Dataset Information

Effectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Frailty is a major concern due to its costly and widespread consequences, yet evidence of effective interventions to delay or reduce frailty is lacking. Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail. Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty. This study describes a randomised controlled trial that aims to evaluate the effectiveness of a multifactorial intervention on development of frailty in older people who are pre-frail.

Methods and analysis

A single centre randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. Two hundred and thirty people aged above 70 who meet the Cardiovascular Health Study frailty criteria for pre-frailty, reside in the community and are without severe cognitive impairment will be recruited. Participants will be randomised to receive a multifactorial intervention or usual care. The intervention group will receive a 12-month interdisciplinary intervention targeting identified characteristics of frailty and problems identified during geriatric assessment. Participants will be followed for a 12-month period. Primary outcome measures will be degree of frailty measured by the number of Cardiovascular Health Study frailty criteria present, and mobility measured with the Short Physical Performance Battery. Secondary outcomes will include measures of mobility, mood and use of health and community services.

Ethics and dissemination

The study was approved by the Northern Sydney Local Health District Health Research Ethics Committee (1207-213M). The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals.

Trial registration number

Australian New Zealand Clinical Trials Registry: ACTRN12613000043730.

SUBMITTER: Fairhall N

PROVIDER: S-EPMC4322196 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: study protocol for a randomised controlled trial.

Fairhall Nicola N Kurrle Susan E SE Sherrington Catherine C Lord Stephen R SR Lockwood Keri K John Beatrice B Monaghan Noeline N Howard Kirsten K Cameron Ian D ID

BMJ open 20150209 2

<h4>Introduction</h4>Frailty is a major concern due to its costly and widespread consequences, yet evidence of effective interventions to delay or reduce frailty is lacking. Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail. Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty. This study describes a randomised controlled trial that aims to evalu ...[more]

PMID: 25667151

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Project description:ObjectivesDizziness is common in older people. Physicians are often unable to identify a specific cause for dizziness in older people, even after an extensive diagnostic work-up. A prognosis-oriented approach, i.e. treating modifiable risk factors for an unfavourable course of dizziness, may reduce dizziness-related impairment in older people in primary care.DesignCluster randomized controlled trial.Setting45 primary care practices in The Netherlands.Participants168 participants aged ?65y who consulted their general practitioner for dizziness and experienced significant dizziness-related impairment (Dizziness Handicap Inventory (DHI) ?30). Participants were part of to the intervention group (n = 83) or control group (n = 85), depending on whether they were enlisted in an intervention practice or in a control practice.InterventionsThe multifactorial intervention consisted of: medication adjustment in case of ?3 prescribed fall-risk-increasing drugs (FRIDs) and/or stepped mental health care in case of anxiety disorder and/or depression and/or exercise therapy in case of impaired functional mobility. The intervention was compared to usual care.Outcome measuresThe primary outcome was dizziness-related impairment. Secondary outcomes were quality of life (QoL), dizziness frequency, fall frequency, anxiety and depression, use of FRIDs.ResultsIntention-to-treat analysis showed no significant intervention effect on dizziness-related impairment (DHI score difference -0.69 [95% CI -5.66;4.28]; p = 0.79). The intervention proved effective in reducing the number of FRIDs (FRID difference -0.48 [95% CI -0.89;-0.06]; p = 0.02). No significant intervention effects were found on other secondary outcomes. The uptake of and adherence to the interventions was significantly lower in patients eligible for ?2 interventions compared to patients eligible for one intervention (p<0.001).ConclusionsThe multifactorial intervention for dizziness in older patients showed no significant intervention effect on most outcomes and adherence to the multifactorial intervention was low. Although multifactorial treatment for older dizzy people seems promising in theory, we question its feasibility in daily practice. Future research could focus on a sequential treatment for dizziness, e.g. measuring effectiveness of various evidence-based therapies in a stepwise approach.

Project description:BackgroundEffective multicomponent interventions in the community targeted at preventing frailty in at-risk older adults can promote healthy ageing. However, there is a lack of studies exploring the effectiveness of technology-enabled autonomous multi-domain community-based interventions for frailty. We developed a novel end-to-end System for Assessment and Intervention of Frailty (SAIF) with exercise, nutrition, and polypharmacy components. This pilot study aimed to explore SAIF's effectiveness in improving frailty status, physical performance and strength, and its usability in pre-frail older adults.Materials and methodsThis is a single arm 8-week pilot study in 20 community-dwelling older adults who were pre-frail, defined using the Clinical Frailty Scale (CFS) as CFS 3 + (CFS 3 and FRAIL positive) or CFS 4. For outcomes, we assessed frailty status using the modified Fried Frailty Phenotype (FFP) and CFS; physical performance using Short Physical Performance Battery (SPPB); and Hand Grip Strength (HGS) at baseline and 8-week. User experience was explored using the System Usability Scale (SUS), interest-enjoyment subscale of the Intrinsic Motivation Inventory and open-ended questions. We analyzed effectiveness using repeated-measures tests on pre-post scores, and usability using a convergent mixed-method approach via thematic analysis of open-ended responses and descriptive statistics of usability/interest-enjoyment scales.ResultsSixteen participants (71.8 ± 5.5 years) completed the 8-week study. There was a significant improvement in FFP score (-0.5, p < 0.05, effect size, r = 0.43), but not CFS (-1.0, p = 0.10, r = 0.29). Five (31.3%) improved in frailty status for both FFP and CFS. SPPB (+1.0, p < 0.05, r = 0.42) and HGS (+3.5, p < 0.05, r = 0.45) showed significant improvements. Three themes were identified: "Difficulty in module navigation" (barriers for SAIF interaction); "User engagement by gamification" (facilitators that encourage participation); and "Perceived benefits to physical health" (subjective improvements in physical well-being), which corroborated with SUS (68/100) and interest-enjoyment (3.9/5.0) scores. Taken together, user experience results cohere with the Senior Technology Acceptance and Adoption Model.ConclusionOur pilot study provides preliminary evidence of the effectiveness of SAIF in improving frailty status, physical performance and strength of pre-frail older adults, and offers user experience insights to plan the follow-up large-scale randomized controlled trial.

Project description:Higher levels of frailty result in higher risks of adverse frailty outcomes such as hospitalisation and mortality. There are, however, indications that more factors than solely frailty play a role in the development of these outcomes. The presence of resources, e.g. sufficient income and good self-management abilities, might slow down the pathway from level of frailty to adverse outcomes (e.g. mortality). In the present paper we studied whether resources (i.e. educational level, income, availability of informal care, living situation, sense of mastery and self-management abilities) moderate the impact of the level of frailty on the adverse outcomes mortality, hospitalisation and the development of disability over a two-year period.Longitudinal data on a sample of 2420 community-dwelling pre-frail and frail older people were collected. Participants filled out a questionnaire every six months, including measures of frailty, resources and outcomes. To study the moderating effects of the selected resources their interaction effects with levels of frailty on outcomes were studied by means of multiple logistics and linear regression models.Frail older participants had increased odds of mortality and hospitalisation, and had more deteriorating disability scores compared to their pre-frail counterparts. No moderating effects of the studied resources were found for the outcomes mortality and hospitalisation. Only for the outcome disability statistically significant moderating effects were present for the resources income and living situation, yet these effects were in the opposite direction to what we expected. Overall, the studied resources showed hardly any statistically significant moderating effects and the directions of the trends were inconsistent.Frail participants were more at risk of mortality, hospitalisation, and an increase in disability. However, we were unable to demonstrate a clear moderating effect of the studied resources on the adverse outcomes associated with frailty (among pre-frail and frail participants). More research is needed to increase insight into the role of moderating factors. Other resources or outcome measures should be considered.

Project description:ObjectivesDeprescribing has been proposed as a way to reduce polypharmacy in frail older people. We aimed to reduce the number of medicines consumed by people living in residential aged care facilities (RACF). Secondary objectives were to explore the effect of deprescribing on survival, falls, fractures, hospital admissions, cognitive, physical, and bowel function, quality of life, and sleep.MethodsNinety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were randomised in an open study. The intervention group (n = 47) received a deprescribing intervention, the planned cessation of non-beneficial medicines. The control group (n = 48) received usual care. Participants were monitored for twelve months from randomisation. Primary outcome was change in the mean number of unique regular medicines. All outcomes were assessed at baseline, six, and twelve months.ResultsStudy participants had a mean age of 84.3 ± 6.9 years and 52% were female. Intervention group participants consumed 9.6 ± 5.0 and control group participants consumed 9.5 ± 3.6 unique regular medicines at baseline. Of the 348 medicines targeted for deprescribing (7.4 ± 3.8 per person, 78% of regular medicines), 207 medicines (4.4 ± 3.4 per person, 59% of targeted medicines) were successfully discontinued. The mean change in number of regular medicines at 12 months was -1.9 ± 4.1 in intervention group participants and +0.1 ± 3.5 in control group participants (estimated difference 2.0 ± 0.9, 95%CI 0.08, 3.8, p = 0.04). Twelve intervention participants and 19 control participants died within 12 months of randomisation (26% versus 40% mortality, p = 0.16, HR 0.60, 95%CI 0.30 to 1.22) There were no significant differences between groups in other secondary outcomes. The main limitations of this study were the open design and small participant numbers.ConclusionsDeprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no significant adverse effects on survival or other clinical outcomes.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000370909.

Project description:BackgroundPoor outcomes and high resource-use are observed for frail older people discharged from acute medical units. A specialist geriatric medical intervention, to facilitate Comprehensive Geriatric Assessment, was developed to reduce the incidence of adverse outcomes and associated high resource-use in this group in the post-discharge period.ObjectiveTo examine the costs and cost-effectiveness of a specialist geriatric medical intervention for frail older people in the 90 days following discharge from an acute medical unit, compared with standard care.MethodsEconomic evaluation was conducted alongside a two-centre randomised controlled trial (AMIGOS). 433 patients (aged 70 or over) at risk of future health problems, discharged from acute medical units within 72 hours of attending hospital, were recruited in two general hospitals in Nottingham and Leicester, UK. Participants were randomised to the intervention, comprising geriatrician assessment in acute units and further specialist management, or to control where patients received no additional intervention over and above standard care. Primary outcome was incremental cost per quality adjusted life year (QALY) gained.ResultsWe undertook cost-effectiveness analysis for 417 patients (intervention: 205). The difference in mean adjusted QALYs gained between groups at 3 months was -0.001 (95% confidence interval [CI]: -0.009, 0.007). Total adjusted secondary and social care costs, including direct costs of the intervention, at 3 months were £4412 (€5624, $6878) and £4110 (€5239, $6408) for the intervention and standard care groups, the incremental cost was £302 (95% CI: 193, 410) [€385, $471]. The intervention was dominated by standard care with probability of 62%, and with 0% probability of cost-effectiveness (at £20,000/QALY threshold).ConclusionsThe specialist geriatric medical intervention for frail older people discharged from acute medical unit was not cost-effective. Further research on designing effective and cost-effective specialist service for frail older people discharged from acute medical units is needed.Trial registrationISRCTN registry ISRCTN21800480 http://www.isrctn.com/ISRCTN21800480.

Project description:Frailty is a highly prevalent condition in old age leading to vulnerability and greater risk of adverse health outcomes and disability. Detecting and tackling frailty at an early stage can prevent disability. The purpose of this study is to evaluate the effectiveness of a multifactorial intervention program to modify frailty parameters, muscle strength, and physical and cognitive performance in people aged 65 years or more. It also assesses changes from baseline in falls, hospitalizations, nutritional risk, disability, institutionalization, and home-care.The current study is a randomised single-blind, parallel-group clinical trial, with a one and a half year follow-up, conducted in eight Primary Health Care Centres located in the city of Barcelona. Inclusion criteria are to be aged 65 years or older with positive frailty screening, timed get-up-and-go test between 10 to 30 seconds, and Cognition Mini-Exam (MEC-35) of Lobo greater than or equal to 18. A total of 352 patients have been equally divided into two groups: intervention and control. Sample size calculated to detect a 0.5 unit difference in the Short Physical Performance Battery (Common SD: 1.42, 20% lost to follow-up). In the intervention group three different actions on frailty dimensions: rehabilitative therapy plus intake of hyperproteic nutritional shakes, memory workshop, and medication review are applied to sets of 16 patients. Participants in both intervention and control groups receive recommendations on nutrition, healthy lifestyles, and home risks.Evaluations are blinded and conducted at 0, 3, and 18 months. Intention to treat analyses will be performed. Multivariate analysis will be carried out to assess time changes of dependent variables.It is expected that this study will provide evidence of the effectiveness of a multidisciplinary intervention on delaying the progression from frailty to disability in the elderly. It will help improve the individual's quality of life and also reduce the rates of falls, hospital admissions, and institutionalizations, thus making the health care system more efficient. This preventive intervention can be adapted to diverse settings and be routinely included in Primary Care Centres as a Preventive Health Programme.ClinicalTrials.gov PRS: NCT01969526. Date of registration: 10/21/2013.

Dataset Information

Effectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: study protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: study protocol for a randomised controlled trial.

Similar Datasets

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