Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture

Impact of a Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture

The objective of this study is to determine the impact of a postoperative educational intervention program on the health-related quality of life (HRQoL) of patients with hip fracture using a controlled clinical trial in a randomized, multicenter study. A total of 224 patients will be recruited, 102 patients from trauma units at the two University Hospitals of the province of Cáceres will receive the educational program, whereas 122 will not. Patients will consecutively included in either an intervention or a control group. Patients from the intervention group reill eceive an educational program during admission and the postoperative period. Patients from the control group will not receive any educational program. These patients will manage according to routine protocols.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Hip Fractures
• Intervention / Treatment: Behavioral: Postoperative Intervention Educational Program

Detailed Description

This study will be perform by Spanish nurses.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cáceres, Spain, 10001
    • Sergio Rico Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients over 65 years of age
• Diagnosis of hip fracture
• Previous urgent surgical intervention for surgical fixation of the fracture

Exclusion criteria:

• Cognitive impairment
• Terminal situation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postoperative Intervention Educational Program; The intervention group will receive an educational program during admission. The health educational program will consist of a single training session offered by a nursing professional to each patient and caregiver. In each educational session, the following topics will be addressed: objectives for functional recovery (early mobilization, recovery of functional capacity lost prior to the fracture, etc.), mobilization exercises to start the day after the surgical procedure (lower limb exercise, respiratory physiotherapy, etc.), and tips to prevent future falls	Behavioral: Postoperative Intervention Educational Program; The health educational program consisted of a single training session offered by a nursing professional to each patient and caregiver. In each educational session, the following topics were addressed: objectives for functional recovery (early mobilization, recovery of functional capacity lost prior to the fracture, etc.), mobilization exercises to start the day after the surgical procedure (lower limb exercise, respiratory physiotherapy, etc.), and tips to prevent future falls. The educational session was implemented during the postoperative hospital stay, with an approximate duration of 30-45 min. The session ended with a summary of the content and comments from the patient and relative in order to ensure understanding of the program. Written information was provided on the aspects addressed in the session (brochures). These patients were treated according to routine protocols. All patients were monitored during admission, at 1 month, at 6 months, and at 1 year after the intervention
No Intervention: Control; The patients in the control group will not receive any educational program. These patients will be treated according to routine protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assesment by	SF-12 Health Survey questionnaire which consists of two dimensions (Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12)) that measure eight health domains (PCS: general health, physical function, physical role, and body pain; MCS: social function emotional role, mental health, and vitality) divided into a summary score of the physical component. Each component can be scored from 0 (lowest health) to 100 (highest health).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional dependence (basic activities of daily living )assesment by	Barthel scale for functional dependence analysis. A total score between 0 and 20 suggests total dependence, a total score between 21 and 60 suggests severe dependence, a total score between 61 and 90 suggests moderate dependence, a total score between 91 and 99 suggests mild dependence, and a total score of 100 suggests independence	12 months

Collaborators and Investigators

• Sponsor: University of Extremadura
• Investigators: Principal Investigator: Fidel Lopez Espuela, PhD, Nursing and Occupational Therapy College. University of Extremadura

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PIEP_QLHF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No