Design of a randomized controlled study of a multi-professional and multidimensional intervention targeting frail elderly people

<p>Abstract</p> <p>Background</p> <p>Frail elderly people need an integrated and coordinated care. The two-armed study "Continuum of care for frail elderly people" is a multi-professional and multidimensional intervention for frail community-dwelling elderly people. It was designed to evaluate whether the intervention programme for frail elderly people can reduce the number of visits to hospital, increase satisfaction with health and social care and maintain functional abilities. The implementation process is explored and analysed along with the intervention. In this paper we present the study design, the intervention and the outcome measures as well as the baseline characteristics of the study participants.</p> <p>Methods/design</p> <p>The study is a randomised two-armed controlled trial with follow ups at 3, 6 and 12 months. The study group includes elderly people who sought care at the emergency ward and discharged to their own homes in the community. Inclusion criteria were 80 years and older <it>or </it>65 to 79 years with at least one chronic disease and dependent in at least one activity of daily living. Exclusion criteria were acute severely illness with an immediate need of the assessment and treatment by a physician, severe cognitive impairment and palliative care. The intention was that the study group should comprise a representative sample of frail elderly people at a high risk of future health care consumption. The intervention includes an early geriatric assessment, early family support, a case manager in the community with a multi-professional team and the involvement of the elderly people and their relatives in the planning process.</p> <p>Discussion</p> <p>The design of the study, the randomisation procedure and the protocol meetings were intended to ensure the quality of the study. The implementation of the intervention programme is followed and analysed throughout the whole study, which enables us to generate knowledge on the process of implementing complex interventions. The intervention contributes to early recognition of both the elderly peoples' needs of information, care and rehabilitation and of informal caregivers' need of support and information. This study is expected to show positive effects on frail elderly peoples' health care consumption, functional abilities and satisfaction with health and social care.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01260493">NCT01260493</a></p

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/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, NCT0087705

Three-Armed Trials Including Placebo and No-Treatment Groups May Be Subject to Publication Bias: Systematic Review

Background: It has been argued that placebos may not have important clinical impacts in general. However, there is increasing evidence of a publication bias among trials published in journals. Therefore, we explored the potential for publication bias in randomized trials with active treatment, placebo, and no-treatment groups. Methods: Three-armed randomized trials of acupuncture, acupoint stimulation, and transcutaneous electrical stimulation were obtained from electronic databases. Effect sizes between treatment and placebo groups were calculated for treatment effect, and effect sizes between placebo and no-treatment groups were calculated for placebo effect. All data were then analyzed for publication bias. Results: For the treatment effect, small trials with fewer than 100 patients per arm showed more benefits than large trials with at least 100 patients per arm in acupuncture and acupoint stimulation. For the placebo effect, no differences were found between large and small trials. Further analyses showed that the treatment effect in acupuncture and acupoint stimulation may be subject to publication bias because study design and any known factors of heterogeneity were not associated with the small study effects. In the simulation, the magnitude of the placebo effect was smaller than that calculated after considering publication bias. Conclusions: Randomized three-armed trials, which are necessary for estimating the placebo effect, may be subject t

Influence of cognition on personal activities of daily living (P-ADL) in the acute phase: The Gothenburg Cognitive Stroke Study in Elderly.

This study examines how prestroke dementia and cognitive dysfunction after stroke influence the personal activities of daily living (P-ADL) in elderly patients in the acute phase after stroke. Elderly stroke patients (n=60) referred to geriatric rehabilitation were included. Assessments were carried out at admission and evaluated at discharge from the geriatric ward. The median age of the group was 77 years. Astrand's questionnaire was used to interview a close relative about the patient's prestroke cognitive status. P-ADL was assessed with the Barthel Index (BI). The Mini Mental State Examination (MMSE) and a neuropsychological test battery were used to measure cognitive functions. Analyses were made using non-parametrical methods. In the acute phase after stroke, neither the presence of prestroke dementia nor the cognitive status after stroke onset among these elderly patients influenced P-ADL at admission or at discharge. Prestroke dementia and cognitive dysfunction's were found to be common after stroke onset, however this did not have any impact on dependence in P-ADL in these elderly patients at admission or at discharge

Health-promoting interventions for persons aged 80 and older are successful in the short term-results from the randomized and three-armed Elderly Persons in the Risk Zone study

Objectives: To examine the outcomes of the Elderly Persons in the Risk Zone study, which was designed to evaluate whether it is possible to delay deterioration if a health-promoting intervention is made when an older adult (=80) is at risk of becoming frail and whether a multiprofessional group intervention is more effective in delaying deterioration than a single preventive home visit with regard to frailty, self-rated health, and activities of daily living (ADLs) at 3-month follow-up. Design: Randomized, three-armed, single-blind, controlled trial performed between November 2007 and May 2011. Setting: Two urban districts of Gothenburg, Sweden. Participants: Four hundred fifty-nine community-living adults aged 80 and older not dependent on the municipal home help service. Intervention: A preventive home visit or four weekly multiprofessional senior group meetings with one follow-up home visit. Measurements: Change in frailty, self-rated health, and ADLs between baseline and 3-month follow-up. Results: Both interventions delayed deterioration of self-rated health (odds ratio (OR) = 1.99, 95% confidence interval (CI) = 1.12–3.54). Senior meetings were the most beneficial intervention for postponing dependence in ADLs (OR = 1.95, 95% CI = 1.14–3.33). No effect on frailty could be demonstrated. Conclusion: Health-promoting interventions made when older adults are at risk of becoming frail can delay deterioration in self-rated health and ADLs in the short term. A multiprofessional group intervention such as the senior meetings described seems to have a greater effect on delaying deterioration in ADLs than a single preventive home visit. Further research is needed to examine the outcome in the long term and in different contexts