ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12611000998943

Ethics application status

Approved

Date submitted

19/09/2011

Date registered

19/09/2011

Date last updated

20/09/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

A cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia

Scientific title

The impact of family-mediated personalised activities for nursing home residents with dementia on quality of visits, quality of relationships and carers' wellbeing: a cluster randomised controlled trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Condition category

Condition code

Neurological

Dementias

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

We will train family members of nursing home residents to apply personalised one-to-one activities based on the Montessori approach with their relative.

Montessori-based activities follow the principles espoused by Maria Montessori and subsequent educational theorists who promoted engagement in learning by sequencing tasks from simple to complex; providing cues to successful completion; encouraging repetition, and carefully matching demands to individuals’ interests and levels of competence (Camp, 1999; Camp et al., 2006). For people with dementia, Montessori-type programs entail detailed interviews with family carers about their former interests and skills coupled with assessments of cognitive, language and motor skills. A range of activities are then presented, tested and refined. When dementia is advanced, the activities themselves are simple (e.g. completing a jigsaw made from a family photograph). Facilitators present tasks deliberately, modelling them first and using little language if preferred. The main objective is to engage participants’ interest and involvement.

Family carers will be trained in the principles underpinning Montessori activities in three-hour group sessions in their relative’s facility. A pair of researchers will conduct these workshops. They will spend half an hour helping carers to fill out the baseline questionnaires; an hour explaining the theoretical basis of Montessori activities in dementia, and an hour and a half in smaller groups brainstorming possible about activities and then practising them.

Intervention code [1]

Other interventions

Comparator / control treatment

Waitlist control group, incl. dementia education session to match for interaction with researchers during activities workshop.

The control group will participate in the Montessori workshop asap after they completed all the measurements for the waitlist period. As the participants are randomised on facility basis and the participating facilities are scattered across Melbourne and Victoria, we do not expect contamination between the two groups.

Control group

Active

Outcomes

Primary outcome [1]

Quality of visits as measured by a truncated version of the Pearlin Mastery Scale (Pearlin & Schooler, 1978) adapted to care-related situations (Pioli, 2010).

Timepoint [1]

Baseline and after each of 6 study visits (over 3 weeks) during which carers will deliver activities.

Secondary outcome [1]

Quality of relationship, measured using the 15-item Mutuality Scale of the Family Caregiving Inventory which measures the positive aspects of relationship quality using the dimensions love, shared pleasurable activities, shared values, and reciprocity (Archbold et al., 1990).

Timepoint [1]

Baseline and after the 6 visits (over 3 weeks).

Secondary outcome [2]

Carers' overall perception of mastery - Pearlin Mastery Scale.

Timepoint [2]

Baseline and after the 6 visits (over 3 weeks).

Secondary outcome [3]

Carers' mood - Center for Epidemiological Studies Depression Scale is a 20-item self-report scale of depressive symptoms covering mood, self-esteem, energy, relationships, sleep and appetite (CES-D; Radloff & Teri, 1986).

Timepoint [3]

Baseline and after the 6 visits (over 3 weeks).

Secondary outcome [4]

Carers' quality of life - The Carer-QoL (Brouwer et al., 2006) is a short, seven-item self-report questionnaire concerning difficulties with physical and mental health, finances and social support.

Timepoint [4]

Baseline and after the 6 visits (over 3 weeks).

Eligibility

Key inclusion criteria

Inclusion criteria for residents: (i) A chart diagnosis of dementia or probable dementia; and (ii) residency in the facility for over 3 months to allow for adjustment to the new setting.

Inclusion criteria for family carers: (i) Visit regularly 2 or more times per week for 30 minutes or more to match study requirements, (ii) willing to follow study protocol, and (iii) sufficient fluency in English to understand the workshop and fill out questionnaires.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criterion for residents: Acute life-threatening illness as reported by nursing staff.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

We will employ a cluster-randomised trial to allocate a condition (treatment vs. waiting list) on facility level. The study will extend over a brief period to reduce the likelihood that changes in outcomes are due to dementia progression, inter-current illness or other incidental events. Activity sessions must be long enough to detect changes in selected outcomes during the carer’s visit, but not so long that sessions are likely to be interrupted by meals or nursing interventions. In our current Montessori study, the choice of 30-minute sessions has worked well. A study period of up to four weeks has also proved feasible. We therefore propose an exposure of six sessions spread over a three week period for the experimental condition. Allocation was concealed using computer based randomisation of facilities.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The choice of condition (Group A or B) will be randomly determined using Excel using unique numbers.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/11/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Alzheimer's Australia

Address [1]

National Quality Dementia Care Network

Alzheimer's Australia National Office
1 Frewin Place, Scullin, ACT, 2614

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Monash University
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road, Cheltenham, Victoria 3192

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Southern Health

Address [1]

246 Clayton Road
Clayton
Victoria 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health HREC

Ethics committee address [1]

Research Directorate
Level 4, Main Block
Monash Medical Centre
Clayton Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/09/2011

Ethics approval number [1]

11218B

Summary

Brief summary

Background
Following admission to a nursing home, the feelings of depression and burden that family carers may experience do not necessarily diminish. Additionally, they may experience feelings of guilt and grief for the loss of a previously close relationship. At the same time, individuals with dementia may develop symptoms of depression and agitation (BPSD) that may be related to changes in family relationships, social interaction and stimulation. Until now, interventions to alleviate carer stress and BPSD have treated carers and relatives separately rather than focusing on maintaining or enhancing their relationships. One-to-one structured activities have been shown to reduce BPSD and also improve the caring experience, but barriers exist to the implementation of activities in aged care facilities, for example lack of resources. The current study will investigate the effect of individualised activities based on the Montessori methodology administered by family carers in residential care. 
Methods/ Design
We will conduct a cluster-randomised trial to train family carers in conducting personalised one-to-one activities based on the Montessori methodology with their relatives. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. Persons with dementia living in aged care facilities and frequently visiting family carers will be included in the study. Consented, willing participants will on facility level be randomly assigned to a treatment condition using the Montessori approach or a control waiting list condition. We hypothesise that family carers conducting Montessori-based activities will experience improvements in quality of visits and overall relationship with the resident as well as higher self-rated mastery, fewer depressive symptoms, and a better quality of life than carers in the waiting list condition.
Discussion Training family carers to deliver personalised activities to their relatives in a residential setting may make visits more satisfying and improve the quality of life for carers and their relatives. These beneficial effects might also reduce nursing staff burden and thus impact positively on residential facilities.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Eva van der Ploeg

Address

Monash University
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road, Cheltenham, Victoria 3192

Country

Australia

Phone

+61 3 9265 1707

Fax

+61 3 9265 1711

Eva.vanderPloeg@monash.edu

Contact person for scientific queries

Name

Eva van der Ploeg

Address

Monash University
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road, Cheltenham, Victoria 3192

Country

Australia

Phone

+61 3 9265 1707

Fax

+61 3 9265 1711

Eva.vanderPloeg@monash.edu

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A cluster-randomized crossover trial of Montessori activities delivered by family carers to nursing home residents with behavioral and psychological symptoms of dementia.	2020	https://dx.doi.org/10.1017/S1041610219001819

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically