StrokeNCT07235839
The Impact of an Advance Care Planning Game on Life-Sustaining Treatment Preferences, Depression, and Hope in Older Adults With Stroke
A study testing ACP Block Game Intervention in people with Stroke and Advance Care Planning, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Stroke, Advance Care Planning
- What is being tested?
- ACP Block Game Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jan 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals diagnosed with chronic psychiatric disorders such as major depression, mania, or bipolar disorder.
- Older adults diagnosed with moderate to severe dementia.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background:
Stroke is the third leading cause of death worldwide and one of the most common causes of disability, accounting for approximately 10% of all deaths. One in four people experiences a stroke in their lifetime, and about 10% of stroke survivors face the risk of recurrent stroke within five years, often with more severe symptoms than the first episode. The one-year and five-year mortality rates after stroke are as high as 41% and 60%, respectively. Due to its high incidence, high recurrence rate, and high mortality, many stroke patients are unable to express their values and treatment preferences during the course of illness. This underscores the necessity of engaging in Advance Care Planning (ACP) discussions after stroke.
Purpose:
This study aims to explore the effects of an ACP game intervention on life-sustaining treatment preferences, depression, and hope among older adults with stroke.
Design:
A randomized controlled trial design was adopted.
Participants:
Using purposive sampling, we recruited subacute stroke patients aged 65-100 years from the neurology, neurosurgery, and rehabilitation wards of a regional teaching hospital in eastern Taiwan.
Measurement Tools:
The Life Support Preferences Questionnaire (LSPQ) was used as the primary outcome measure to assess differences in life-sustaining treatment preferences immediately after the intervention and at week 4 post-intervention. Secondary outcome measures included the Hospital Anxiety and Depression Scale (HADS) and the Herth Hope Index (HHI).
Intervention:
The intervention utilized the "LOHAS Journey" ACP block-based game developed for this study. The game incorporates travel-themed scenario guidance, allowing participants to express their medical preferences through the arrangement of blocks. "Hope blocks" were added to transform various stroke- and cancer-related scenarios, enhancing the participants' sense of hope. The game also includes companion option cards, emphasizing personal resources and potential future surrogate decision-makers. Beyond discussing life-sustaining treatment preferences, the game further encourages warm emotional expressions such as gratitude and affection.
Statistical Analysis:
Generalized Estimating Equations (GEE) were used to examine differences in life-sustaining treatment preferences, depression, and hope across repeated measurements, as well as to analyze time and group interaction effects.
If the effectiveness of the ACP block-based game on life-sustaining treatment preferences, depression, and hope among older adults with stroke is confirmed, it will support the promotion of ACP-related discussions in clinical stroke care.
- Conditions
- Stroke, Advance Care Planning
- Being tested
- ACP Block Game Intervention
- Keywords
- stroke, Advance Care Planning, game, depression, hope
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP Block Game InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ACP Block Game Intervention | Experimental | Not described Receives: Other: ACP Block Game Intervention |
| Usual Care | No intervention | Routine stroke care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 5 weeks
Secondary outcomes (2)
hospital anxiety and depression scale; HADS
This scale is used to screen for the prevalence of anxiety and depression among patients in medical settings who do not have psychiatric disorders. It contains 14 items, with a total score ranging from 0 to 21. Scores of 0-7 are considered within the normal range; scores of 8-10 indicate borderline or potential anxiety or depressive symptoms; and scores of ≥11 suggest the possible presence of emotional disorders or underlying conditions. Higher scores indicate more severe anxiety or depressive symptoms.
Measured: From enrollment to the end of treatment at 5 weeks
herth hope index; HHI
This scale is used to assess the level of hope among patients with acute, chronic, or terminal illnesses. It consists of 12 items, with a total score ranging from 12 to 48. Higher scores indicate a higher level of hope.
Measured: From enrollment to the end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start29 Jan 2026
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chun Chien, Lotung Poh-Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235839
- Sponsor's protocol ID
- IRB114-220-B
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Advance Care Planning Game on Life-Sustaining Treatment Preferences, Depression, and Hope in Older Adults With Stroke
- ClinicalTrials.gov ID
- NCT07235839
- Acronym / sponsor ID
- IRB114-220-B
- Conditions
- Stroke, Advance Care Planning
- Keywords
- stroke, Advance Care Planning, game, depression, hope
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Stroke is the third leading cause of death worldwide and one of the most common causes of disability, accounting for approximately 10% of all deaths. One in four people experiences a stroke in their lifetime, and about 10% of stroke survivors face the risk of recurrent stroke within five years, often with more severe symptoms than the first episode. The one-year and five-year mortality rates after stroke are as high as 41% and 60%, respectively. Due to its high incidence, high recurrence rate, and high mortality, many stroke patients are unable to express their values and treatment preferences during the course of illness. This underscores the necessity of engaging in Advance Care Planning (ACP) discussions after stroke.
Purpose:
This study aims to explore the effects of an ACP game intervention on life-sustaining treatment preferences, depression, and hope among older adults with stroke.
Design:
A randomized controlled trial design was adopted.
Participants:
Using purposive sampling, we recruited subacute stroke patients aged 65-100 years from the neurology, neurosurgery, and rehabilitation wards of a regional teaching hospital in eastern Taiwan.
Measurement Tools:
The Life Support Preferences Questionnaire (LSPQ) was used as the primary outcome measure to assess differences in life-sustaining treatment preferences immediately after the intervention and at week 4 post-intervention. Secondary outcome measures included the Hospital Anxiety and Depression Scale (HADS) and the Herth Hope Index (HHI).
Intervention:
The intervention utilized the "LOHAS Journey" ACP block-based game developed for this study. The game incorporates travel-themed scenario guidance, allowing participants to express their medical preferences through the arrangement of blocks. "Hope blocks" were added to transform various stroke- and cancer-related scenarios, enhancing the participants' sense of hope. The game also includes companion option cards, emphasizing personal resources and potential future surrogate decision-makers. Beyond discussing life-sustaining treatment preferences, the game further encourages warm emotional expressions such as gratitude and affection.
Statistical Analysis:
Generalized Estimating Equations (GEE) were used to examine differences in life-sustaining treatment preferences, depression, and hope across repeated measurements, as well as to analyze time and group interaction effects.
If the effectiveness of the ACP block-based game on life-sustaining treatment preferences, depression, and hope among older adults with stroke is confirmed, it will support the promotion of ACP-related discussions in clinical stroke care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP Block Game Intervention | Experimental | Other: ACP Block Game Intervention |
| Usual Care | No intervention | –Routine stroke care |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals diagnosed with chronic psychiatric disorders such as major depression, mania, or bipolar disorder.
- Older adults diagnosed with moderate to severe dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP Block Game InterventionThe "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. | Other | ACP Block Game Intervention |
Primary outcome
life support preferences questionnaire; LSPQ
Time frame: From enrollment to the end of treatment at 5 weeks
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.
2 secondary outcomes
hospital anxiety and depression scale; HADS
Time frame: From enrollment to the end of treatment at 5 weeks
herth hope index; HHI
Time frame: From enrollment to the end of treatment at 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP Block Game Intervention in people with Stroke and Advance Care Planning, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
life support preferences questionnaire; LSPQ (time frame: From enrollment to the end of treatment at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.