<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/NCT04490135</url>
  </required_header>
  <id_info>
    <org_study_id>CARERSMountSinaiH</org_study_id>
    <nct_id>NCT04490135</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia</brief_title>
  <official_title>Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</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>
      Family caregivers (CG) of persons with dementia are vulnerable to disproportionate physical,&#xD;
      mental and social adverse health consequences . The Reitman Centre CARERS program is an&#xD;
      innovative, group psychotherapeutic skills-training intervention.&#xD;
&#xD;
      Study objective: to determine the effectiveness of the Reitman Centre CARERS program on key&#xD;
      outcomes in family CGs of people with dementia. Study sample: Family CGs of people with&#xD;
      dementia (n=264) referred to Reitman Center and the partner sites and wait-list control group&#xD;
      (n=83) who received regular care. Method: quasi-experimental, non-randomized, multiple group&#xD;
      trial; participants were evaluated before and after completion of the 8-week CARERS program&#xD;
      in comparison.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Addressing the adverse effects of caregiving on dementia CGs has been an increasing concern&#xD;
      of mental and social health scholars in recent decades. Many single and multi-component&#xD;
      programs have been developed but evidence for the effectiveness of interventions varies.&#xD;
      Single component interventions for CGs like education, psychotherapy, or skills training are&#xD;
      effective on various outcome measures but multicomponent programs appear to be preferred for&#xD;
      overall reduction of caregiver burden. Broad development and system-wide adoption of&#xD;
      interventions lags behind and there remains a need for evidence-based interventions that can&#xD;
      be scaled widely in systems of dementia care.&#xD;
&#xD;
      This study aimed to compare the effectiveness of the Reitman Centre CARERS group intervention&#xD;
      on measures of CG's health and well-being with a usual-care intervention control group. We&#xD;
      hypothesized that the integrated, multicomponent CARERS program would produce robust positive&#xD;
      effects on key outcome measures compared to waiting list controls. This was a&#xD;
      quasi-experimental design with a convenience sample and a non-randomized wait-list control&#xD;
      group implemented between 2013 and 2017. The control group received usual care before&#xD;
      starting the CARERS intervention.The waiting list control group was derived from all CGs who&#xD;
      were clinically assessed for the CARERS program, consented to enter the study and completed&#xD;
      initial study assessments before being put on the waiting list for a CARERS group. A waiting&#xD;
      list control was employed for practical recruitment purposes. This study was approved by the&#xD;
      Sinai Health System (SHS) Research Ethics Board. Every participant provided informed signed&#xD;
      written consent for all study components.Referrals to the study came from community agencies&#xD;
      serving older adults, self-referrals, and primary care, memory, general psychiatry and&#xD;
      geriatric medicine clinics. The intervention sites were located at Reitman Centre (CR) and&#xD;
      Wellness Centre at Mount Sinai Hospital, Bridgepoint Active Health, Ceridian LifeWorks® EAP,&#xD;
      Canadian Alzheimer Society chapters and community agencies serving older adults.&#xD;
&#xD;
      The intervention, called Carers, is a multicomponent, group psychotherapeutic,&#xD;
      skills-training intervention for family CGs comprised of 8 weekly 2 hour closed groups&#xD;
      sessions. of 4-6 CGs co-led by 2 mental health clinicians who follow a protocol that includes&#xD;
      predetermined agendas that structure the outline of each group. The group leaders are trained&#xD;
      to elicit and address the specific concerns of each CG during each session. The content of&#xD;
      each group is determined by the CGs based on an initial go-round check-in to elicit current&#xD;
      caregiving problems and challenges, emotional reactions and foster group cohesion. In&#xD;
      sessions 1-4, CGs are formally taught a form of problem-solving therapy (PST) adapted for&#xD;
      dementia CGs. Sessions 5-8 utilize simulation to train CGs to effectively communicate with&#xD;
      the person they are caring for and learn how to engage with them to manage dementia induced&#xD;
      behaviours such as resistance or demandingness. Communication training is done with live&#xD;
      therapeutic simulation a hands-on training method that employs specially trained standardized&#xD;
      patients (SP) in a tightly controlled intervention developed for the CARERS program. All&#xD;
      group leaders were trained in a standardized training protocol at the Reitman Centre. CGs&#xD;
      completed self-administered questionnaires at entry to the study, just prior to starting the&#xD;
      first group and, immediately after session 8 of the group therapy. Care recipient&#xD;
      (CR)function and demographic and socioeconomic information was gathered for each CG/CR at&#xD;
      entry into the study. Statistical analysis employed IBM SPSS 26 and univariate general linear&#xD;
      model (UNIANOVA) analysis and parametric tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>a quasi-experimental design with a convenience sample and a non-randomized wait-list control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977</measure>
    <time_frame>Change in depression score from baseline at 8 weeks</time_frame>
    <description>standardized diagnostic measure of depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>perceived stress scale - PSS Cohen, S et al., 1983</measure>
    <time_frame>Change in stress score from baseline at 8 weeks</time_frame>
    <description>self assessment standardized measure of self perceived stress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mastery (Pearlin et al., 1990)</measure>
    <time_frame>Change in mastery score from baseline 8 weeks</time_frame>
    <description>self assessment standardized measure of perceived sense of mastery in caregiving</description>
  </primary_outcome>
  <primary_outcome>
    <measure>caregiving competence(Pearlin et al., 1990)</measure>
    <time_frame>Change in caregiving competence score from baseline at 8 weeks</time_frame>
    <description>Self assessment standardized measure of key areas of perceived competence in caregiving</description>
  </primary_outcome>
  <primary_outcome>
    <measure>role captivity (Pearlin et al., 1990)</measure>
    <time_frame>Change in role captivity score from baseline at 8 weeks</time_frame>
    <description>Self administered standardized measure of degree of perceived entrapment in the caregiving role</description>
  </primary_outcome>
  <primary_outcome>
    <measure>role overload(Pearlin et al., 1990)</measure>
    <time_frame>Change in role overload score from baseline at 8 weeks</time_frame>
    <description>self administered standardized measure of degree of experienced caregiving overload</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Zarit Burden Inventory- SZBI), (Bedard et al., 2001)</measure>
    <time_frame>Change in burden score from baseline at 8 weeks</time_frame>
    <description>Self administered Standardized measure of burden of caregiving</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coping (Endler and Parker 1990)</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>Self administered scale of caregiver's perception of coping</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coping (Endler &amp; Parker, 1990)</measure>
    <time_frame>Change in coping from baseline at 8 weeks</time_frame>
    <description>Self administered scale of caregivers perception of coping</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caregiver demographics</measure>
    <time_frame>through study completion on average about 4 months</time_frame>
    <description>general demographic profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Katz Index of Independence in Activities of Daily Living (Katz ADL) (Katz, Downs, Cash, &amp; Grotz, 1970)</measure>
    <time_frame>change from Baseline at 8 weeks</time_frame>
    <description>Measure of care recipient daily function as observed by caregiver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lawton Instrumental Activities of Daily Living Scale (Lawton ADL) (Lawton &amp; Brody, 1969)</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>measure of care recipients daily instrumental activities of daily living as observed by the caregiver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Memory and Behaviour Checklist- RMBPC) (Teri et al., 1992)</measure>
    <time_frame>Baseline and after completion of the 8 week intervention</time_frame>
    <description>Caregiver's reaction to CR's memory and behavioural symptoms (completed by caregiver)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">264</enrollment>
  <condition>Carer Stress Syndrome</condition>
  <arm_group>
    <arm_group_label>Carers group intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>caregivers entered into the 8 week CARERS intervention (N=264) Group intervention, 8 x 2 hour sessions. Session 1-4 PST training, session 5-8 Simulation with standardized patients training Pre- post evaluations completed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wating list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Caregivers waiting for entry into active arm of CARERS intervention.During this time usual care allowed with no other intervention. Study measures administered at intake and immediately prior to starting the CARERS group. (N=83)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group psychotherapy</intervention_name>
    <description>As described above</description>
    <arm_group_label>Carers group intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult, informal caregiver (CG) of a person with diagnosis of dementia who resided in&#xD;
             the community; sufficient emotional and physical capacity to participate in the&#xD;
             assessment and training sessions; no active suicidality or psychotic illness; willing&#xD;
             to discontinue other CG intervention programs while in the study; and provided signed&#xD;
             consent for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insufficient emotional and physical capacity to participate in the assessment and&#xD;
             training sessions; active suicidality or psychotic illness; unwilling to discontinue&#xD;
             other CG intervention programs while in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Sadavoy</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joel Sadavoy</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5p3c3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mount Sinai Hospital, Canada</investigator_affiliation>
    <investigator_full_name>Joel Sadavoy</investigator_full_name>
    <investigator_title>Medical Director Reitman Centre</investigator_title>
  </responsible_party>
  <keyword>Carer</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Problem solving</keyword>
  <keyword>Simulation</keyword>
  <keyword>Dementia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04490135
org study id: CARERSMountSinaiH
nct id: NCT04490135
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Family caregivers (CG) of persons with dementia are vulnerable to disproportionate physical,
      mental and social adverse health consequences . The Reitman Centre CARERS program is an
      innovative, group psychotherapeutic skills-training intervention.

      Study objective: to determine the effectiveness of the Reitman Centre CARERS program on key
      outcomes in family CGs of people with dementia. Study sample: Family CGs of people with
      dementia (n=264) referred to Reitman Center and the partner sites and wait-list control group
      (n=83) who received regular care. Method: quasi-experimental, non-randomized, multiple group
      trial; participants were evaluated before and after completion of the 8-week CARERS program
      in comparison.
Addressing the adverse effects of caregiving on dementia CGs has been an increasing concern
      of mental and social health scholars in recent decades. Many single and multi-component
      programs have been developed but evidence for the effectiveness of interventions varies.
      Single component interventions for CGs like education, psychotherapy, or skills training are
      effective on various outcome measures but multicomponent programs appear to be preferred for
      overall reduction of caregiver burden. Broad development and system-wide adoption of
      interventions lags behind and there remains a need for evidence-based interventions that can
      be scaled widely in systems of dementia care.

      This study aimed to compare the effectiveness of the Reitman Centre CARERS group intervention
      on measures of CG's health and well-being with a usual-care intervention control group. We
      hypothesized that the integrated, multicomponent CARERS program would produce robust positive
      effects on key outcome measures compared to waiting list controls. This was a
      quasi-experimental design with a convenience sample and a non-randomized wait-list control
      group implemented between 2013 and 2017. The control group received usual care before
      starting the CARERS intervention.The waiting list control group was derived from all CGs who
      were clinically assessed for the CARERS program, consented to enter the study and completed
      initial study assessments before being put on the waiting list for a CARERS group. A waiting
      list control was employed for practical recruitment purposes. This study was approved by the
      Sinai Health System (SHS) Research Ethics Board. Every participant provided informed signed
      written consent for all study components.Referrals to the study came from community agencies
      serving older adults, self-referrals, and primary care, memory, general psychiatry and
      geriatric medicine clinics. The intervention sites were located at Reitman Centre (CR) and
      Wellness Centre at Mount Sinai Hospital, Bridgepoint Active Health, Ceridian LifeWorks® EAP,
      Canadian Alzheimer Society chapters and community agencies serving older adults.

      The intervention, called Carers, is a multicomponent, group psychotherapeutic,
      skills-training intervention for family CGs comprised of 8 weekly 2 hour closed groups
      sessions. of 4-6 CGs co-led by 2 mental health clinicians who follow a protocol that includes
      predetermined agendas that structure the outline of each group. The group leaders are trained
      to elicit and address the specific concerns of each CG during each session. The content of
      each group is determined by the CGs based on an initial go-round check-in to elicit current
      caregiving problems and challenges, emotional reactions and foster group cohesion. In
      sessions 1-4, CGs are formally taught a form of problem-solving therapy (PST) adapted for
      dementia CGs. Sessions 5-8 utilize simulation to train CGs to effectively communicate with
      the person they are caring for and learn how to engage with them to manage dementia induced
      behaviours such as resistance or demandingness. Communication training is done with live
      therapeutic simulation a hands-on training method that employs specially trained standardized
      patients (SP) in a tightly controlled intervention developed for the CARERS program. All
      group leaders were trained in a standardized training protocol at the Reitman Centre. CGs
      completed self-administered questionnaires at entry to the study, just prior to starting the
      first group and, immediately after session 8 of the group therapy. Care recipient
      (CR)function and demographic and socioeconomic information was gathered for each CG/CR at
      entry into the study. Statistical analysis employed IBM SPSS 26 and univariate general linear
      model (UNIANOVA) analysis and parametric tests.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: a quasi-experimental design with a convenience sample and a non-randomized wait-list control group
primary purpose: Treatment
masking: None (Open Label)
measure: Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977
time frame: Change in depression score from baseline at 8 weeks
description: standardized diagnostic measure of depression
measure: perceived stress scale - PSS Cohen, S et al., 1983
time frame: Change in stress score from baseline at 8 weeks
description: self assessment standardized measure of self perceived stress
measure: Mastery (Pearlin et al., 1990)
time frame: Change in mastery score from baseline 8 weeks
description: self assessment standardized measure of perceived sense of mastery in caregiving
measure: caregiving competence(Pearlin et al., 1990)
time frame: Change in caregiving competence score from baseline at 8 weeks
description: Self assessment standardized measure of key areas of perceived competence in caregiving
measure: role captivity (Pearlin et al., 1990)
time frame: Change in role captivity score from baseline at 8 weeks
description: Self administered standardized measure of degree of perceived entrapment in the caregiving role
measure: role overload(Pearlin et al., 1990)
time frame: Change in role overload score from baseline at 8 weeks
description: self administered standardized measure of degree of experienced caregiving overload
measure: Short Zarit Burden Inventory- SZBI), (Bedard et al., 2001)
time frame: Change in burden score from baseline at 8 weeks
description: Self administered Standardized measure of burden of caregiving
measure: coping (Endler and Parker 1990)
time frame: Change from Baseline at 8 weeks
description: Self administered scale of caregiver's perception of coping
measure: coping (Endler & Parker, 1990)
time frame: Change in coping from baseline at 8 weeks
description: Self administered scale of caregivers perception of coping
measure: Caregiver demographics
time frame: through study completion on average about 4 months
description: general demographic profile
measure: Katz Index of Independence in Activities of Daily Living (Katz ADL) (Katz, Downs, Cash, & Grotz, 1970)
time frame: change from Baseline at 8 weeks
description: Measure of care recipient daily function as observed by caregiver
measure: Lawton Instrumental Activities of Daily Living Scale (Lawton ADL) (Lawton & Brody, 1969)
time frame: Change from Baseline at 8 weeks
description: measure of care recipients daily instrumental activities of daily living as observed by the caregiver
measure: Revised Memory and Behaviour Checklist- RMBPC) (Teri et al., 1992)
time frame: Baseline and after completion of the 8 week intervention
description: Caregiver's reaction to CR's memory and behavioural symptoms (completed by caregiver)
arm group label: Carers group intervention
arm group type: Experimental
description: caregivers entered into the 8 week CARERS intervention (N=264) Group intervention, 8 x 2 hour sessions. Session 1-4 PST training, session 5-8 Simulation with standardized patients training Pre- post evaluations completed
arm group label: Wating list control
arm group type: No Intervention
description: Caregivers waiting for entry into active arm of CARERS intervention.During this time usual care allowed with no other intervention. Study measures administered at intake and immediately prior to starting the CARERS group. (N=83)
intervention type: Behavioral
intervention name: Group psychotherapy
description: As described above
arm group label: Carers group intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joel Sadavoy
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Mount Sinai Hospital, Canada
investigator full name: Joel Sadavoy
investigator title: Medical Director Reitman Centre
mesh term: Dementia
sharing ipd: No