Frequency of Accidental FallsNCT01391728
Active Lifestyle All Your Life-an Intervention Programme for Preventing Fall Injuries
A study testing Active Lifestyle all your Life in people with Frequency of Accidental Falls and Participation, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frequency of Accidental Falls, Participation, Self-rated Health
- What is being tested?
- Active Lifestyle all your Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- Cognitive impairments
- Documented psychiatric problems that make participation in organized group activity impossible
- Considerable difficulties in speaking and understanding Swedish
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Active Lifestyle all your Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Lifestyle all your LifeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | Not described Receives: Behavioral: Active Lifestyle all your Life |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accidental falls
Measured: Two Years (2010-2012)
Secondary outcomes (1)
Participation Self-Rated health Self efficacy
Measured: Two Years (2010-2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frequency of Accidental FallsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391728
- Sponsor's protocol ID
- 20102011
- Status last verified
- Jun 2011
- First submitted
- 11 Jul 2011
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Lifestyle All Your Life-an Intervention Programme for Preventing Fall Injuries
- ClinicalTrials.gov ID
- NCT01391728
- Acronym / sponsor ID
- 20102011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: Active Lifestyle all your Life |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Cognitive impairments
- Documented psychiatric problems that make participation in organized group activity impossible
- Considerable difficulties in speaking and understanding Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Lifestyle all your LifeIntervention 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. | Behavioural | Lifestyle counseling |
Primary outcome
Accidental falls
Time frame: Two Years (2010-2012)
1 secondary outcome
Participation Self-Rated health Self efficacy
Time frame: Two Years (2010-2012)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Lifestyle all your Life in people with Frequency of Accidental Falls and Participation, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accidental falls (time frame: Two Years (2010-2012)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.