Trial Review

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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] 263067 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 270803 0
Condition category
Condition code
Neurological 270995 270995 0 0
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] 269418 0
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] 279658 0
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] 279658 0
Baseline and after each of 6 study visits (over 3 weeks) during which carers will deliver activities.
Secondary outcome [1] 294145 0
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] 294145 0
Baseline and after the 6 visits (over 3 weeks).
Secondary outcome [2] 294146 0
Carers' overall perception of mastery - Pearlin Mastery Scale.
Timepoint [2] 294146 0
Baseline and after the 6 visits (over 3 weeks).
Secondary outcome [3] 294147 0
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] 294147 0
Baseline and after the 6 visits (over 3 weeks).
Secondary outcome [4] 294148 0
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] 294148 0
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?
No
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
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269890 0
Charities/Societies/Foundations
Name [1] 269890 0
Alzheimer's Australia
Country [1] 269890 0
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] 268904 0
Hospital
Name [1] 268904 0
Southern Health
Address [1] 268904 0
246 Clayton Road
Clayton
Victoria 3168
Country [1] 268904 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271857 0
Southern Health HREC
Ethics committee address [1] 271857 0
Ethics committee country [1] 271857 0
Australia
Date submitted for ethics approval [1] 271857 0
Approval date [1] 271857 0
02/09/2011
Ethics approval number [1] 271857 0
11218B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33181 0
Address 33181 0
Country 33181 0
Phone 33181 0
Fax 33181 0
Email 33181 0
Contact person for public queries
Name 16428 0
Eva van der Ploeg
Address 16428 0
Monash University
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road, Cheltenham, Victoria 3192
Country 16428 0
Australia
Phone 16428 0
+61 3 9265 1707
Fax 16428 0
+61 3 9265 1711
Email 16428 0
[email protected]
Contact person for scientific queries
Name 7356 0
Eva van der Ploeg
Address 7356 0
Monash University
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road, Cheltenham, Victoria 3192
Country 7356 0
Australia
Phone 7356 0
+61 3 9265 1707
Fax 7356 0
+61 3 9265 1711
Email 7356 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA cluster-randomized crossover trial of Montessori activities delivered by family carers to nursing home residents with behavioral and psychological symptoms of dementia.2020https://dx.doi.org/10.1017/S1041610219001819
N.B. These documents automatically identified may not have been verified by the study sponsor.