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

NCT04490135 | Completed

• 1 other identifier: CARERSMountSinaiH
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Carer Stress Syndrome

Keywords

Carer; Psychotherapy; Problem solving; Simulation; Dementia

Outcome Measures

Primary Outcomes (9)

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

  standardized diagnostic measure of depression

  Change in depression score from baseline at 8 weeks

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

  self assessment standardized measure of self perceived stress

  Change in stress score from baseline at 8 weeks

• Mastery (Pearlin et al., 1990)

  self assessment standardized measure of perceived sense of mastery in caregiving

  Change in mastery score from baseline 8 weeks

• caregiving competence(Pearlin et al., 1990)

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

  Change in caregiving competence score from baseline at 8 weeks

• role captivity (Pearlin et al., 1990)

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

  Change in role captivity score from baseline at 8 weeks

• role overload(Pearlin et al., 1990)

  self administered standardized measure of degree of experienced caregiving overload

  Change in role overload score from baseline at 8 weeks

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

  Self administered Standardized measure of burden of caregiving

  Change in burden score from baseline at 8 weeks

• coping (Endler and Parker 1990)

  Self administered scale of caregiver's perception of coping

  Change from Baseline at 8 weeks

• coping (Endler & Parker, 1990)

  Self administered scale of caregivers perception of coping

  Change in coping from baseline at 8 weeks

Secondary Outcomes (4)

• Caregiver demographics

  through study completion on average about 4 months

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

  change from Baseline at 8 weeks

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

  Change from Baseline at 8 weeks

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

  Baseline and after completion of the 8 week intervention

Study Arms (2)

Carers group intervention

EXPERIMENTAL

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

Behavioral: Group psychotherapy

Wating list control

NO INTERVENTION

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)

Interventions

Group psychotherapy BEHAVIORAL

As described above

Carers group intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Joel Sadavoy

Toronto, Ontario, M5p3c3, Canada

Location

MeSH Terms

Conditions

Dementia

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joel Sadavoy

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Reitman Centre

Model Details: a quasi-experimental design with a convenience sample and a non-randomized wait-list control group

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 28, 2020
• Study Start: January 1, 2013
• Primary Completion: September 30, 2017
• Study Completion: December 31, 2017
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)