Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall

June 13, 2016 updated by: JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo

Objectives: To describe social and health care provided to our older patients who have been admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to a fall. To compare among the different hospitals and town halls, the health and social care that participants received. To compare the functional dependency and health related quality of life (HRQoL) presented by the patients immediately and six months after a fall.

Methodology: Prospective Cohort study. One hundred and fifty patients suffering from each type of fracture (hip or wrist) will be recruited consecutively in the Basque Health System's participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are expected to be collected. Data will be collected from ED and hospital clinical records and by means of questionnaires to measure functional dependency (Barthel and Lawton indexes) and HRQoL (SF-36) requesting information on status before the fall, immediately and six months later. In addition to this, data referred to care provided to the patients by traumatologist, rehabilitation or primary care provider as well as social services in their homes after the index episode will be collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1824

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults aged 65 or older with a hip or wrist fracture due to a fall who attended the ED of the participating hospitals

Description

Inclusion Criteria:

  • Hip or wrist fracture due to an accidental fall.
  • Providing informed consent.

Exclusion Criteria:

  • Physical or psychological impairments that would prevent patients from properly completing the questionnaires.
  • Syncope.
  • No acceptance for taking part in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hip fracture
Patients with a hip fracture due to an accidental fall
Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)
Wrist fracture
Patients with a wrist fracture due to an accidental fall
Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Questionnaires to measure change in the functionality of the elderly
Time Frame: Before and 6 months after the fall
Before and 6 months after the fall

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaire to measure change in the health-related quality of life of the elderly
Time Frame: Before and 6 months after the fall
Before and 6 months after the fall
Questionnaire to measure change in the performance of activities of daily living
Time Frame: Before and 6 months after the fall
Before and 6 months after the fall

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Galdakao-Usansolo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (ESTIMATE)

June 16, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI08/90417
  • 2008111016 (OTHER_GRANT: Department of Health of the Basque Country)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)

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