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Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia

Primary Purpose

Carer Stress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group psychotherapy
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carer Stress Syndrome focused on measuring Carer, Psychotherapy, Problem solving, Simulation, Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult, informal caregiver (CG) of a person with diagnosis of dementia who resided in the community; sufficient emotional and physical capacity to participate in the assessment and training sessions; no active suicidality or psychotic illness; willing to discontinue other CG intervention programs while in the study; and provided signed consent for the study.

Exclusion Criteria:

  • insufficient emotional and physical capacity to participate in the assessment and training sessions; active suicidality or psychotic illness; unwilling to discontinue other CG intervention programs while in the study

Sites / Locations

  • Joel Sadavoy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Carers group intervention

Wating list control

Arm 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

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)

Outcomes

Primary Outcome Measures

Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977
standardized diagnostic measure of depression
perceived stress scale - PSS Cohen, S et al., 1983
self assessment standardized measure of self perceived stress
Mastery (Pearlin et al., 1990)
self assessment standardized measure of perceived sense of mastery in caregiving
caregiving competence(Pearlin et al., 1990)
Self assessment standardized measure of key areas of perceived competence in caregiving
role captivity (Pearlin et al., 1990)
Self administered standardized measure of degree of perceived entrapment in the caregiving role
role overload(Pearlin et al., 1990)
self administered standardized measure of degree of experienced caregiving overload
Short Zarit Burden Inventory- SZBI), (Bedard et al., 2001)
Self administered Standardized measure of burden of caregiving
coping (Endler and Parker 1990)
Self administered scale of caregiver's perception of coping
coping (Endler & Parker, 1990)
Self administered scale of caregivers perception of coping

Secondary Outcome Measures

Caregiver demographics
general demographic profile
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Katz, Downs, Cash, & Grotz, 1970)
Measure of care recipient daily function as observed by caregiver
Lawton Instrumental Activities of Daily Living Scale (Lawton ADL) (Lawton & Brody, 1969)
measure of care recipients daily instrumental activities of daily living as observed by the caregiver
Revised Memory and Behaviour Checklist- RMBPC) (Teri et al., 1992)
Caregiver's reaction to CR's memory and behavioural symptoms (completed by caregiver)

Full Information

First Posted
July 21, 2020
Last Updated
July 27, 2020
Sponsor
Mount Sinai Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04490135
Brief Title
Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia
Official Title
Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carer Stress Syndrome
Keywords
Carer, Psychotherapy, Problem solving, Simulation, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a quasi-experimental design with a convenience sample and a non-randomized wait-list control group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carers group intervention
Arm Type
Experimental
Arm 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 Title
Wating list control
Arm Type
No Intervention
Arm 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(s)
Group psychotherapy
Intervention Description
As described above
Primary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977
Description
standardized diagnostic measure of depression
Time Frame
Change in depression score from baseline at 8 weeks
Title
perceived stress scale - PSS Cohen, S et al., 1983
Description
self assessment standardized measure of self perceived stress
Time Frame
Change in stress score from baseline at 8 weeks
Title
Mastery (Pearlin et al., 1990)
Description
self assessment standardized measure of perceived sense of mastery in caregiving
Time Frame
Change in mastery score from baseline 8 weeks
Title
caregiving competence(Pearlin et al., 1990)
Description
Self assessment standardized measure of key areas of perceived competence in caregiving
Time Frame
Change in caregiving competence score from baseline at 8 weeks
Title
role captivity (Pearlin et al., 1990)
Description
Self administered standardized measure of degree of perceived entrapment in the caregiving role
Time Frame
Change in role captivity score from baseline at 8 weeks
Title
role overload(Pearlin et al., 1990)
Description
self administered standardized measure of degree of experienced caregiving overload
Time Frame
Change in role overload score from baseline at 8 weeks
Title
Short Zarit Burden Inventory- SZBI), (Bedard et al., 2001)
Description
Self administered Standardized measure of burden of caregiving
Time Frame
Change in burden score from baseline at 8 weeks
Title
coping (Endler and Parker 1990)
Description
Self administered scale of caregiver's perception of coping
Time Frame
Change from Baseline at 8 weeks
Title
coping (Endler & Parker, 1990)
Description
Self administered scale of caregivers perception of coping
Time Frame
Change in coping from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Caregiver demographics
Description
general demographic profile
Time Frame
through study completion on average about 4 months
Title
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Katz, Downs, Cash, & Grotz, 1970)
Description
Measure of care recipient daily function as observed by caregiver
Time Frame
change from Baseline at 8 weeks
Title
Lawton Instrumental Activities of Daily Living Scale (Lawton ADL) (Lawton & Brody, 1969)
Description
measure of care recipients daily instrumental activities of daily living as observed by the caregiver
Time Frame
Change from Baseline at 8 weeks
Title
Revised Memory and Behaviour Checklist- RMBPC) (Teri et al., 1992)
Description
Caregiver's reaction to CR's memory and behavioural symptoms (completed by caregiver)
Time Frame
Baseline and after completion of the 8 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult, informal caregiver (CG) of a person with diagnosis of dementia who resided in the community; sufficient emotional and physical capacity to participate in the assessment and training sessions; no active suicidality or psychotic illness; willing to discontinue other CG intervention programs while in the study; and provided signed consent for the study. Exclusion Criteria: insufficient emotional and physical capacity to participate in the assessment and training sessions; active suicidality or psychotic illness; unwilling to discontinue other CG intervention programs while in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Sadavoy
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joel Sadavoy
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5p3c3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia

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