Fall Prevention Among Community Living Elderly

Accidental Falls/Prevention and Control Clinical Trial

Official title:

Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705912
• Other study ID #: OLLGF01
• Secondary ID: OLLGF0112
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: October 11, 2012
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2012
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess effects of a home exercise program, supervised by assistant nurses with the aim of preventing falls.

Community living persons 65 years of age or older having a risk of falling were invited to participate. Participants were randomized to either training or control.

The training program was individually designed by a physiotherapist and the 5-month program performance was supervised in the partcipants home by eight home visits from an assistant nurse.

All participants received a visit from an occupational therapist who assessed the home and, if necessary, gave advice.

Description:

Falls among elderly are a major public health problem, but preventive interventions containing physical exercise and home improvement are available.

In this study the crucial question was to test whether unlicensed staff, assistant nurses, could be used for preventive work.

Estimation of study power gave that 170 participants in each group would be needed to detect a difference in days with falls, the main outcome measure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• community living persons at least 65 years old

• independent walking ability with or without walking aid

• experienced at least one fall during the last 12 months

• ability to communicate and cooperate with study staff

Exclusion Criteria:

• ongoing physiotherapy treatment

• ongoing participation in exercise/acitivity containing balance and strength enhancing components

• a dementia diagnose

• mental disorder that affects possibility to communicate and cooperate

• other medical reason making participation inte the study inappropriate.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Accidental Falls/Prevention and Control

Intervention

Other:
• Complete intervention
The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.
• Basic intervention
The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.

Locations

Country	Name	City	State
Sweden	Family medicine research center	Orebro

Sponsors (3)

Lead Sponsor	Collaborator
Gunilla Fahlstrom	Örebro County Council, Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Strength	Chair stand test	Pre and post intervention, 5 months	No
Other	Balance	Falls efficacy scale (FES)	Pre and post intervention, 5 months	No
Other	Balance	Bergs balance scale	Pre and post intervention, 5 months	No
Other	Walking 3 metres test		Pre and post intervention, 5 months	No
Other	Health related quality of life	Self reported interview data, SF-36	Pre and post intervention, 5 months	No
Other	Activities of daily living	ADL	Pre and post intervention, 5 months	No
Other	Walking	Minutes of walking per day, self reported calendar data.	12 months	No
Other	Hospital days	Hospital register data	12 months	No
Other	Hospital visits	Hospital register data	12 months	No
Other	Fractures or other harms	Hospital register data	12 months	No
Other	Strength	Timed Up and Go, TUG	Pre and post assessment, 5 months	No
Primary	Number of days with fall	Self reported calendar data	12 months	No
Secondary	Exercise	Self reported calendar data	12 months	No