Patient-Centered Education After Hip Fracture Surgery (PCE-HFS)
5. september 2026 oppdatert av: Asmaa Edrees Fathallah Edrees, Assiut University
Effect of a Structured Patient-Centered Educational Program on Postoperative Outcomes Following Hip Fracture Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of a structured patient-centered educational program on postoperative outcomes among patients undergoing hip fracture surgery.
Participants will be randomly assigned to either an intervention group receiving the educational program in addition to routine care or a control group receiving routine care only.
The study will assess whether the educational program improves postoperative recovery, functional independence, and pain outcomes following hip fracture surgery.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Hip fracture is a major cause of disability, functional decline, and increased healthcare utilization among older adults.
This study is a parallel-group randomized controlled trial conducted at the Orthopedic Department and Orthopedic Outpatient Clinics of Qena University Hospital.
Participants will be randomly allocated in a 1:1 ratio to either an intervention group receiving a structured patient-centered educational program in addition to routine postoperative care or a control group receiving routine postoperative care alone.
Randomization will be performed using computer-generated random numbers with allocation concealment using sealed opaque envelopes, and outcome assessment will be conducted by a blinded assessor.
The educational program includes education on postoperative care, pain management, safe mobility, rehabilitation exercises, activities of daily living, prevention of postoperative complications, and discharge planning, supported by an illustrated educational booklet.
Participants will be followed from the preoperative assessment through hospital discharge and scheduled postoperative follow-up visits.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Aamaa Edrees Fathallah, MSCN
- Telefonnummer: +21020910362
- E-post: asmaa.edress0986@nursing.aun.edu.eg
Studiesteder
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Qena Governorate
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Qina, Qena Governorate, Egypt
- Rekruttering
- Qena University Hospital
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Ta kontakt med:
- Asmaa Edrees Fatahallah
- Telefonnummer: +201020910362
- E-post: asmaa.edress0986@nursing.aun.edu.eg
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Ta kontakt med:
- E-post: asmaaedrees782@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Patients undergoing hip fracture surgery.
- Medically stable and able to participate in the educational program.
- Able to understand study instructions and provide written informed consent.
Exclusion Criteria:
- Cognitive impairment that prevents participation (e.g., dementia).
- Severe comorbidities that significantly limit mobility.
- Discharged before completion of the educational program.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention Group
Participants in this group will receive a structured patient-centered educational program in addition to routine postoperative care.
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A structured educational program focusing on postoperative care, pain management, rehabilitation exercises, safe mobility, prevention of complications, and activities of daily living, supported by an illustrated educational booklet.
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Ingen inngripen: Control Group
Participants in this group will receive routine postoperative care only.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Independence Measure (FIM) Total Score.
Tidsramme: Baseline (preoperative), at hospital discharge (assessed up to 4 days after surgery), 1 month after surgery, and 3 months after surgery.
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The Functional Independence Measure (FIM) will be used to assess functional independence following hip fracture surgery.
The FIM consists of 18 items with a total score ranging from 18 to 126.
Higher scores indicate greater functional independence and better postoperative functional outcomes.
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Baseline (preoperative), at hospital discharge (assessed up to 4 days after surgery), 1 month after surgery, and 3 months after surgery.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analog Scale (VAS) Pain Score.
Tidsramme: Baseline (preoperative), at hospital discharge (assessed up to 4 days after surgery), 1 month after surgery, and 3 months after surgery.
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Pain intensity will be assessed using the Visual Analog Scale (VAS).
The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline (preoperative), at hospital discharge (assessed up to 4 days after surgery), 1 month after surgery, and 3 months after surgery.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Samia Youssef Sayed, Prof, Faculty of Nursing, Assiut University
- Studiestol: Rasha Ali Ahmed Abdelmowla, Prof, Faculty of Nursing, Assiut University
- Studiestol: Hamdy Ahmed Hussein Tammam, Asst. Prof, Faculty of Medicine, South Valley University, Qena
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. september 2026
Primær fullføring (Antatt)
5. februar 2027
Studiet fullført (Antatt)
1. desember 2027
Datoer for studieregistrering
Først innsendt
9. juli 2026
Først innsendt som oppfylte QC-kriteriene
29. juli 2026
Først lagt ut (Faktiske)
31. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1120261454
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
IPD will not be shared with other researchers.
Participant data will remain confidential and will only be used for the purposes of this study in accordance with ethical research principles and institutional regulations.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .