search
Back to results

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

Primary Purpose

Hip Fractures, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Postoperative Intervention Educational Program
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sergio Rico Martin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Postoperative Intervention Educational Program

Control

Arm Description

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

The patients in the control group will not receive any educational program. These patients will be treated according to routine protocols

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2020
Last Updated
November 24, 2020
Sponsor
University of Extremadura
search

1. Study Identification

Unique Protocol Identification Number
NCT04650360
Brief Title
Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture
Official Title
Impact of a Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
This study will be perform by Spanish nurses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postoperative Intervention Educational Program
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients in the control group will not receive any educational program. These patients will be treated according to routine protocols
Intervention Type
Behavioral
Intervention Name(s)
Postoperative Intervention Educational Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of life assesment by
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Functional dependence (basic activities of daily living )assesment by
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fidel Lopez Espuela, PhD
Organizational Affiliation
Nursing and Occupational Therapy College. University of Extremadura
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sergio Rico Martin
City
Cáceres
ZIP/Postal Code
10001
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs