Discharge Planning for Patients Requiring Respiratory Assistive DevicesNCT07848087

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

A study testing Structured Discharge Educational Manual for Respiratory Assistive Devices and Routine Discharge Planning Service in people with Discharge Planning for Patients Requiring Respiratory Assistive Devices, run by Fu Jen Catholic University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Discharge Planning for Patients Requiring Respiratory Assistive Devices
What is being tested?: Structured Discharge Educational Manual for Respiratory Assistive Devices and Routine Discharge Planning Service
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: 15 Sep 2026to 31 Jul 2027
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

CHUN YING HUANG, B.S., RT contact

+886-85128888 ext. #23423

c03635@mail.fjuh.fju.edu.tw

About this study

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.

Conditions: Discharge Planning for Patients Requiring Respiratory Assistive Devices
Being tested: Structured Discharge Educational Manual for Respiratory Assistive Devices, Routine Discharge Planning Service
Keywords: Respiratory Assistive Devices, Health Education Manual, Readmission Rate, Readiness for Hospital Discharge.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Structured Discharge Educational Manual for Respiratory Assistive DevicesBehavioural
Also called Pictorial Discharge Planning Manual for Home Respiratory Care
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 ServiceOther
Also called Standard Discharge Care
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.

Study groups in NCT07848087
Study group	Role	What they receive
Experimental Group	Experimental	Receives routine discharge planning supplemented with the structured respiratory assistive device health education manual. Receives: Behavioral: Structured Discharge Educational Manual for Respiratory Assistive Devices
Control Group	Active comparator	Receives routine discharge planning services, including standard oral education and device instructions. Receives: Other: Routine Discharge Planning Service

What is being measured

The primary outcome is the main question the study is designed to answer.

Readiness for Hospital Discharge Scale (RHDS) Score
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.
Measured: 1 day prior to hospital discharge

Secondary outcomes (4)

Home Readiness Score for Respiratory Assistive Devices
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.
Measured: 1 week after hospital discharge
Assistive Technology Satisfaction Score (T-QUEST 2.0)
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.
Measured: 1 week after hospital discharge
Utilization Rate of Respiratory Assistive Devices
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.
Measured: 1 week after hospital discharge
Hospital Readmission Rate
The percentage of participants who experience an unplanned all-cause hospital readmission following index discharge.
Measured: At 7 days and 30 days post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202631 Jul 2027

First posted29 Sep 2026
Study start15 Sep 2026 (estimated)
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Discharge Planning for Patients Requiring Respiratory Assistive DevicesStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07848087
Sponsor's protocol ID: FJUH115608
Status last verified: Sep 2026
First submitted: 23 Sep 2026
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Morton K, Sanderson E, Dixon P, King A, Jenkins S, MacNeill SJ, Shaw A, Metcalfe C, Chalder M, Hollingworth W, Benger J, Calvert J, Purdy S. Care bundles to reduce re-admissions for patients with chronic obstructive pulmonary disease: a mixed-methods study. Southampton (UK): NIHR Journals Library; 2019 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK541984/
PubMed 31194314
Ducic Y. Intraoperative Free Flap Monitoring Using Indocyanine Green. JAMA Facial Plast Surg. 2015 Nov-Dec;17(6):427. doi: 10.1001/jamafacial.2015.1060. No abstract available.
PubMed 26335198
Klein DJ. Vector representations of kekule structures of benzenoids. Acta Chim Slov. 2010 Sep;57(3):591-6.
PubMed 24061805
Boyle PA, Wilson RS, Yu L, Barr AM, Honer WG, Schneider JA, Bennett DA. Much of late life cognitive decline is not due to common neurodegenerative pathologies. Ann Neurol. 2013 Sep;74(3):478-89. doi: 10.1002/ana.23964. Epub 2013 Jul 10.
PubMed 23798485
Bajorek SA, McElroy V. Discharge Planning and Transitions of Care. AHRQ Patient Safety Network. March 25, 2020.
Flaster R. Four strategies cut newborn readmissions. Contemporary Pediatrics. 2017;34(7):10.
Hong LP, Tseng MC. A survey on satisfaction and utilization of assistive mobility technology: A case study of borrowers in Kaohsiung Special Education Resource Center. Educational Studies. 2015;(34):121-183.
Chang MC, Jeng YC, Leu GY, Chang SC. Suitability assessment of printed health education materials for pediatric care. Tzu Chi Nursing Journal. 2015;14(4):58-68.
Lin YH, Kao CC, Huang AM, Chi MT, Chou FH. [Psychometric testing of the chinese version of the readiness for hospital discharge scale]. Hu Li Za Zhi. 2014 Aug;61(4):56-65. doi: 10.6224/JN.61.4.56. Chinese.
PubMed 25116315
National Development Council. Population Projections for the R.O.C. (Taiwan): 2022-2070. National Development Council; 2022.
Ministry of the Interior, Department of Household Registration. Demographic statistics analysis for December 2025. Ministry of the Interior Global Information Website; 2026.
Wilkinson T. Understanding disease mechanisms at the nanoscale: endothelial apoptosis and microparticles in COPD. Thorax. 2016 Dec;71(12):1078-1079. doi: 10.1136/thoraxjnl-2016-208993. Epub 2016 Sep 26. No abstract available.
PubMed 27672115
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
PubMed 12558354
Gemelli N, Las Heras M, San Roman E. Barium Aspiration After Esophagography. Arch Bronconeumol (Engl Ed). 2020 Feb 13:S0300-2896(20)30027-2. doi: 10.1016/j.arbres.2019.12.036. Online ahead of print. No abstract available. English, Spanish.
PubMed 32063391
Ho CCY, Ng MSN, Choi KC, Chan CWH. Effect of pictorial action plan on self-management in older patients with chronic obstructive pulmonary disease: Randomised controlled trial. Geriatr Nurs. 2025 May-Jun;63:231-237. doi: 10.1016/j.gerinurse.2025.03.044. Epub 2025 Apr 9.
PubMed 40209600

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of a Respiratory Assistive Device Health Education Manual on Readmission Rates and Self-Care Efficacy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07848087
Acronym / sponsor ID: FJUH115608
Conditions: Discharge Planning for Patients Requiring Respiratory Assistive Devices
Keywords: Respiratory Assistive Devices, Health Education Manual, Readmission Rate, Readiness for Hospital Discharge.
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Fu Jen Catholic University HospitalUniversity, hospital or other
Study start: 15 Sep 2026 (estimated)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Jul 2027 (estimated)
First posted: 29 Sep 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.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental Group	Experimental	Behavioral: Structured Discharge Educational Manual for Respiratory Assistive DevicesReceives routine discharge planning supplemented with the structured respiratory assistive device health education manual.
Control Group	Active comparator	Other: Routine Discharge Planning ServiceReceives routine discharge planning services, including standard oral education and device instructions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (4 listed)

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.

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
Structured Discharge Educational Manual for Respiratory Assistive DevicesAlso: Pictorial Discharge Planning Manual for Home Respiratory CareIn 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.	Behavioural	Experimental Group
Routine Discharge Planning ServiceAlso: Standard Discharge CareParticipants 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.	Other	Control Group

Primary outcome

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.

4 secondary outcomes

Home Readiness Score for Respiratory Assistive Devices
Time frame: 1 week after hospital discharge
Assistive Technology Satisfaction Score (T-QUEST 2.0)
Time frame: 1 week after hospital discharge
Utilization Rate of Respiratory Assistive Devices
Time frame: 1 week after hospital discharge
Hospital Readmission Rate
Time frame: At 7 days and 30 days post-discharge

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 29 Sep 2026.
Results publication: PubMed 31194314Morton K, Sanderson E, Dixon P, King A, Jenkins S, MacNeill SJ, Shaw A, Metcalfe C, Chalder M, Hollingworth W, Benger J, Calvert J, Purdy S. Care bundles to reduce re-admissions for patients with chronic obstructive pulmonary disease: a mixed-methods study. Southampton (UK): NIHR Journals Library; 2019 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK541984/
Results publication: PubMed 26335198Ducic Y. Intraoperative Free Flap Monitoring Using Indocyanine Green. JAMA Facial Plast Surg. 2015 Nov-Dec;17(6):427. doi: 10.1001/jamafacial.2015.1060. No abstract available.
Results publication: PubMed 24061805Klein DJ. Vector representations of kekule structures of benzenoids. Acta Chim Slov. 2010 Sep;57(3):591-6.
Results publication: PubMed 23798485Boyle PA, Wilson RS, Yu L, Barr AM, Honer WG, Schneider JA, Bennett DA. Much of late life cognitive decline is not due to common neurodegenerative pathologies. Ann Neurol. 2013 Sep;74(3):478-89. doi: 10.1002/ana.23964. Epub 2013 Jul 10.
Results publicationBajorek SA, McElroy V. Discharge Planning and Transitions of Care. AHRQ Patient Safety Network. March 25, 2020.
Results publicationFlaster R. Four strategies cut newborn readmissions. Contemporary Pediatrics. 2017;34(7):10.
Results publicationHong LP, Tseng MC. A survey on satisfaction and utilization of assistive mobility technology: A case study of borrowers in Kaohsiung Special Education Resource Center. Educational Studies. 2015;(34):121-183.
Results publicationChang MC, Jeng YC, Leu GY, Chang SC. Suitability assessment of printed health education materials for pediatric care. Tzu Chi Nursing Journal. 2015;14(4):58-68.
Results publication: PubMed 25116315Lin YH, Kao CC, Huang AM, Chi MT, Chou FH. [Psychometric testing of the chinese version of the readiness for hospital discharge scale]. Hu Li Za Zhi. 2014 Aug;61(4):56-65. doi: 10.6224/JN.61.4.56. Chinese.
Results publicationNational Development Council. Population Projections for the R.O.C. (Taiwan): 2022-2070. National Development Council; 2022.
Results publicationMinistry of the Interior, Department of Household Registration. Demographic statistics analysis for December 2025. Ministry of the Interior Global Information Website; 2026.
Results publication: PubMed 27672115Wilkinson T. Understanding disease mechanisms at the nanoscale: endothelial apoptosis and microparticles in COPD. Thorax. 2016 Dec;71(12):1078-1079. doi: 10.1136/thoraxjnl-2016-208993. Epub 2016 Sep 26. No abstract available.
Individual participant dataSharing planned: Undecided

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.

CHUN YING HUANG, B.S., RT contact

+886-85128888 ext. #23423

c03635@mail.fjuh.fju.edu.tw

Questions about this trial

What is this clinical trial studying?

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 4 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact CHUN YING HUANG, B.S., RT (+886-85128888 ext. #23423, c03635@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Readiness for Hospital Discharge Scale (RHDS) Score (time frame: 1 day prior to hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07848087, which also lists 17 linked publications.

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 29 Sep 2026.