scholarly journals Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial

2011 ◽  
Vol 66 (9) ◽  
pp. 782-790 ◽  
Author(s):  
Florence Clark ◽  
Jeanne Jackson ◽  
Mike Carlson ◽  
Chih-Ping Chou ◽  
Barbara J Cherry ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Older People ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Well Elderly ◽  
Randomised Controlled

scholarly journals Protocol of a 12-month multifactorial eHealth programme targeting balance, dual-tasking and mood to prevent falls in older people: the StandingTall+ randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e051085
Author(s):  
Kimberley S van Schooten ◽  
Michele L Callisaya ◽  
Bridianne O'Dea ◽  
Thomas Lung ◽  
Kaarin Anstey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Older People ◽  
Fall Risk ◽  
Fear Of Falling ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
Well Being ◽  
Cost Utility ◽  
Control Group ◽  
Randomised Controlled

IntroductionFalls have a multifactorial aetiology, which may limit the effectiveness of the common approach of exercise as the sole intervention strategy. Multifactorial interventions could be more effective in people at high risk of falling; however, the focus of such interventions has traditionally been quite narrow. This paper describes the design of a randomised controlled trial that will evaluate the effectiveness of an eHealth programme, which addresses cumulative effects of key fall-risk factors across the triad of physical, affective and cognitive functions on falls in older people.Methods and analysis518 older people aged 65 years and over with high fall risk, defined as having a history of falls in the past 6 months, self-reported fear of falling or being aged 80 years or over, will be recruited via local advertisements, newsletters and presentations, and randomised to an intervention or health education control group. The intervention comprises balance exercise, cognitive-motor exercise and cognitive–behavioural therapy, with their dosage based on participant’s baseline balance, executive function and mood. The primary outcome is the rate of falls in the 12 months after randomisation. Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme. Data will be analysed following intention to treat to gauge real-world effectiveness. We will further determine complier averaged causal effects to correct for varying adherence and conduct economic analyses to gain insight into cost-effectiveness and cost–utility.Ethics and disseminationEthical approval was obtained from the University of New South Wales (UNSW) Human Research Ethics Committee in December 2017. Outcomes will be disseminated via peer-reviewed articles, conference presentations, community events and media releases.Trial registration numberACTRN12619000540112.

scholarly journals Putting Life in Years (PLINY): a randomised controlled trial and mixed-methods process evaluation of a telephone friendship intervention to improve mental well-being in independently living older people

2014 ◽  
Vol 2 (7) ◽  
pp. 1-222 ◽  
Author(s):  
Daniel Hind ◽  
Gail Mountain ◽  
Rebecca Gossage-Worrall ◽  
Stephen J Walters ◽  
Rosie Duncan ◽  
...  
Keyword(s):  
Public Health ◽  
Mental Health ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Controlled Trial ◽  
Well Being ◽  
Public Health Research ◽  
Intervention Fidelity ◽  
Sf 36 ◽  
Randomised Controlled

BackgroundSocial isolation in older adults is associated with morbidity. Evaluating interventions to promote social engagement is a research priority.MethodsA parallel-group randomised controlled trial was planned to evaluate whether telephone friendship (TF) improves the well-being of independently living older people. An internal pilot aimed to recruit 68 participants by 30 September 2012, with 80% retained at 6 months. Randomisation was web based and only analysts were blind to allocation. A service provider was contracted to train 10 volunteer facilitators by 1 April 2012 and 10 more by 1 September 2012. Participants were aged > 74 years with good cognitive function and living independently in an urban community. The intervention arm of the trial consisted of manualised TF with standardised training: (1) one-to-one befriending (10- to 20-minute calls once per week for up to 6 weeks made by volunteer facilitators) followed by (2) TF groups of six participants (1-hour teleconferences once per week for 12 weeks facilitated by the same volunteer). Friendship groups aimed to enhance social support and increase opportunities for social interaction to maintain well-being. This was compared with usual health and social care provision. The primary clinical outcome was the Short Form questionnaire-36 items (SF-36) mental health dimension score at 6 months post randomisation. Qualitative research assessing intervention acceptability (participants) and implementation issues (facilitators) and an intervention fidelity assessment were also carried out. Intervention implementation was documented through e-mails, meeting minutes and field notes. Acceptability was assessed through framework analysis of semistructured interviews. Two researchers coded audio recordings of telephone discussions for fidelity using a specially designed checklist.ResultsIn total, 157 people were randomised to the TF group (n = 78) or the control group (n = 79). Pilot recruitment and retention targets were met. Ten volunteers were trained by 1 September 2012; after volunteer attrition, three out of the 10 volunteers delivered the group intervention. In total, 50 out of the 78 TF participants did not receive the intervention and the trial was closed early. A total of 56 people contributed primary outcome data from the TF (n = 26) and control (n = 30) arms. The mean difference in SF-36 mental health score was 9.5 (95% confidence interval 4.5 to 14.5) after adjusting for age, sex and baseline score. Participants who were interviewed (n = 19) generally declared that the intervention was acceptable. Participant dissatisfaction with closure of the groups was reported (n = 4). Dissatisfaction focused on lack of face-to-face contact and shared interests or attitudes. Larger groups experienced better cohesion. Interviewed volunteers (n = 3) expressed a lack of clarity about procedures, anxieties about managing group dynamics and a lack of confidence in the training and in their management and found scheduling calls challenging. Training was 91–95% adherent with the checklist (39 items; three groups). Intervention fidelity ranged from 30.2% to 52.1% (28–41 items; three groups, three time points), indicating that groups were not facilitated in line with training, namely with regard to the setting of ground rules, the maintenance of confidentiality and facilitating contact between participants.ConclusionsAlthough the trial was unsuccessful for a range of logistical reasons, the experience gained is of value for the design and conduct of future trials. Participant recruitment and retention were feasible. Small voluntary sector organisations may be unable to recruit, train and retain adequate numbers of volunteers to implement new services at scale over a short time scale. Such risks might be mitigated by multicentre trials using multiple providers and specialists to recruit and manage volunteers.Trial registrationCurrent Controlled Trials ISRCTN28645428.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 2, No. 7. See the NIHR Journals Library website for further project information.

scholarly journals Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Human Health ◽  
Controlled Trial ◽  
Informal Settlements ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Abundance And Diversity ◽  
Randomised Controlled ◽  
Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

A randomised controlled trial to test a non-metallic deodorant used during a course of radiotherapy

2000 ◽  
Vol 1 (4) ◽  
pp. 205-212 ◽  
Author(s):  
A. Gee ◽  
D. Moffitt ◽  
M. Churn ◽  
R.D. Errington
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Benefits ◽  
Weekly Basis ◽  
Skin Reactions ◽  
Treated Area ◽  
The Past ◽  
Randomised Controlled ◽  
Larger Sample

Background: Radiotherapy skin reactions have been well documented in the past. Until recently, washing of the treated area and the use of perfumed products that contain metals has not been advocated during treatment. The aims of this study were to assess the skin reactions of patients using a non-metallic deodorant and to see whether there were any psychological benefits from being able to use the deodorant.Method: 41 women attending for radiotherapy to either the breast or breast and axilla were recruited into the trial. They were randomised into one of two groups. Complete data was obtained for 36 patients. 20 patients used the deodorant and 16 did not. Any skin reactions noted were recorded on a weekly basis. Patients were also asked to complete a questionnaire relating to feelings and activities and to comment on the deodorant if they had used it.Results: Skin reactions did seem to be slightly worse in the patients using deodorant, and it was only in this group of patients that axillary reactions were noted. However, neither of these results were statistically significant. The use of the deodorant did not have any impact on the psychological well being of the patients, but patients using it had found it pleasant to use and the majority said that they would use it again.Conclusion: Further study is indicated to look at skin reactions using the deodorant with a larger sample of patients.

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