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

Elderly Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802358
• Other study ID #: PI08/90417
• Secondary ID: 2008111016
• Status: Completed
• Phase: N/A
• First received: June 8, 2016
• Last updated: June 13, 2016
• Start date: June 2009

Study information

• Verified date: June 2016
• Source: Hospital Galdakao-Usansolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1824
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Elderly
• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Wrist Fracture

Intervention

Procedure:
• Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Galdakao-Usansolo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaires to measure change in the functionality of the elderly		Before and 6 months after the fall	Yes
Secondary	Questionnaire to measure change in the health-related quality of life of the elderly		Before and 6 months after the fall	Yes
Secondary	Questionnaire to measure change in the performance of activities of daily living		Before and 6 months after the fall	Yes