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

Not Applicable

Completed

• Conditions: Quality of Life; Hip Fractures

• Registration Number: NCT04650360
• Lead Sponsor: University of Extremadura

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.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2017-07-31
• Study Completion: 2018-08-15
• Status Verified: 2020-11
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-24
• Last Update Submitted: 2020-11-24
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life assesment by	12 months	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

Name	Time	Method
Functional dependence (basic activities of daily living )assesment by	12 months	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

Trial Locations

Locations (1)

Sergio Rico Martin; 🇪🇸 Cáceres, Spain