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

Abstract

BackgroundThe 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/DesignThe 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).DiscussionWe 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 registrationClinicalTrials.gov, NCT00877058

Positive effects on life satisfaction following health-promoting interventions for frail older adults: a randomized controlled study

“…17,19 Our results are in accordance with the findings of Enkvist et al, who found that life satisfaction remained on a high level for those whose functional capacity remained independent during a 3-year follow up. 30 Both interventions were designed for promoting health and coping with effects of the aging process, 11 especially the intervention with senior meetings aimed at giving tools and Article Table 3. Proportion and odds ratios for being satisfied at baseline and follow-ups, (95% confidence interval, CI).…”

“…The study was performed between November 2007 and May 2011, and has been described in detail elsewhere. 11 The study adheres to the CONSORT statement to report randomized controlled and pragmatic trials. 22,23 …”

“…The proportion of the different frailty indicators shows that the participants experiences different degrees for frailty, with approximately 40% reporting fatigue, 60% visual impairment and about 30% low level of physical activity, giving a sample that can be seen as representative of a pre-frail population of older adults. 11 So far the differences between the two interventions -preventive home visit and senior meetings -have been small and insignificant. Thus, it is not yet possible to determine if one intervention is superior to the other, or if individual characteristics of the older adults influence the outcome.…”

“…Study protocol meetings for research assistants were held throughout the study to enhance the quality of outcome measurements. 11 Sample size, randomization and blinding A power calculation was made based on the assumption that the control group would further deteriorate by 20%, and the intervention group preventive home visit 15% more than the intervention group senior meetings. With a significance level of alpha=0.05 and a power of 80%, at least 112 persons were required in each intervention group and 72 in the control group (two-sided test), giving a required total sample of 300; 459 persons were included in the study.…”

“…10 In 2008, the three-armed health-promoting intervention study, Elderly Persons in the Risk Zone was set up, addressing the very old (age 80+) persons that are on the point of developing frailty, pre-frail. 11 The study evaluates the effects of two interventions: i) a preventive home visit and, ii) multi-professional senior group meetings with one follow-up visit. The effects have thus far proven to be positive: there was a postponement in dependence in activities of daily living for the participants in the senior meetings and both interventions delayed the deterioration in self-rated health at the three-month follow-up.…”