The Chaos Clinic for prevention of falls and related injuries: a randomised, controlled trial
| ISRCTN | ISRCTN48015966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48015966 |
| Protocol serial number | 128 |
| Sponsor | The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland) |
| Funders | This study is partly internally funded by the principal research organisation, the Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)., The Medical Research Fund of Tampere University Hospital (Finland), The Finnish Ministry of Social Affairs and Health (Finland), The State Provincial Office of Western Finland (Finland), City of Tampere (Finland), State Provincial Office of Southern Finland (Finland), City of Lappeenranta (Finland), Lappeenranta Service Centre Foundation (Finland), Juho Vainio Foundation (Finland) |
- Submission date
- 09/05/2007
- Registration date
- 08/06/2007
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mika Palvanen
Scientific
Scientific
The UKK Institute
PO Box 30
Tampere
FIN-33501
Finland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | This is a pragmatic, randomised controlled study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | The Chaos Clinic for prevention of falls and related injuries: a randomised, controlled trial |
| Study acronym | KAAOS (Kaatumis-ja osteoporoosiklinikka [The Chaos Clinic]) |
| Study objectives | Falls are the most common accidents in elderly people. Around 30% of people aged 65 years or older living in the community fall every year. In Finland, annually more than 1000 people die after a fall-induced injury. This is three times more than the number of victims in traffic accidents. The number of hip fractures has increased over threefold during last three decades and the same trend can be seen in the number and incidence of many other osteoporotic fractures, too. If preventive measures are not urgently adopted these numbers will continue to rise. Falls and fractures have several independent risk factors and many studies have shown that it is difficult to prevent these accidents by concentrating only to one or few of these factors (single-intervention strategy). In this study, the main purpose is to prevent falls and fall-related injuries (fractures) by concentrating to high-risk individuals and by intervening all the individual risk factors at the same time (multi-factorial preventive approach). At the Chaos Clinic, the elderly participants are first interviewed and examined very carefully and comprehensively to find out the individual risk factors for falls and injuries. There are three professionals at the Chaos Clinic: a nurse who takes care of the interview, a physical therapist who do the tests of mobility, balance and strength, and a physician who do the medical check-up. The effectiveness of the Chaos Clinic will be studied in this randomised controlled trial. The project will continue for many years finally aiming to answer the following questions: 1. Can the Chaos Clinic decrease falls and fall-related injuries among home-dwelling fall-prone elderly people, and if so, how well and what kind of injuries (fractures) can be prevented? 2. Does the clinic show positive effects in the mobility, function, activities of daily living, or quality of life of the target population? 3. If effective, what is the cost-effectiveness of the Chaos Clinic system? Our hypothesis is that the older adults who belong to the Chaos Clinic falls prevention program (intervention group) will have 30% less falls and fall-related injuries than participants in the control group. |
| Ethics approval(s) | This study has been approved by the ethics committee of Pirkanmaa Hospital District on the 18th November 2003 (ref [ETL-code]: R03161). |
| Health condition(s) or problem(s) studied | Falls and related injuries |
| Intervention | So far, the Chaos Clinic study has been a national trial only. Currently (year 2007), Finland has two Chaos Clinics (Tampere and Lappeenranta) and negotiations to start the clinic action in other places (or countries) as well are very lively. Since the Clinics are in every aspect identical, new clinics can be included in the trial. The Clinic has a multidisciplinary approach to evaluate and treat individual intrinsic and extrinsic risk factors for falls and fall-induced injuries such as fractures. Home-dwelling elderly people with a high-risk for falling are first interviewed and examined at the Chaos Clinic by a physiotherapist, nurse and physician. After comprehensive and individual assessment of the risk factors for falling, the participants are randomised to the intervention group and control group. Thereafter, the personnel of the Chaos Clinic decide, on individual basis, the preventive measures needed and supervise their execution in the intervention group. The other half of the participants or the control group receives general injury prevention guidelines only. Control: The control group receives general injury prevention guidelines in the form of a brochure made by the Finnish Campaign called Prevention of Home Accidents (Kotitapaturmien ehkäisykampanja). Intervention: In addition, the participants in study group receive all the individual preventive measures judged necessary at the baseline assessment. The personnel of the Chaos Clinic supervise the execution of the intervention measures. These measures include: 1. General guidance for physical activity (physical activity prescription) 2. Guidance for adequate nutrition (calcium and vitamin D supplementation) 3. Individually tailored or group training of strength and balance (led by a professional exercise leader) 4. Treatment of illnesses increasing the risk of falling 5. Review of medications (withdrawal of redundant psychotropic medication) 6. Alcohol use reduction, if necessary 7. Request to stop smoking, if necessary 8. Recommendation for the use of hip protectors, if necessary 9. Specific treatment of osteoporosis, if necessary 10. Home hazard assessment and modification In both groups, the number of falls and fall-related injuries are recorded for 12 months, by phone interview at 3 and 9 months, and, at a follow-up visit at 6 and 12 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Falls and fall-related injuries, especially fractures. These will be measured every three months i.e. by phone calls at 3 and 9 months, and on follow-up visits at 6 and 12 months from the beginning. |
| Key secondary outcome measure(s) |
1. Mobility, function, and activities of daily living (Guralnik-test, Timed Up and Go [TUG]-test, and tests for reaction time, balance, and muscle strength) |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 3200 |
| Total final enrolment | 1314 |
| Key inclusion criteria | All home-dwelling persons aged 70 years or more with high-risk for falling and fall-induced injuries and fractures are eligible and belong to the target group. Primarily, such individuals are guided to the Chaos Clinic by the regional health care professionals (physicians, nurses, physical therapists) but relatives and older adults by themselves can also contact the Clinic for assessment of the eligibility. Inclusion criteria Age: 70 years or more, with at least one of the following criteria: a. Problems in mobility and everyday function b. Three or more falls in the last 12 months c. Previous fracture after the age 50 d. Osteoporotic fracture (hip fracture) in a close relative (mother or dad) e. Osteoporosis; clinically proved or strong suspicion f. Low body weight (Body Mass Index [BMI] less than 19) g. Sickness/illness essentially increasing the risk for osteoporosis, falls or fractures |
| Key exclusion criteria | Person's inability to give informed consent (for example, because of dementia or handicap) is a contraindication to be included in the study. Other exclusion criteria are: 1. Disabilities or illnesses preventing physical activity and training 2. Inability to move (bedridden individuals) 3. Terminal illness (predicted lifetime less than 12 months) |
| Date of first enrolment | 17/01/2005 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Finland
Study participating centre
The UKK Institute
Tampere
FIN-33501
Finland
FIN-33501
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2014 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.
