Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2010 May 26:10:27.
doi: 10.1186/1471-2318-10-27.

Elderly persons in the risk zone. Design of a multidimensional, health-promoting, randomised three-armed controlled trial for "prefrail" people of 80+ years living at home

Synneve Dahlin-Ivanoff  1 , Gunilla Gosman-Hedström, Anna-Karin Edberg, Katarina Wilhelmson, Kajsa Eklund, Anna Duner, Lena Ziden, Anna-Karin Welmer, Sten Landahl
Affiliations
Randomized Controlled Trial

Elderly persons in the risk zone. Design of a multidimensional, health-promoting, randomised three-armed controlled trial for "prefrail" people of 80+ years living at home

Synneve Dahlin-Ivanoff et al. BMC Geriatr. .

Abstract

Background: The very old (80+) are often described as a "frail" group that is particularly exposed to diseases and functional disability. They are at great risk of losing the ability to manage their activities of daily living independently. A health-promoting intervention programme might prevent or delay dependence in activities of daily life and the development of functional decline. Studies have shown that those who benefit most from a health-promoting and disease-preventive programme are persons with no, or discrete, activity restrictions. The three-armed study "Elderly in the risk zone" is designed to evaluate if multi-dimensional and multi-professional educational senior meetings are more effective than preventive home visits, and if it is possible to prevent or delay deterioration if an intervention is made when the persons are not so frail. In this paper the study design, the intervention and the outcome measures as well as the baseline characteristics of the study participants are presented.

Methods/design: The study is a randomised three-armed single-blind controlled trial with follow-ups 3 months, 1 and 2 years. The study group should comprise a representative sample of pre-frail 80-year old persons still living at home in two municipalities of Gothenburg. To allow for drop-outs, it was estimated that a total of about 450 persons would need to be included in the study. The participants should live in their ordinary housing and not be dependent on the municipal home help service or care. Further, they should be independent of help from another person in activities of daily living and be cognitively intact, having a score of 25 or higher as assessed with the Mini Mental State Examination (MMSE).

Discussion: We believe that the design of the study, the randomisation procedure, outcome measurements and the study protocol meetings should ensure the quality of the study. Furthermore, the multi-dimensionality of the intervention, the involvement of both the professionals and the senior citizens in the planning of the intervention should have the potential to effectively target the heterogeneous needs of the elderly.

Trial registration: ClinicalTrials.gov NCT00877058.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow chart. Flowchart throughout enrollment, allocation and baseline.
See this image and copyright information in PMC

References

    1. Ferrucci L, Guralnik JM, Studenski S, Fried LP, Cutler GB Jr, Walston JD. Designing randomized, controlled trials aimed at preventing or delaying functional decline and disability in frail, older persons: a consensus report. J Am Geriatr Soc. 2004;52(4):625–634. doi: 10.1111/j.1532-5415.2004.52174.x. - DOI - PubMed
    1. Gill TM. Education, prevention, and the translation of research into practice. J Am Geriatr Soc. 2005;53(4):724–726. doi: 10.1111/j.1532-5415.2005.53227.x. - DOI - PubMed
    1. Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994;331(13):821–827. doi: 10.1056/NEJM199409293311301. - DOI - PubMed
    1. Vass M, Avlund K, Lauridsen J, Hendriksen C. Feasible model for prevention of functional decline in older people: municipality-randomized, controlled trial. J Am Geriatr Soc. 2005;53(4):563–568. doi: 10.1111/j.1532-5415.2005.53201.x. - DOI - PubMed
    1. Folkhälsa: lägesrapport 2005. http://www.friskanorrbotten.nu/PublishedObjects/10005218/20061317.pdf

Publication types

Associated data