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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04650360
Enrollment
224
Registered
2020-12-02
Start date
2015-06-01
Completion date
2018-08-15
Last updated
2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures, Quality of Life

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.

Interventions

BEHAVIORALPostoperative 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

Sponsors

University of Extremadura
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life assesment by12 monthsSF-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

MeasureTime frameDescription
Functional dependence (basic activities of daily living )assesment by12 monthsBarthel 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026