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

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

Daily life after stroke in elderly people. Evaluation of stroke unit care focusing on daily activities, resource use and costs, assistive devices and health-related quality of life

Aims: The overall aims of this thesis were: a) to compare stroke unit (SU) care and its continuum with care on general wards (GW) for elderly patients, concerning resource use and costs for care and rehabilitation focusing on assistive technology in a one-year follow-up and, b) to explore the use and cost of assistive devices (ADs), ability in daily activities and self-rated health-related quality of life (HRQL) longitudinally.Methods: Two hundred and forty-nine persons &gt;70 years were followed in a randomized, prospective study evaluating SU care after acute stroke. The patients were interviewed and observed four times during the first year by two registered occupational therapists. In two of the studies the patients were followed longitudinally.Results: There were no statistically significant differences in total resource use and costs for care and rehabilitation between the SUs and the GWs during the first year after acute stroke. Costs in relation to the severity at stroke onset showed statistically significant differences, indicating that patients with severe stroke were treated at a higher cost.Informal care widely exceeded the care provided by the community.The total cost of ADs was 2% of the total costs of care and rehabilitation during the first year. One third of the patients had ADs before stroke. After one year the majority of the patients with stroke used ADs. There was a statistically significant difference between the SU group and the GW group in the proportion of patients who had supplementary ADs prescribed between 0-3 months after stroke; the patients at the SU had a higher number of uncomplicated and cheap ADs prescribed. The ADs had a large impact and were prescribed at low cost. Different types of ADs were needed at different stages in the rehabilitation process. Constant routine evaluation of elderly patients with stroke is recommended during the first year after stroke.High concordance was found between the assessments in the Functional Independence Measure (FIMTM) and the Barthel Index (BI). The assessments in the 7-level FIMTM polarize, and the intermediary levels are rarely used, suggesting that a 5-level FIM is sufficient.There were no statistically significant differences between the SU group and the GW group regarding dependence or HRQL as assessed longitudinally. There were statistically significant differences in daily activities and HRQL as assessed with the 5-level FIM and the Nottingham Health Profile (NHP) in patients who used at least one AD and those who did not.Conclusions: Since the majority of the patients with stroke used ADs one year after acute stroke but at relatively low cost, assistive technology must be considered to be one of the best tools for maintaining the highest possible level of daily activity in this patient group. Regular routine evaluations are required both for best use of resources and adaptation to individual needs. The 5-level FIM proved to be useful, but further research into its clinical utility is required. More attention should be paid to the role of spouses as caregivers in stroke survivors, since informal care carries a far greater burden than the care provided by the community. Support schemes of all types are required to relieve the spouse