Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT07848087
Not yet recruitingNCT07848087ClinicalTrials.gov record

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

THE QUICK READ

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.
Understand screening

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.

Prepare your questions

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

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

CHUN YING HUANG, B.S., RTCONTACTc03635@mail.fjuh.fju.edu.tw+886-85128888 #23423
Official study title

The Effects of a Respiratory Assistive Device Health Education Manual on Readmission Rates and Self-Care Efficacy: A Randomized Controlled Trial

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

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