Frail Elderly Persons Clinical Trial
Official title:
Elderly Persons at the Risk Zone - a Randomized Controlled Trial of a Community Based Preventive Multiprofessional Program for Old Persons at Risk of Frailty
The present study "Elderly person in the risk zone" form part of the research programme
"Support for frail elderly persons - from prevention to palliation" (www.
Vardalinstitutet.net) which comprises research into three interventions. A fundamental
principle in the research programme is that it comprises interventions addressing frail
elderly person in different phases of the disablement process, from elderly persons who are
beginning to develop frailty to very frail elderly persons receiving palliative care in the
final period of their lives. The interventions also address the different requirements that
arise with regard to professional contributions during the various phases of the ageing and
disease process, ranging from health promotion to a need for an increasing degree of medical
care, nursing, special care and rehabilitation, and finally, efforts that promote symptom
relief, quality of life, security and satisfaction with care during the final period of
life. The intervention "Elderly persons in the risk zone" addresses elderly persons that are
on the point of developing frailty ("pre-frail") and are beginning to feel that they are
being hindered from taking part in everyday activities. The hypothesis is that if an
intervention is made when the persons are not so frail, it is possible to prevent/delay
deterioration.
1. Can a health-promoting and preventive intervention for "prefrail" elderly persons:
- prevent frailty, activity limitations and morbidity,
- be a supportive factor in the social and physical environment,
- affect life satisfaction
- have an impact on the consumption of care
- be cost-effective?
2. How do the frail elderly persons experience the intervention and its importance to
health?
| Status | Completed |
| Enrollment | 459 |
| Est. completion date | May 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 80 Years and older |
| Eligibility |
Inclusion Criteria: - 80 years of age or older living in the community. - The participants should live in their ordinary housing - Independent on formal support - Independent on informal support - Cognitive intact defined as a Mini Mental Test score > 25 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Gothenburg University | Göteborg |
| Lead Sponsor | Collaborator |
|---|---|
| Vardalinstitutet The Swedish Institute for Health Sciences |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dependence in Two or More Activities of Daily Living (ADL) | ADL stair case: Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed |
1 year | No |
| Primary | Number of Partipants Measured Frail at 1-year Follow up | Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition | 1 year | No |
| Primary | Self Rated Health | Self rated health was measured by the question "In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed | 1 year | No |