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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01391728
Other study ID # 20102011
Secondary ID
Status Completed
Phase N/A
First received July 11, 2011
Last updated February 6, 2013
Start date March 2011
Est. completion date November 2012

Study information

Verified date June 2011
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Karolinska Institutet:Stockholm:Sweden
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 65 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)

Exclusion Criteria:

- Cognitive impairments

- Documented psychiatric problems that make participation in organized group activity impossible

- Considerable difficulties in speaking and understanding Swedish

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Behavioral:
Active Lifestyle all your Life
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.

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accidental falls Two Years (2010-2012) Yes
Secondary Participation Self-Rated health Self efficacy Two Years (2010-2012) No
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