Clinical trial NCT01705912: Fall Prevention Among Community Living Elderly
Official title: Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls/Prevention and Control
Keywords: fall
prevention
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Örebro County Council
name: Örebro University, Sweden
First posted: 2012-10-12
Enrollment: 148
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of days with fall
timeFrame: 12 months
Secondary outcomes:
measure: Exercise
timeFrame: 12 months
Other outcomes:
measure: Strength
timeFrame: Pre and post intervention, 5 months
measure: Balance
timeFrame: Pre and post intervention, 5 months
measure: Balance
timeFrame: Pre and post intervention, 5 months
measure: Walking 3 metres test
timeFrame: Pre and post intervention, 5 months
measure: Health related quality of life
timeFrame: Pre and post intervention, 5 months
measure: Activities of daily living
timeFrame: Pre and post intervention, 5 months
measure: Walking
timeFrame: 12 months
measure: Hospital days
timeFrame: 12 months
measure: Hospital visits
timeFrame: 12 months
measure: Fractures or other harms
timeFrame: 12 months
measure: Strength
timeFrame: Pre and post assessment, 5 months
Locations:
city: Orebro
country: Sweden
facility: Family medicine research center
Study officials:
affiliation: Örebro County Council
name: Gunilla Fahlstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References: