The Effects of a Respiratory Assistive Device Health Education Manual on Readmission Rates and Self-Care Efficacy: A Randomized Controlled Trial
Discharge Planning for Patients Requiring Respiratory Assistive Devices
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 80 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This study evaluates whether adding an easy-to-read, illustrated education booklet to routine discharge planning helps patients and their family caregivers safely use home respiratory equipment.
Patients who need breathing devices after leaving the hospital often face challenges managing equipment and recognizing warning symptoms, which can lead to complications or hospital readmissions. Participants in this study are randomly assigned (by chance) to one of two groups: one group receives standard hospital discharge instructions, while the other group receives the standard instructions along with a specialized, step-by-step respiratory care booklet. Researchers will assess how prepared patients feel to return home the day before discharge, and will follow up by phone one week later to check on device use, daily care confidence, and any unexpected doctor or emergency room visits.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Hospitalized patients enrolled in the discharge planning service of Fu Jen Catholic University Hospital who are evaluated as requiring referral to respiratory assistive devices, long-term care services, or home respiratory care facilities/resources.
- Evaluated and confirmed by the hospital healthcare team as in need of discharge planning services specifically related to respiratory assistive devices.
- Aged 18 years or older.
- Able to comprehend the study purpose and provide written informed consent (if the patient is unable to communicate or express consent, a primary caregiver may provide consent and complete responses on their behalf).
Exclusion Criteria:
- Patients receiving palliative or hospice care with an anticipated life expectancy of less than 1 month.
- Patients with altered consciousness or dementia who do not have an eligible primary caregiver available to receive education and participate on their behalf.
- Severe visual impairment or inability to comprehend Chinese text and pictorial materials.
- Refusal to sign the written informed consent form despite meeting the inclusion criteria.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Experimental Group
Receives routine discharge planning supplemented with the structured respiratory assistive device health education manual.
Behavioral: Structured Discharge Educational Manual for Respiratory Assistive Devices
Control Group
Receives routine discharge planning services, including standard oral education and device instructions.
Other: Routine Discharge Planning Service
Structured Discharge Educational Manual for Respiratory Assistive Devices BEHAVIORAL
In addition to routine discharge planning, participants receive a structured, pictorial educational manual developed by the Division of Thoracic Medicine at Fu Jen Catholic University Hospital.
The manual comprises four structured modules:
1. Patient triage for home mechanical ventilation, discharge planning workflow, respiratory assistive devices introduction, and operational precautions;
2. Verification of eligibility and application procedures for medical assistive device subsidies provided by the New Taipei City Department of Health;
3. Relevant information and documentation preparation for home respiratory care institutions for ventilator-dependent cases; and
4. Long-term Care 2.0 application procedures and service introduction for eligible participants.
Routine Discharge Planning Service OTHER
Participants receive conventional hospital discharge planning care delivered by a discharge planning respiratory therapist. This includes verbal education, individual patient care need assessment, and standard operational guidance on prescribed respiratory assistive devices.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Readiness for Hospital Discharge Scale (RHDS) Score
Time frame: 1 day prior to hospital discharge
Assessed using the Chinese version of the Readiness for Hospital Discharge Scale (RHDS). The scale consists of 23 items across four dimensions: personal status, knowledge, coping ability, and expected support. Item 1 is a dichotomous question ("Yes/No") regarding readiness for discharge, while the remaining 22 items are rated on an 11-point numeric scale ranging from 0 to 10 (with Items 3 and 6 reverse-scored). Higher total scores indicate a higher level of readiness for hospital discharge.
Secondary measures
Home Readiness Score for Respiratory Assistive Devices
Time frame: 1 week after hospital discharge
Measured using the Home Readiness Questionnaire for Respiratory Assistive Devices developed by the research team. It assesses 11 items covering three domains: equipment and service satisfaction, device knowledge and operation, and alarm management/emergency handling. Items are scored on a 5-point Likert scale (1 = very dissatisfied/unable to perform to 5 = very satisfied/independent). The final score is calculated as a percentage: 70-100% indicates excellent readiness, 40-69% indicates adequate readiness, and 0-39% indicates high risk requiring re-education.
Assistive Technology Satisfaction Score (T-QUEST 2.0)
Time frame: 1 week after hospital discharge
Evaluated using the Taiwanese version of the Quebec User Evaluation of Satisfaction with Assistive Technology (T-QUEST 2.0). The scale includes 8 items assessing satisfaction with the assistive device itself and 5 items evaluating satisfaction with related services, providing a comprehensive assessment of patient satisfaction with home respiratory assistive technology.
Utilization Rate of Respiratory Assistive Devices
Time frame: 1 week after hospital discharge
The proportion (percentage) of participants who consistently use the prescribed home respiratory assistive devices (e.g., oxygen therapy, nebulizers, suction units, or non-invasive ventilators) as instructed, assessed via telephone follow-up.
Hospital Readmission Rate
Time frame: At 7 days and 30 days post-discharge
The percentage of participants who experience an unplanned all-cause hospital readmission following index discharge.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Fu Jen Catholic University Hospital
- Study start
- Nov 9, 2026 Estimated
- Primary completion
- Jul 31, 2027 Estimated
- Study completion
- Jul 31, 2027 Estimated
- First posted
- Sep 29, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
The Effects of a Respiratory Assistive Device Health Education Manual on Readmission Rates and Self-Care Efficacy: A Randomized Controlled Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
