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

January 25, 2021 updated by: LIU Li, Chinese University of Hong Kong

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hunan
      • Changsha, Hunan, China
        • Xihu community, guanshaling community

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ACP game
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 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.
ACTIVE_COMPARATOR: Usual care
Participants in the control group will receive a 1-hour board game about health lifestyle.
Participants in the control group will receive a 1-hour board game about health lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advance Care Planning Engagement Scale
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Certainty rate of end-of-life preferences toward medical care
Time Frame: 3 months
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.
3 months
Self-develped ACP knowledge questionnaire
Time Frame: 3 months
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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of emotional status
Time Frame: Immediate post-intervention
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.
Immediate post-intervention
Experience of playing ACP game
Time Frame: Immediate post-intervention
Participants' experience of playing ACP game will be collected by focus group interviews.
Immediate post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Li LIU, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 8, 2020

Primary Completion (ACTUAL)

December 25, 2020

Study Completion (ACTUAL)

December 25, 2020

Study Registration Dates

First Submitted

December 15, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC2019428
  • ChiCTR1900028190 (REGISTRY: Chinese Clinical Trial Registry, ChiCTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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