Play Intervention for Dementia for Promoting Cognitive Function: A Feasibility Study

NCT02846415 | Completed Results DMC

• 1 other identifier: 4-ZZFU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to use Play Intervention for Dementia (PID) to promote cognitive functions of people with early to moderate dementia. This is a cluster randomized controlled trial aims to recruit 38 participants from two study sites. Participants will be randomly allocated into intervention or wait-list controlled groups. Both groups will receive the same content of PID programme at different time. The PID consists of 12 weekly sessions. Each session lasts for 45-75 minutes. The PID will be facilitated by a play specialist, trained elderly volunteers, and centre staffs. Cognitive functions will be evaluated with Montreal Cognitive Assessment, Fuld Object Memory Evaluation and Modified Verbal Fluency Test, conducted by a trained research assistant blinded to group allocation. Centre staffs (not involved in the PID) will be interviewed. Every alternate session will be video-taped for understanding the experience of the participants in the PID programme.

Conditions

Dementia; Alzheimer Disease

Keywords

Dementia; Play and Playthings; Cognition; Memory

Outcome Measures

Primary Outcomes (1)

• Adjusted Post-test Score of Montreal Cognitive Assessment Scale After 2 Months of Intervention

  The Hong Kong version of the 11-item Montreal Cognitive Assessment scale was used to measure the global cognitive functions of the participants. The scores range from 0 to 30, and lower scores refer to lower levels of cognitive function. The scores reported are the adjusted post-test mean scores using its baseline measures as a covariate in ANCOVA.

  At Baseline, after 2 months (T1)

Secondary Outcomes (2)

• Adjusted Post-test Score of Fuld Object Memory Evaluation - Total Storage Score

  At Baseline, after 2 months (T1)

• Adjusted Post-test Score of the Modified Verbal Fluency Test

  At Baseline, after 2 months (T1)

Study Arms (2)

PID group

EXPERIMENTAL

Experimental group receiving the Play Intervention for Dementia

Behavioral: Play Intervention for Dementia

Wait-list control group

NO INTERVENTION

Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.

Interventions

Play Intervention for Dementia BEHAVIORAL

1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff.

PID group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community dwelling, at the age of 65 or above
• With a medical confirmed diagnosis of any type of dementia (such as Alzheimer's disease, vascular dementia, etc.).
• At the stage of early to moderate dementia, at the stage of 4-6 screened by Global Deterioration Scale

You may not qualify if:

• Unable to sit independently and participate in table activities
• Physically unstable
• Dislikes group activity

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (6)

• Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD005562. doi: 10.1002/14651858.CD005562.pub2.

  PMID: 22336813 BACKGROUND

• Connelly LM. Pilot studies. Medsurg Nurs. 2008 Dec;17(6):411-2. No abstract available.

  PMID: 19248407 BACKGROUND

• Chung JC. Clinical validity of Fuld Object Memory Evaluation to screen for dementia in a Chinese society. Int J Geriatr Psychiatry. 2009 Feb;24(2):156-62. doi: 10.1002/gps.2085.

  PMID: 18612999 BACKGROUND

• Chiu HF, Chan CK, Lam LC, Ng KO, Li SW, Wong M, Chan WF. The modified Fuld Verbal Fluency Test: a validation study in Hong Kong. J Gerontol B Psychol Sci Soc Sci. 1997 Sep;52(5):P247-50. doi: 10.1093/geronb/52b.5.p247.

  PMID: 9310094 BACKGROUND

• Fuld PA. Fuld Object Memory Evaluation Manual. Stoelting: Wood Dale, IL.1981.

  BACKGROUND

• Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.

  PMID: 25125421 BACKGROUND

Related Links

• Application of Play Intervention for Dementia

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

We do not yet know whether additional sessions or more frequently held sessions of the CoS-Play would lead to greater efficacy.

Results Point of Contact

• Title: Dr Daphne Cheung
• Organization: School of Nursing, The Hong Kong Polytechnic University

cheungdaphne@polyu.edu.hk

+852 27664534

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 27, 2016
• Study Start: August 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: December 31, 2017
• Last Updated: October 23, 2023
• Results First Posted: December 3, 2020

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)