- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07739225
Patient-Centered Education After Hip Fracture Surgery (PCE-HFS)
5. september 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Aamaa Edrees Fathallah, MSCN
- Telefonnummer: +21020910362
- E-mail: asmaa.edress0986@nursing.aun.edu.eg
Studiesteder
-
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Qena Governorate
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Qina, Qena Governorate, Egypten
- Rekruttering
- Qena University Hospital
-
Kontakt:
- Asmaa Edrees Fatahallah
- Telefonnummer: +201020910362
- E-mail: asmaa.edress0986@nursing.aun.edu.eg
-
Kontakt:
- E-mail: asmaaedrees782@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group
Participants in this group will receive a structured patient-centered educational program in addition to routine postoperative care.
|
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.
|
|
Ingen indgriben: Control Group
Participants in this group will receive routine postoperative care only.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
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.
|
Baseline (preoperative), at hospital discharge (assessed up to 4 days after surgery), 1 month after surgery, and 3 months after surgery.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- 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
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. september 2026
Primær færdiggørelse (Anslået)
5. februar 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
9. juli 2026
Først indsendt, der opfyldte QC-kriterier
29. juli 2026
Først opslået (Faktiske)
31. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1120261454
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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.
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