- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07848087
The Effects of a Respiratory Assistive Device Health Education Manual on Readmission Rates and Self-Care Efficacy: A Randomized Controlled Trial
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.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: CHUN YING HUANG, B.S., RT
- Telefonnummer: #23423 +886-85128888
- E-Mail: c03635@mail.fjuh.fju.edu.tw
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Experimental Group
Receives routine discharge planning supplemented with the structured respiratory assistive device health education manual. |
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:
Andere Namen:
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Aktiver Komparator: Control Group
Receives routine discharge planning services, including standard oral education and device instructions. |
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Readiness for Hospital Discharge Scale (RHDS) Score
Zeitfenster: 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. |
1 day prior to hospital discharge
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Home Readiness Score for Respiratory Assistive Devices
Zeitfenster: 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. |
1 week after hospital discharge
|
|
Assistive Technology Satisfaction Score (T-QUEST 2.0)
Zeitfenster: 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. |
1 week after hospital discharge
|
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Utilization Rate of Respiratory Assistive Devices
Zeitfenster: 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. |
1 week after hospital discharge
|
|
Hospital Readmission Rate
Zeitfenster: At 7 days and 30 days post-discharge
|
The percentage of participants who experience an unplanned all-cause hospital readmission following index discharge. |
At 7 days and 30 days post-discharge
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Oh EG, Lee HJ, Yang YL, Kim YM. Effectiveness of Discharge Education With the Teach-Back Method on 30-Day Readmission: A Systematic Review. J Patient Saf. 2021 Jun 1;17(4):305-310. doi: 10.1097/PTS.0000000000000596.
- 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.
- 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/
- 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.
- Klein DJ. Vector representations of kekule structures of benzenoids. Acta Chim Slov. 2010 Sep;57(3):591-6.
- 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.
- 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.
- 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.
- 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.
- 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.
- Jacobs SS, Krishnan JA, Lederer DJ, Ghazipura M, Hossain T, Tan AM, Carlin B, Drummond MB, Ekstrom M, Garvey C, Graney BA, Jackson B, Kallstrom T, Knight SL, Lindell K, Prieto-Centurion V, Renzoni EA, Ryerson CJ, Schneidman A, Swigris J, Upson D, Holland AE. Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Nov 15;202(10):e121-e141. doi: 10.1164/rccm.202009-3608ST.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- FJUH115608
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