Critical IllnessNCT07278713
Family-Participatory Early Rehabilitation in Critically Ill Patients
A study testing Internet-Based, Family-Participatory Early Rehabilitation (IFPER) and Standard ICU Care in people with Critical Illness, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This prospective, randomized controlled trial aims to evaluate the efficacy of an Internet-Based, Family-Participatory Early Rehabilitation (IFPER) model compared to standard care for critically ill patients in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Internet-Based, Family-Participatory Early Rehabilitation (IFPER) and Standard ICU Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Expected ICU stay of more than 48 hours
- Hemodynamic stability (mean arterial pressure 65-110 mmHg with no or low-dose vasopressor support)
- Stable respiratory status (PaO2/FiO2 > 200 mmHg, SpO2 ≥ 88%)
- Richmond Agitation-Sedation Scale (RASS) score ≥ -2
- Having at least one family member willing and able to participate
Who cannot join
- Unstable cardiovascular conditions (e.g., acute coronary syndrome, malignant arrhythmia)
- Acute neurological injury with unstable intracranial pressure
- Unstable fractures or spinal cord injury
- Active, uncontrolled bleeding
- Pre-existing severe psychiatric disorders or dementia
- Inability to provide consent and no available legal surrogate
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Effect of an Internet-Based, Mobile Terminal-Supported, Family-Participatory Early Rehabilitation Model on Sleep Improvement and Stigma Prevention in Critically Ill Patients: A Randomized Controlled Trial
This prospective, randomized controlled trial aims to evaluate the efficacy of an Internet-Based, Family-Participatory Early Rehabilitation (IFPER) model compared to standard care for critically ill patients in the Intensive Care Unit (ICU). The study will determine if the IFPER model, which is based on a structured "7P Rehabilitation" framework, can improve sleep quality, reduce the perception of critical illness-related social stigma, and alleviate procedural pain.
Read the detailed description
Critically ill patients often suffer from Post-Intensive Care Syndrome (PICS), which includes severe sleep disturbances, pain, and psychological issues like social stigma. While family involvement in care is known to be beneficial, structured, technology-supported models are scarce. This study was designed to address this gap by testing a novel IFPER model. A total of 204 adult patients admitted to the ICU were randomized to either the IFPER group or a standard care group. The IFPER intervention involves trained family members using a mobile application to deliver a structured, multi-component rehabilitation program based on the "7P Rehabilitation Model" (Position Management, Pain \& Sedation, Physiotherapeutics, Pulmonary Rehabilitation, Psychological Rehabilitation, Performance Rebuilding, Purpose \& Belonging). The standard care group received routine ICU care. The study hypothesizes that this structured, family-centered approach will lead to significantly better outcomes in sleep, stigma perception, and pain management compared to standard care alone.
- Conditions
- Critical Illness
- Being tested
- Internet-Based, Family-Participatory Early Rehabilitation (IFPER), Standard ICU Care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based, Family-Participatory Early Rehabilitation (IFPER)Behavioural
A structured, multi-component rehabilitation program facilitated by trained family members using a mobile application for guidance and communication, based on the "7P Rehabilitation Model."
Standard ICU CareBehavioural
Routine ICU care including medical support and standard rehabilitation delivered by ICU staff.
| Study group | Role | What they receive |
|---|---|---|
| Internet-Based, Family-Participatory Early Rehabilitation (IFPER) Group | Experimental | In addition to standard care, patients received a structured, family-participatory early rehabilitation program guided by the "7P Rehabilitation Pyramid Model." Trained family members used a mobile application to assist with activities including Position Management, Pain \& Sedation Management, Physiotherapeutics, Pulmonary Rehabilitation, Psychological Rehabilitation, Performance Rebuilding, and fostering Purpose \& Belonging. The sessions were conducted for 30-45 minutes, twice daily. Receives: Behavioral: Internet-Based, Family-Participatory Early Rehabilitation (IFPER) |
| Standard Care Group | Active comparator | Patients received routine ICU care, which included standard medical and supportive care, daily assessments, sedation management, pain control, nutritional support, and standard early rehabilitation protocols delivered by the ICU physical therapy team. Receives: Behavioral: Standard ICU Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Efficiency
Measured by polysomnography (PSG). Sleep efficiency is calculated as (total sleep time / time in bed) × 100%. The change is assessed from baseline to the day before ICU discharge.
Measured: From enrollment through ICU discharge, an average of 10 days
Secondary outcomes (9)
Social Stigma Score
Measured by the Social Stigma in Critical Illness (SSCI) scale. The scale ranges from 10 to 50. A higher score indicates a worse outcome (greater perceived stigma).
Measured: At ICU discharge, an average of 10 days after enrollment
Procedural Pain Scores
Assessed daily using the Numeric Rating Scale (NRS) for communicative patients and the Critical-Care Pain Observation Tool (CPOT) for non-communicative patients. The NRS is on a 0-10 scale, and the CPOT is on a 0-8 scale. For both scales, a higher score indicates a worse outcome (more pain).
Measured: Through ICU stay, an average of 10 days
Duration of Mechanical Ventilation
The total number of days a patient requires mechanical ventilation.
Measured: Through ICU stay, an average of 7 days
ICU Length of Stay
The total number of days a patient stays in the ICU.
Measured: Through study completion, an average of 10 days
Incidence of Delirium
The percentage of patients who develop delirium, assessed twice daily using the Confusion Assessment Method for the ICU (CAM-ICU).
Measured: Through ICU stay, an average of 10 days
Change in Percentage of REM Sleep
Change in the percentage of Rapid Eye Movement (REM) sleep, measured by polysomnography (PSG).
Measured: From enrollment through ICU discharge, an average of 10 days
Change in Percentage of N1 Sleep
Change in the percentage of Stage 1 non-REM sleep, measured by polysomnography (PSG).
Measured: From enrollment through ICU discharge, an average of 10 days
Change in Percentage of N2 Sleep
Change in the percentage of Stage 3 non-REM (slow-wave) sleep, measured by polysomnography (PSG).
Measured: From enrollment through ICU discharge, an average of 10 days
Change in Arousal Index
Change in the number of arousals or awakenings per hour of sleep, measured by polysomnography (PSG).
Measured: From enrollment through ICU discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Jul 2022
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiao Ke, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278713
- Sponsor's protocol ID
- 2022S00433
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Internet-Based, Mobile Terminal-Supported, Family-Participatory Early Rehabilitation Model on Sleep Improvement and Stigma Prevention in Critically Ill Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07278713
- Acronym / sponsor ID
- 2022S00433
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 Dec 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.
This prospective, randomized controlled trial aims to evaluate the efficacy of an Internet-Based, Family-Participatory Early Rehabilitation (IFPER) model compared to standard care for critically ill patients in the Intensive Care Unit (ICU). The study will determine if the IFPER model, which is based on a structured "7P Rehabilitation" framework, can improve sleep quality, reduce the perception of critical illness-related social stigma, and alleviate procedural pain.
Detailed description
Critically ill patients often suffer from Post-Intensive Care Syndrome (PICS), which includes severe sleep disturbances, pain, and psychological issues like social stigma. While family involvement in care is known to be beneficial, structured, technology-supported models are scarce. This study was designed to address this gap by testing a novel IFPER model. A total of 204 adult patients admitted to the ICU were randomized to either the IFPER group or a standard care group. The IFPER intervention involves trained family members using a mobile application to deliver a structured, multi-component rehabilitation program based on the "7P Rehabilitation Model" (Position Management, Pain \& Sedation, Physiotherapeutics, Pulmonary Rehabilitation, Psychological Rehabilitation, Performance Rebuilding, Purpose \& Belonging). The standard care group received routine ICU care. The study hypothesizes that this structured, family-centered approach will lead to significantly better outcomes in sleep, stigma perception, and pain management compared to standard care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-Based, Family-Participatory Early Rehabilitation (IFPER) Group | Experimental | Behavioral: Internet-Based, Family-Participatory Early Rehabilitation (IFPER)In addition to standard care, patients received a structured, family-participatory early rehabilitation program guided by the "7P Rehabilitation Pyramid Model." Trained family members used a mobile application to assist with activities including Position Management, Pain \& Sedation Management, Physiotherapeutics, Pulmonary Rehabilitation, Psychological Rehabilitation, Performance Rebuilding, and fostering Purpose \& Belonging. The sessions were conducted for 30-45 minutes, twice daily. |
| Standard Care Group | Active comparator | Behavioral: Standard ICU CarePatients received routine ICU care, which included standard medical and supportive care, daily assessments, sedation management, pain control, nutritional support, and standard early rehabilitation protocols delivered by the ICU physical therapy team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Expected ICU stay of more than 48 hours
- Hemodynamic stability (mean arterial pressure 65-110 mmHg with no or low-dose vasopressor support)
- Stable respiratory status (PaO2/FiO2 > 200 mmHg, SpO2 ≥ 88%)
- Richmond Agitation-Sedation Scale (RASS) score ≥ -2
Key exclusion criteria (6 listed)
- Unstable cardiovascular conditions (e.g., acute coronary syndrome, malignant arrhythmia)
- Acute neurological injury with unstable intracranial pressure
- Unstable fractures or spinal cord injury
- Active, uncontrolled bleeding
- Pre-existing severe psychiatric disorders or 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 |
|---|---|---|
| Internet-Based, Family-Participatory Early Rehabilitation (IFPER)A structured, multi-component rehabilitation program facilitated by trained family members using a mobile application for guidance and communication, based on the "7P Rehabilitation Model." | Behavioural | Internet-Based, Family-Participatory Early Rehabilitation (IFPER) Group |
| Standard ICU CareRoutine ICU care including medical support and standard rehabilitation delivered by ICU staff. | Behavioural | Standard Care Group |
Primary outcome
Change in Sleep Efficiency
Time frame: From enrollment through ICU discharge, an average of 10 days
Measured by polysomnography (PSG). Sleep efficiency is calculated as (total sleep time / time in bed) × 100%. The change is assessed from baseline to the day before ICU discharge.
9 secondary outcomes
Social Stigma Score
Time frame: At ICU discharge, an average of 10 days after enrollment
Procedural Pain Scores
Time frame: Through ICU stay, an average of 10 days
Duration of Mechanical Ventilation
Time frame: Through ICU stay, an average of 7 days
ICU Length of Stay
Time frame: Through study completion, an average of 10 days
Incidence of Delirium
Time frame: Through ICU stay, an average of 10 days
Change in Percentage of REM Sleep
Time frame: From enrollment through ICU discharge, an average of 10 days
Change in Percentage of N1 Sleep
Time frame: From enrollment through ICU discharge, an average of 10 days
Change in Percentage of N2 Sleep
Time frame: From enrollment through ICU discharge, an average of 10 days
Change in Arousal Index
Time frame: From enrollment through ICU discharge, an average of 10 days
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 12 Dec 2025.
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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 Internet-Based, Family-Participatory Early Rehabilitation (IFPER) and Standard ICU Care in people with Critical Illness, run by The First Hospital of Hebei Medical University at 1 site in China.
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 6 inclusion and 6 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 12 Dec 2025. 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 China. 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?
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?
Change in Sleep Efficiency (time frame: From enrollment through ICU discharge, an average of 10 days). 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 12 Dec 2025.