- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07739225
Patient-Centered Education After Hip Fracture Surgery (PCE-HFS)
July 29, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aamaa Edrees Fathallah, MSCN
- Phone Number: +21020910362
- Email: asmaa.edress0986@nursing.aun.edu.eg
Study Locations
-
-
Qena Governorate
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Qina, Qena Governorate, Egypt
- Qena University Hospital
-
Contact:
- Asmaa Edrees Fatahallah
- Phone Number: +201020910362
- Email: asmaa.edress0986@nursing.aun.edu.eg
-
Contact:
- Email: asmaaedrees782@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
No Intervention: Control Group
Participants in this group will receive routine postoperative care only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Independence Measure (FIM) Total Score.
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) Pain Score.
Time Frame: 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.
|
Baseline (preoperative), at hospital discharge (assessed up to 4 days after surgery), 1 month after surgery, and 3 months after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Samia Youssef Sayed, Prof, Faculty of Nursing, Assiut University
- Study Chair: Rasha Ali Ahmed Abdelmowla, Prof, Faculty of Nursing, Assiut University
- Study Chair: Hamdy Ahmed Hussein Tammam, Asst. Prof, Faculty of Medicine, South Valley University, Qena
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
July 9, 2026
First Submitted That Met QC Criteria
July 29, 2026
First Posted (Actual)
July 31, 2026
Study Record Updates
Last Update Posted (Actual)
July 31, 2026
Last Update Submitted That Met QC Criteria
July 29, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1120261454
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.