NCT01391728

Brief Summary

The purpose of the project is to formulate, implement and evaluate a new type of activity-orientated, evidence-based prevention programme to prevent fall injuries among elderly people. The question examined by the study is whether the intervention programme can:

  • significantly reduce accidents and incidents involving falling among the participants,
  • influence variables such as satisfaction with life, confidence in one's own ability and a feeling of involvement,
  • be shown to be cost effective in terms of the use of resources. The intervention programme - Active lifestyle all your life - is being developed in and for primary care for the cost effective prevention of fall injuries among elderly people using a method that results in continued active life. The aim is to ensure that the elderly person is able to continue living an active life with commitment and involvement, which can in itself prevent fall injuries. This presupposes a knowledge of how to avoid fall injuries and the measures and aids that are available to prevent such injuries. The programme will also provide the participants with a social community in self-supporting groups which, by their own efforts but also with social support, are able to continue some of the activities provided through primary care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 7, 2013

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

July 11, 2011

Last Update Submit

February 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accidental falls

    Two Years (2010-2012)

Secondary Outcomes (1)

  • Participation Self-Rated health Self efficacy

    Two Years (2010-2012)

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR
Behavioral: Active Lifestyle all your Life

Control

NO INTERVENTION

Interventions

Intervention After the first data collection the participants are randomised in an intervention and control group. The control group receives the normal treatment that may be given after a radius fracture and may vary from one care unit to another (but there is no preventive programme within the normal activity as far as we know). In groups of 6-8 participants the intervention group starts the programme "Active lifestyle all your life" with group meetings around every other week (10-12 times) and with 2 individual meetings directed at discussing fall risks in the participant's own home environment. After a summer break, Christmas and New Year three follow-up meetings take place, one of which is an individual meeting. The intervention is then terminated, but the participants are encouraged to continue the activity themselves.

Lifestyle counseling

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • or older
  • Fall injury in the form of radius fracture or other minor documented fall injury, or one or more fall incidents reported in the last six months (reported to a district nurse in the 75-year discussion)

You may not qualify if:

  • Cognitive impairments
  • Documented psychiatric problems that make participation in organized group activity impossible
  • Considerable difficulties in speaking and understanding Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 7, 2013

Record last verified: 2011-06

Locations