NCT04203407

Brief Summary

This proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP behaviours among Chinese community-dwelling older adults. This is a mixed methods study with the quantitative paradigm being the main research approached used. The quantitative arm will be a randomized controlled trial (RCT). The qualitative arm will adopt focus group interviews for data collection. Recruited subjects from the community centres will be randomly allocated to the intervention and control group. The older adults in the experimental group will receive an ACP board game delivered by trained facilitators, whereas the older adults in the control group will receive another board game about healthy lifestyle. The outcome measures of the older adults will include the ACP Engagement scale, the Life-Support Preferences Questionnaire (LSPQ), a self-developed ACP knowledge questionnaire and those data will be collected at baseline (T0), immediately post-intervention(T1), at 1 month (T2), and 3 month (T3). The qualitative arm of this study will contribute to the understanding of issues and effects of ACP game as an intervention. Its finding will complement the results obtained from the RCT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

December 15, 2019

Last Update Submit

January 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Advance Care Planning Engagement Scale

    Behaviour changes in ACP behaviours measured using Advance Care Planning Engagement Scale. It is about different ACP behavior on a 5-point Likert scale. The higher score means the higher level of self-efficacy and readiness for the behaviours.

    3 months

Secondary Outcomes (2)

  • Certainty rate of end-of-life preferences toward medical care

    3 months

  • Self-develped ACP knowledge questionnaire

    3 months

Other Outcomes (2)

  • Change of emotional status

    Immediate post-intervention

  • Experience of playing ACP game

    Immediate post-intervention

Study Arms (2)

ACP game

EXPERIMENTAL

Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project.

Behavioral: ACP game

Usual care

ACTIVE COMPARATOR

Participants in the control group will receive a 1-hour board game about health lifestyle.

Behavioral: Usual care

Interventions

ACP gameBEHAVIORAL

Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project.

ACP game
Usual careBEHAVIORAL

Participants in the control group will receive a 1-hour board game about health lifestyle.

Usual care

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60 years or over;
  • speak Chinese.

You may not qualify if:

  • uncommunicable because of language barrier or sensory impairment;
  • have been referred to the palliative care service at the time of recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xihu community, guanshaling community

Changsha, Hunan, China

Location

Study Officials

  • Li LIU

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 18, 2019

Study Start

August 8, 2020

Primary Completion

December 25, 2020

Study Completion

December 25, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations