NCT07235839

Brief Summary

Stroke is the world's third leading cause of death and a major source of disability, with high rates of recurrence and mortality that often limit patients' ability to express their values and treatment preferences. This highlights the importance of Advance Care Planning (ACP) after stroke. This randomized controlled trial examined the effects of an ACP block-based game on life-sustaining treatment preferences, depression, and hope among adults aged 65-100 with subacute stroke in a regional teaching hospital. The Life Support Preferences Questionnaire (LSPQ) served as the primary outcome to assess preference changes immediately after the intervention and at four weeks, while the Hospital Anxiety and Depression Scale (HADS) and the Herth Hope Index (HHI) were secondary measures. The intervention used the "LOHAS Journey" ACP game, which applies travel-themed scenarios, blocks to express medical choices, hope-enhancing elements, and companion cards emphasizing personal resources and potential surrogate decision-makers, while also encouraging warm emotional expression. Generalized Estimating Equations (GEE) were used to analyze repeated measures and time-by-group effects. If effective, this ACP game may support broader clinical adoption of structured discussions on life-sustaining treatment preferences for older stroke patients.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress54%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

November 14, 2025

Last Update Submit

February 2, 2026

Conditions

Keywords

strokeAdvance Care Planninggamedepressionhope

Outcome Measures

Primary Outcomes (1)

  • life support preferences questionnaire; LSPQ

    The questionnaire is designed to assess participants' preferences for various life-sustaining treatments across six medical scenarios and five treatment options. The maximum possible score is 150 and the minimum is 25. Higher scores indicate a greater willingness to receive life-sustaining medical treatments.

    From enrollment to the end of treatment at 5 weeks

Secondary Outcomes (2)

  • hospital anxiety and depression scale; HADS

    From enrollment to the end of treatment at 5 weeks

  • herth hope index; HHI

    From enrollment to the end of treatment at 5 weeks

Study Arms (2)

ACP Block Game Intervention

EXPERIMENTAL
Other: ACP Block Game Intervention

Usual Care

NO INTERVENTION

Routine stroke care

Interventions

The "LOHAS Journey" Advance Care Planning (ACP) block game serves as an intervention. This non-invasive intervention, themed around a game-like journey, guides participants through various scenarios, allowing them to express their healthcare preferences through the blocks. The inclusion of "Hope Blocks" transforms several scenarios related to stroke and cancer, helping participants strengthen their hope for healthcare. The game also provides support tabs highlighting personal resources and potential future healthcare decision-makers. Beyond discussing life-sustaining treatment preferences, the game encourages expressing warm emotions such as gratitude and love.

ACP Block Game Intervention

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older adults aged 65-100 years.
  • Diagnosed with ischemic or hemorrhagic stroke confirmed by computer tomography (CT) or magnetic resonance imaging (MRI), and in the subacute stage 1-6 months after stroke onset.
  • A National Institute of Health Stroke Scale (NIHSS) score ≤ 15, indicating mild to moderate stroke severity.
  • Clear consciousness and able to communicate in Mandarin or Taiwanese.

You may not qualify if:

  • Individuals diagnosed with chronic psychiatric disorders such as major depression, mania, or bipolar disorder.
  • Older adults diagnosed with moderate to severe dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lotong PohAi Hospital

Yilan, Taiwan

Location

MeSH Terms

Conditions

StrokeDepression

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

January 29, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations