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A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol.

ABSTRACT: Background:Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to assess feasibility of outcome measurements and sample size when conducting a pilot cluster randomized trial to evaluate community-dwelling older adults being involved in activities in relation to meals in a rehabilitation program. Methods:This cluster randomized controlled study will consist of two clusters of a total of 5 community aged care areas; the intervention cluster, which hold 3 community aged care areas and the control cluster which hold 2 areas. The 130 community-dwelling older adults, receiving meals-on-wheels, will randomly be allocated to either the intervention cluster consisting of 8 weeks of participation in a rehabilitation program led by a Case Manager or the control cluster receiving usual community aged care. The primary outcome will be assessment of data collection (ratio between completed- and non-completed data) and assessment of sample size. The secondary clinical outcomes will be health-related quality of life (EQ-5D-3 L), muscle strength (chair stand), nutritional status (weight/BMI), loneliness (UCLA scale), mental well-being (Warwich-Edinburgh scale), self-efficacy (General Self-Efficacy scale), satisfaction with food-related life (SWFL scale) and refrigerator content. Discussion:This study evaluates community-dwelling older adults receiving support at home, using involvement in activities related to meals with a rehabilitation approach, and this is a new area of research and will therefore be contributing in developing and refining consistent practices of rehabilitation programs. Trial registration:ClinicalTrials.gov (registration no: NCT03289598). The protocol has been sent to the Danish Ethical Board which has concluded that approval is not needed and that the study can be carried on as described. Approval by The Danish Data Protection Agency has been giving through general approval for use of data in The City of Odense and will follow rules for obtaining the data accordingly.

SUBMITTER: Husted MM

PROVIDER: S-EPMC6091176 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol.

Husted M M MM Beck A M AM Ulrikkeholm L K LK

Pilot and feasibility studies 20180806

<h4>Background</h4>Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to assess feasibility of outcome measurements and sample size when conductin ...[more]

PMID: 30123525

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Project description:BackgroundProtein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 30%-42% at risk. There is no internationally agreed protocol for the nutritional treatment of malnutrition in the care home setting. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements, but a trial comparing the efficacy of interventions is necessary. In order to define outcomes and optimise the design for an adequately powered, low risk of bias cluster randomised controlled trial, a feasibility trial with 6-month intervention is being run, to assess protocol procedures, recruitment and retention rates, consent processes and resident and staff acceptability.MethodsTrial recruitment began in September 2013 and concluded in December 2013. Six privately run care homes in Solihull, England, were selected to establish feasibility within different care home types. Residents with or at risk of malnutrition with no existing dietetic intervention in place were considered for receipt of the allocated intervention. Randomisation took place at the care home level, using a computer-generated random number list to allocate each home to either a dietetic intervention arm (food-based or prescribed supplements) or the standard care arm, continued for 6 months. Dietetic intervention aimed to increase daily calorie intake by 600 kcal and protein by 20-25 g.ResultsThe primary outcomes will be trial feasibility and acceptability of trial design and allocated interventions. A range of outcome assessments and data collection tools will be evaluated for feasibility, including change in nutrient intake, anthropometric parameters and patient-centric measures, such as quality of life and self-perceived appetite.ConclusionsThe complexities inherent in care home research has resulted in the under representation of this population in research trials. The results of this feasibility trial will be used to inform the development and design of a future cluster randomised controlled trial to compare food-based intervention with prescribed oral nutritional supplements (ONS) in the treatment of malnutrition within the care home population.Trial registrationCurrent Controlled Trials ISRCTN38047922.

Project description:BackgroundThe portability and multiple functionalities of mobile devices make them well suited for collecting field data for naturalistic research, which is often beset with complexities in recruitment and logistics. This paper describes the implementation of a research protocol using mobile devices to study nurses' exchanges of patient information at change of shift.MethodsNurses from three medical and surgical units of an acute care teaching hospital in Montreal, Canada, were invited to participate. On 10 selected days, participants were asked to record their handoffs using mobile devices and to complete paper questionnaires regarding these exchanges. Nurse acceptance of mobile devices was assessed using a 30-item technology acceptance questionnaire and focus group interviews. The principal feasibility indicator was whether or not 80 complete handoffs could be collected on each unit.ResultsFrom October to December 2017, 63 of 108 eligible nurses completed the study. Results suggest that the use of mobile devices was acceptable to nurses, who felt that the devices were easy to use but did not improve their job performance. The principal feasibility criterion was met, with complete data collected for 176, 84, and 170 of the eligible handoffs on each unit (81% of eligible handoffs). The research protocol was acceptable to nurses, who felt the study's demands did not interfere with their clinical work.ConclusionsThe research protocol involving mobile devices was feasible and acceptable to nurses. Nurses felt the research protocol, including the use of mobile devices, required minimal investment of time and effort. This suggests that their decision to participate in research involving mobile devices was based on their perception that the study protocol and the use of the device would not be demanding. Further work is needed to determine if studies involving more sophisticated and possibly more demanding technology would be equally feasible and acceptable to nurses.

Project description:BackgroundMotor (re)learning via technology-dependent therapy has the potential to complement traditional therapies available to older adults living with stroke after hospital discharge and increase therapy dose. To date, little is known about the feasibility of technology-dependent therapy in a home setting for this population.ObjectiveTo develop a technology-dependent therapy that provides mental and physical training for older adults with stroke and assess feasibility. Specifically we ask, "Can it work"?DesignSingle group repeated measures.Methods13 participants, aged 18 years and over, were recruited over a six-month period. All participants had mild upper limb impairment following a stoke and were no longer receiving intensive rehabilitation. All participants received 18 days of technology-dependent therapy in their own home. Information was gathered on recruitment and retention, usability, and suitability of outcome measures.Results11 participants completed the study. The recruitment rate (number recruited/number canvassed; 10.7%) suggests 1907 participants would need to be canvassed to recruit the necessary sample size (n = 204) for a definitive trial designed to provide 90% power at 5% level of significance to detect a clinically meaningful difference of 5.7 points on the Action Research Arm Test. The usability of the application was rated as exceptional on the System Usability Scale. Effectiveness cannot be determined from this study; however, there was a trend for improvement in measures of upper limb function and emotional well-being. Limitations. The study was limited by a relatively small sample size and lack of control group.ConclusionsThis study demonstrated proof of concept of a technology-dependent therapy for upper limb rehabilitation following stroke. The data suggest a definitive trial is feasible, additional strategies to improve recruitment should be considered. Outcome measures aligned with the residual motor function of participants are required.

Project description:Purpose:The overall purpose of this study was to explore participants' and physiotherapists' experiences regarding the acceptability, implementation, and practicality of a novel group-based multifactorial falls prevention activity programme for community-dwelling older people after stroke. Specifically, the purpose was to explore if and how participating could impact on the participants' health-related quality of life (HRQoL) in terms of their daily lived experience regarding physical, mental, emotional and social well-being. A secondary purpose was to explore whether participating in the programme could positively influence participants' balance, strength, falls efficacy, mobility and motor impairment of the trunk. Materials and Methods:This was an exploratory mixed-method Phase I feasibility study. A convenience sample of five older community-dwelling people after stroke participated in a novel eight-week multifactorial activity programme which included falls education, a mix of individually tailored and group-based strength and balance exercises, exploring limits of stability and safe landing techniques and a social element. Qualitative data from post-intervention interview transcripts with the participants and the physiotherapists who delivered the programme were thematically analysed using both deductive and inductive approaches to explore the participants' and therapists' experiences with the programme. Quantitative outcomes included balance, strength, falls efficacy, mobility and motor impairment of the trunk. Results:The programme was deemed feasible in terms of acceptability, implementation and practicality by the participants as well as the physiotherapists delivering the programme. The overarching theme regarding HRQoL identified that participating in the programme was perceived to empower the participants living with stroke and positively influenced their daily physical, mental, emotional and social well-being. Participant outcomes showed a change in the direction of improvements in balance, strength, mobility, motor impairment of the trunk and reduced concerns about falling. Subjectively, participants only reported perceived improvements in balance and strength. Conclusion:Running a novel multifactorial falls prevention activity programme for older community-dwelling people after stroke was feasible. Participating in the programme helped participants to perceive improved balance, strength and empower them to make meaningful changes, improving their daily lived experiences. A future fully powered study could build on these results to investigate physical improvements, prevention of falls and improvements to domains of HRQoOL.

Project description:BackgroundHeart failure (HF), is a leading cause of cardiovascular morbidity and mortality in Sub-Saharan Africa. Cardiac rehabilitation (CR) is known to improve functional capacity and reduce morbidity associated with HF. Although CR is a low-cost intervention, global access and adherence rates to CR remain poor. In regions such as Western Kenya, CR programs do not exist. We sought to establish the feasibility CR for HF in this region by testing adherence to institution and home-based models of CR.MethodsOne hundred participants with New York Heart Association (NYHA) class II and III HF symptoms were prospectively enrolled from a tertiary health facility in Western Kenya. Participants were non-randomly assigned to participate in one of two CR models based on their preference. Institution based cardiac rehabilitation (IBCR) comprised 36 facility-based exercise sessions over a period of 12 weeks. Home based cardiac rehabilitation (HBCR) comprised weekly pedometer guided exercise targets over a period of 12 weeks. An observational arm (OA) receiving usual care was also enrolled. The primary endpoint of CR feasibility was assessed based on study participants to adherence to at least 25% of exercise sessions. Secondary outcomes of change in NYHA symptom class, and six-minute walk time distance (6MWTD) were also evaluated. Data were summarized and analyzed as means (SD) and frequencies. Paired t-tests, Chi Square, Fisher's, and ANOVA tests were used for comparisons.FindingsMean protocol adherence was greater than 25% in both CR models; 46% ± 18 and 29% ± 11 (P < 0.05) among IBCR and HBCR participants respectively. Improvements by at least one NYHA class were observed among 71%, 41%, and 54%, of IBCR, HBCR and OA participants respectively. 6MWTD increased significantly by a mean of 31 ± 65 m, 40 ± 55 m and 38 ± 71 m in the IBCR, HBCR and OA respectively (P < 0.05).ConclusionsIBCR and HBCR, are feasible rehabilitation models for HF in Western Kenya. Whereas improvement in functional capacity was observed, effectiveness of CR in this population remains unknown. Future randomized studies evaluating effect size, long term efficacy, and safety of cardiac rehabilitation in low resource settings such as Kenya are recommended.

Project description:Purpose: People with severe mental illness are sedentary, have high cardio-metabolic risks and significantly reduced life expectancy. Despite considerable data regarding positive physical and mental health outcomes following exercise interventions, implementation and evaluation of real-world programs is lacking. The primary aim of this study was to assess the feasibility of an exercise intervention implemented by exercise physiology (EP) students within a residential rehabilitation unit for residents with severe mental illness, together with assessment of a range of secondary physical and mental health outcomes pre- and post- the intervention. Design: Single arm, prospective pilot study evaluating outcomes pre- and post- a 10 week intervention. Method: Inactive people with severe mental illness participated in a mixed aerobic and resistance exercise intervention, three times per week for 10 weeks. Data was obtained from a sample of 16 residents with severe mental illness; primary diagnosis schizophrenia (n = 12). Primary outcomes were feasibility as assessed using recruitment, retention and participation rates, as well as reasons for withdrawal and amount of exercise achieved. Secondary outcomes included: functional exercise capacity was measured by the 6-min walk test; metabolic data obtained from anthropometric measurements; blood pressure; fasting cholesterol and blood sugar levels; and physical activity levels and mental health as assessed by self- administered questionnaires measured before and after the intervention. Results: Broad level acceptance of the program: high recruitment (81%), retention (77%), and participation (78%) rates were observed. Promising improvements in functional exercise capacity, volume of exercise, and negative symptoms was demonstrated in those who completed. Conclusions: Exercise interventions delivered by EP students in a residential rehabilitation setting for people with SMI are feasible; group setting, supervision and choice for engagement are important considerations. Evaluation of longitudinal, multi site studies, with the addition of dietary interventions within residential rehabilitation units are warranted. Addressing cost feasibility and cost effectiveness of such programs is recommended. The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) number, Unique Identifier: ACTRN 12618000478213, http://www.anzctr.org.au Universal trial number (UTN) - U1111-1211-4009.

Dataset Information

A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol.

Publications

A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol.

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