder, ACT, and
      intensive case management. Integrated care (i.e. health and social care interventions) will
      be provided to all clients. Furthermore, health and social care evidence-based interventions
      for severe mental illnesses will be employed during home treatment, such as family-based
      interventions, motivational interviewing, and cognitive behavioral therapies, combined with
      medication management and identifying employment (paid and unpaid options) and support in
      finding and maintaining this employment, (Wellness Recovery Action Plan (WRAP) recovery
      groups and housing opportunities.

      Comparison condition: Usual care Health care settings and their providers randomized to the
      control condition receive usual care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are two study arms- groups - both consisting of patients with SMI (severe mental illness). One group will be receiving care as usual, which in the actual setting means mostly medical treatment, without home care and assertive treatment through community based outreach teams. Another, intervention group, will be receiving assertive treatment care, with mobile assertive teams, consisting of at least three team members.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Changes in daily functioning
time frame: Baseline, 12 months and 18 months
description: World Health Organisation Disability Assessment Schedule 2 (WHO-DAS2) measures health and disability-level of functioning in 6 domains:1.Cognition - understanding and communicating; 2.Mobility - moving and getting around; 3.Self-care - attending to one's hygiene,dressing, eating and staying alone; 4.Getting along - interacting with others; 5. Life activities - domestic responsibilities, leisure, work and school; 6.Participation in community activities,in society.The instrument is self-reporting; can be administered by a health worker if needed.Answers are distributed into 5 categories:"none","mild","moderate","severe"and"extreme or cannot do". It ends with 3 items where answers are presented as number of days (when difficulties were present). Score on any dimension ranges 0 to 7, results are depicted in a diagram which reflects relation between dimensions(the higher the score, the lower level of difficulties/better functioning) and changes over time.
measure: Change in health-related quality of life
time frame: Baseline, 12 months and 18 months
description: Euro Quality of Life Index (Euro QoL 5-D 3-L). The instrument measures five dimensions:Dimension 1: Mobility; Dimension 2: Self-care;Dimension 3:Daily activities; Dimension 4: pain/discomfort; Dimension 5: Anxiety/ Depression.
Each dimension can be rated at three levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 33333 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state.
arm group label: FACT
arm group type: Experimental
description: Patients with SMI, receiving evidence-based interventions by the community mental health teams (CMHTs), inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.
arm group label: CAU (Care as usual)
arm group type: Active Comparator
description: Patients with SMI receiving usual care, meaning mostly medical treatment
intervention type: Other
intervention name: CMHT
description: Community mental health teams (CMHTs) delivering evidence-based interventions to people with SMI, inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.
arm group label: FACT
intervention type: Other
intervention name: CAU
description: Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication.
arm group label: CAU (Care as usual)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Aleksandar Tomcuk
role: Principal Investigator
affiliation: Special Psychiatric Hospital Kotor
facility: 
country: Montenegro
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: De-identified individual participant data will be shared with the coordinating institute and Heidelberg University Hospital, the two institutions that will be in charge of analyzing data from all participating project sites.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: During the project - and for a period of five years after the end of the project - each beneficiary will disseminate its results by disclosing them to the public by appropriate means as soon as possible, including scientific publications in any medium.
ipd access criteria: In order to protect participant privacy, data will only be released if the request abides by national and European patient data laws and guidelines, by guidelines for use of mental health data, and by the guidelines set by each research site's ethical review board. Those requesting access to the data will be asked to verify their identity, provide information on how the data will be used, and provide information about their institutions. All requests and releases of data will be logged by the Data Protection Officer.All identifiable data will be kept confidential and will not be released.
Data access will be limited to a need only basis. All research partners involved in RECOVER-E will have access to open data sets. As well, datasets will be made available to the European Commission or Global Alliance for Chronic Diseases on request. All de-identified data sets will be stored at the coordinating institute on password-protected, non-networked servers with limited access.