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Completed

NCT Number: NCT04490135

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joel Sadavoy

Toronto, Ontario, M5p3c3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Psychotherapy

Behavioral

As described above

Primary outcomes

  1. Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977

    Time frame: Change in depression score from baseline at 8 weeks

    standardized diagnostic measure of depression

  2. perceived stress scale - PSS Cohen, S et al., 1983

    Time frame: Change in stress score from baseline at 8 weeks

    self assessment standardized measure of self perceived stress

  3. Mastery (Pearlin et al., 1990)

    Time frame: Change in mastery score from baseline 8 weeks

    self assessment standardized measure of perceived sense of mastery in caregiving

  4. caregiving competence(Pearlin et al., 1990)

    Time frame: Change in caregiving competence score from baseline at 8 weeks

    Self assessment standardized measure of key areas of perceived competence in caregiving

  5. role captivity (Pearlin et al., 1990)

    Time frame: Change in role captivity score from baseline at 8 weeks

    Self administered standardized measure of degree of perceived entrapment in the caregiving role

  6. role overload(Pearlin et al., 1990)

    Time frame: Change in role overload score from baseline at 8 weeks

    self administered standardized measure of degree of experienced caregiving overload

  7. Short Zarit Burden Inventory- SZBI), (Bedard et al., 2001)

    Time frame: Change in burden score from baseline at 8 weeks

    Self administered Standardized measure of burden of caregiving

  8. coping (Endler and Parker 1990)

    Time frame: Change from Baseline at 8 weeks

    Self administered scale of caregiver's perception of coping

  9. coping (Endler & Parker, 1990)

    Time frame: Change in coping from baseline at 8 weeks

    Self administered scale of caregivers perception of coping

Secondary outcomes

  1. Caregiver demographics

    Time frame: through study completion on average about 4 months

    general demographic profile

  2. Katz Index of Independence in Activities of Daily Living (Katz ADL) (Katz, Downs, Cash, & Grotz, 1970)

    Time frame: change from Baseline at 8 weeks

    Measure of care recipient daily function as observed by caregiver

  3. Lawton Instrumental Activities of Daily Living Scale (Lawton ADL) (Lawton & Brody, 1969)

    Time frame: Change from Baseline at 8 weeks

    measure of care recipients daily instrumental activities of daily living as observed by the caregiver

  4. Revised Memory and Behaviour Checklist- RMBPC) (Teri et al., 1992)

    Time frame: Baseline and after completion of the 8 week intervention

    Caregiver's reaction to CR's memory and behavioural symptoms (completed by caregiver)

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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