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.
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
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).


CONCLUSIONS
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.
Dahlin-Ivanoff
Synneve
S
Vårdalinstitutet, The Swedish Institute for Health Sciences, Universities of Gothenburg and Lund, Sweden. Synneve.Dahlin-Ivanoff@gu.se
Gosman-Hedström
Gunilla
G
Edberg
Anna-Karin
AK
Wilhelmson
Katarina
K
Eklund
Kajsa
K
Duner
Anna
A
Ziden
Lena
L
Welmer
Anna-Karin
AK
Landahl
Sten
S
D000203:Activities of Daily Living; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D016330:Frail Elderly; D006293:Health Promotion / Q000379:methods* / Q000639:trends; D006699:Home Care Services; D006801:Humans; D008297:Male; D010353:Patient Education as Topic / Q000379:methods* / Q000639:trends; D012307:Risk Factors; D016037:Single-Blind Method