Terminally Ill PatientsNCT07469878
Mobile Shared Decision-Making Program for ICU Caregivers
A study testing Experimental: Mobile technology devices in people with Terminally Ill Patients, run by CHIA-HUI MA at 1 site in Taiwan.
Trial summary
By developing a smart mobile shared decision-making (SDM) model, this study aims to assist family members of critically ill end-stage patients in making appropriate decisions, enhance their decision quality, and evaluate the model's effectiveness Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Terminally Ill Patients
- What is being tested?
- Experimental: Mobile technology devices
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Aug 2021to 9 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -Patients diagnosed with terminal cancer or the eight designated non-cancer terminal diseases.
- Patients determined to have a terminal and irreversible condition by two attending physicians.
- Primary family decision-makers who are aged 20 years or older and provide informed consent to participate in the study.
- Able to communicate in Mandarin or Taiwanese and possess basic literacy skills.
Who cannot join
- Cases where all family members reside abroad and have appointed an alternative healthcare proxy.
- Those who have already received end-of-life decision-making consultations prior to ICU admission.
- Patients who already have a Do Not Resuscitate (DNR) status annotated and have confirmed their end-of-life care preferences.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mobile Technology Share Decision-Making Program for Critically Ill Patients' Caregiver in Intensive Care Unit.
By developing a smart mobile shared decision-making (SDM) model, this study aims to assist family members of critically ill end-stage patients in making appropriate decisions, enhance their decision quality, and evaluate the model's effectiveness
Read the detailed description
This study utilized a single-blind experimental design and was conducted in the intensive care unit (ICU) of a medical center in northern Taiwan. The study participants were family members responsible for making end-of-life decisions for patients diagnosed with terminally ill critical conditions. Participants were randomly assigned to either the experimental or control group using block randomization software. A total of 70 participants were enrolled, with 35 assigned to the experimental group and 35 to the control group
- Conditions
- Terminally Ill Patients
- Being tested
- Experimental: Mobile technology devices, Placebo Comparator: Placebo
- Keywords
- Mobile technology devices, Terminally ill patients in critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Mobile technology devicesOther
Phase 1 primarily involved scheduling the family meeting and providing decision aids. Family members used smartphones or tablet computers to download a mobile health application or scanned a QR code to access the content. They were instructed to complete reviewing the materials prior to the next phase.
Phase 2 took place within three days, during which the medical team and family members convened a family meeting in the ICU conference room. The team accompanied the family in watching an approximately four-minute video titled 'End-of-Life Options,' explained the details of end-of-life care, and assisted them in selecting appropriate care plans
Placebo Comparator: PlaceboOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| Mobile technology devices | Experimental | mHealth tools 7days Receives: Other: Experimental: Mobile technology devices |
| Placebo | Placebo comparator | Usual Care Receives: Other: Placebo Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
To evaluate the changes in decisional conflict among family members."The Decisional Conflict Scale (DCS) was employed to measure participants' uncertainty in making choices. The scale comprises 16 items across five subscales, with a total score exceeding 37.5 indicating significant decisional conflict. The instrument has demonstrated robust internal consistency (Cronbach's alpha = 0.78 - 0.92)."
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start28 Aug 2021
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminally Ill PatientsStudies 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
- Model description
- Randomly assigned to an experimental group and a control group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHIA-HUI MA
- Sponsor type
- University, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Responsible party
- Sponsor-investigator, CHIA-HUI MA, Mackay Memorial Hospital
- Investigators
- MA C HUI, Study chair, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469878
- Sponsor's protocol ID
- 21MMHIS127e
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Technology Share Decision-Making Program for Critically Ill Patients' Caregiver in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT07469878
- Acronym / sponsor ID
- 21MMHIS127e
- Conditions
- Terminally Ill Patients
- Keywords
- Mobile technology devices, Terminally ill patients in critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CHIA-HUI MAUniversity, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 13 Mar 2026 (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.
By developing a smart mobile shared decision-making (SDM) model, this study aims to assist family members of critically ill end-stage patients in making appropriate decisions, enhance their decision quality, and evaluate the model's effectiveness
Detailed description
This study utilized a single-blind experimental design and was conducted in the intensive care unit (ICU) of a medical center in northern Taiwan. The study participants were family members responsible for making end-of-life decisions for patients diagnosed with terminally ill critical conditions. Participants were randomly assigned to either the experimental or control group using block randomization software. A total of 70 participants were enrolled, with 35 assigned to the experimental group and 35 to the control group
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomly assigned to an experimental group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Mobile technology devices | Experimental | Other: Experimental: Mobile technology devicesmHealth tools 7days |
| Placebo | Placebo comparator | Other: Placebo Comparator: PlaceboUsual Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- -Patients diagnosed with terminal cancer or the eight designated non-cancer terminal diseases.
- Patients determined to have a terminal and irreversible condition by two attending physicians.
- Primary family decision-makers who are aged 20 years or older and provide informed consent to participate in the study.
- Able to communicate in Mandarin or Taiwanese and possess basic literacy skills.
Key exclusion criteria (3 listed)
- Cases where all family members reside abroad and have appointed an alternative healthcare proxy.
- Those who have already received end-of-life decision-making consultations prior to ICU admission.
- Patients who already have a Do Not Resuscitate (DNR) status annotated and have confirmed their end-of-life care preferences.
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 |
|---|---|---|
| Experimental: Mobile technology devicesPhase 1 primarily involved scheduling the family meeting and providing decision aids. Family members used smartphones or tablet computers to download a mobile health application or scanned a QR code to access the content. They were instructed to complete reviewing the materials prior to the next phase. Phase 2 took place within three days, during which the medical team and family members convened a family meeting in the ICU conference room. The team accompanied the family in watching an approximately four-minute video titled 'End-of-Life Options,' explained the details of end-of-life care, and assisted them in selecting appropriate care plans | Other | Mobile technology devices |
| Placebo Comparator: Placebousual care | Other | Placebo |
Primary outcome
Decisional Conflict
Time frame: 7days
To evaluate the changes in decisional conflict among family members."The Decisional Conflict Scale (DCS) was employed to measure participants' uncertainty in making choices. The scale comprises 16 items across five subscales, with a total score exceeding 37.5 indicating significant decisional conflict. The instrument has demonstrated robust internal consistency (Cronbach's alpha = 0.78 - 0.92)."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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.
MA C HUI study chair
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Mobile technology devices in people with Terminally Ill Patients, run by CHIA-HUI MA 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 3 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: finished, as of the sponsor's last update on 13 Mar 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decisional Conflict (time frame: 7days). 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 13 Mar 2026.