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Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults

Primary Purpose

Advance Care Planning, Game, Older Adults

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ACP game
Usual care
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advance Care Planning

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 60 years or over;
  • speak Chinese.

Exclusion Criteria:

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

Sites / Locations

  • Xihu community, guanshaling community

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACP game

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Certainty rate of end-of-life preferences toward medical care
End-of-life preferences is measured by the Life-Support Preferences Questionnaire (LSPQ). It describes one hypothetical terminally ill scenario. Preferences regarding (i) three kinds of life-sustaining treatments (cardiopulmonary resuscitation, mechanical ventilator and tube feeding) based on three options (want to attempt, refuse or uncertain) and (ii) care goals (comfort-oriented, prolongation of life at all costs or uncertain) , will be asked.
Self-develped ACP knowledge questionnaire
The questionnaire comprised 10 questions. Response options for each of these questions were "yes" and "no". Content validity was assessed within a palliative care expert team.

Full Information

First Posted
December 15, 2019
Last Updated
January 25, 2021
Sponsor
Chinese University of Hong Kong
Collaborators
Xihu community healthcare service centre, Guanshaling community healthcare service centre
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1. Study Identification

Unique Protocol Identification Number
NCT04203407
Brief Title
Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults
Official Title
Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game on Self-efficacy and ACP Behaviors Among Chinese Older Adults: a Mixed Method Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2020 (Actual)
Primary Completion Date
December 25, 2020 (Actual)
Study Completion Date
December 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Xihu community healthcare service centre, Guanshaling community healthcare service centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Care Planning, Game, Older Adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACP game
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive a 1-hour board game about health lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
ACP game
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Participants in the control group will receive a 1-hour board game about health lifestyle.
Primary Outcome Measure Information:
Title
Advance Care Planning Engagement Scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Certainty rate of end-of-life preferences toward medical care
Description
End-of-life preferences is measured by the Life-Support Preferences Questionnaire (LSPQ). It describes one hypothetical terminally ill scenario. Preferences regarding (i) three kinds of life-sustaining treatments (cardiopulmonary resuscitation, mechanical ventilator and tube feeding) based on three options (want to attempt, refuse or uncertain) and (ii) care goals (comfort-oriented, prolongation of life at all costs or uncertain) , will be asked.
Time Frame
3 months
Title
Self-develped ACP knowledge questionnaire
Description
The questionnaire comprised 10 questions. Response options for each of these questions were "yes" and "no". Content validity was assessed within a palliative care expert team.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change of emotional status
Description
Emotional status is measured using the Chinese version of the 7-item Generalized Anxiety Disorder ( GAD-7) scale as process indicators. The total score ranges from 0 to 21. Higher scores indicate higher level of anxiety.
Time Frame
Immediate post-intervention
Title
Experience of playing ACP game
Description
Participants' experience of playing ACP game will be collected by focus group interviews.
Time Frame
Immediate post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 60 years or over; speak Chinese. Exclusion Criteria: uncommunicable because of language barrier or sensory impairment; have been referred to the palliative care service at the time of recruitment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li LIU
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xihu community, guanshaling community
City
Changsha
State/Province
Hunan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults

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