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Completed

NCT Number: NCT04650360

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.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Quality of Life Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sergio Rico Martin

Cáceres, 10001, Spain

About this study

This study will be perform by Spanish nurses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative Intervention Educational Program

Behavioral

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 outcomes

  1. Quality of life assesment by

    Time frame: 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 outcomes

  1. Functional dependence (basic activities of daily living )assesment by

    Time frame: 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

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Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 2, 2020
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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