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

• Sponsor: Hospital Galdakao-Usansolo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02802358
• Collaborator: (none)
• Enrollment: 1,824

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Elderly; Wrist Fracture; Hip Fracture	Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)

Study Design

• Study Type: Observational
• Actual Enrollment: 1824 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Sep 1, 2010

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Questionnaires to measure change in the functionality of the elderly [Before and 6 months after the fall]

Secondary Outcome Measures

1. Questionnaire to measure change in the health-related quality of life of the elderly [Before and 6 months after the fall]

2. Questionnaire to measure change in the performance of activities of daily living [Before and 6 months after the fall]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Galdakao-Usansolo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JOSE M QUINTANA-LOPEZ, MD PhD, Dr., Hospital Galdakao-Usansolo
• ClinicalTrials.gov Identifier: NCT02802358
• Other Study ID Numbers: PI08/90417; 2008111016
• First Posted: Jun 16, 2016
• Last Update Posted: Jun 16, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by JOSE M QUINTANA-LOPEZ, MD PhD, Dr., Hospital Galdakao-Usansolo: Falls; Functionality
• Additional relevant MeSH terms: Fractures, Bone; Hip Fractures

Study Results

No Results Posted as of Jun 16, 2016