NCT02432222

Brief Summary

The study will use a randomized controlled trial to test the efficacy of two interventions (visual arts and music) for individuals with dementia, focusing on dementia of the Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or retirement residences. Participants will be tested before and after the intervention on a battery of cognitive, affective, and behavioural measures. They will be compared to a waitlist control group who don't receive the intervention. The purpose of our research is twofold: treatment of symptoms and improved quality of life during disease progression in dementia. For the primary aim, the investigators are examining the potential of arts interventions on declining functions in dementia (memory, mood, and behavior) to investigate potential treatment effects. Secondly, quality of life will be measured, with the aim of looking beyond disease progression to contribute to an overall positive patient experience. Research has indicated the need for non-pharmacological treatments to be used as a first line of action against dementia symptoms and development. While, in best practice, pharmacological treatments should be used as a second-line approach. Note: Music intervention dropped prior to study initiation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

April 1, 2015

Last Update Submit

July 11, 2016

Conditions

Outcome Measures

Primary Outcomes (5)

  • Montreal Cognitive Assessment (MOCA, change measure)

    Designed by Nasreddine (2005) for overall cognitive assessment

    baseline and 8 weeks

  • Working memory (change measure)

    Visual (body part pointing test, Stopford et al, 2010), auditory (digit span test, Weschler, 2008)

    baseline and 8 weeks

  • Rey-Osterreith test of long-term memory (change measure)

    Rey-Osterreith Complex Figure Recognition, Rey-Osterreith Figure Copy, Rey-Osterreith verbal task (Osterreith, 1944; Schmidt, 1996)

    baseline and 8 weeks

  • Trails test of set-shifting (change measure)

    Measure of set-shifting/task switching

    baseline and 8 weeks

  • Dual task for visual and auditory search (change measure)

    designed by Baddeley (2001)

    baseline and 8 weeks

Secondary Outcomes (3)

  • Behavioural psychiatric peformance (time-to-event measure)

    from date of randomization upto 8 weeks

  • Quality of Life (change measure)

    baseline and 8 weeks

  • Visual analog mood scale

    baseline and 8 weeks

Study Arms (3)

Music Training

EXPERIMENTAL

Music training

Behavioral: Music Training

Visual Arts Training

EXPERIMENTAL

Visual arts training

Behavioral: Visual Arts Training

Control

NO INTERVENTION

Waitlist control

Interventions

Visual arts training

Visual Arts Training
Music TrainingBEHAVIORAL

Music training

Music Training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • dementia

You may not qualify if:

  • known comorbid cognitive or neurological impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Melody Wiseheart, PhD

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 1, 2015

First Posted

May 4, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 13, 2016

Record last verified: 2016-07