scholarly journals Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial

PLoS Medicine ◽  
2018 ◽  
Vol 15 (2) ◽  
pp. e1002500 ◽  
Author(s):  
Clive Ballard ◽  
Anne Corbett ◽  
Martin Orrell ◽  
Gareth Williams ◽  
Esme Moniz-Cook ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Nursing Homes ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
People With Dementia ◽  
Care Training ◽  
Randomised Controlled

scholarly journals TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial

2019 ◽  
Author(s):  
Jessica Frost ◽  
J Athene Lane ◽  
Nikki Cotterill ◽  
Mandy Fader ◽  
Lucy Hackshaw-McGeagh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their General Practitioner (GP) in the first instance, with conservative therapies recommended as initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. Methods TRIUMPH is a 2-arm cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) General Practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and health care professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post-consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. Discussion It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care therefore holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic cluster RCT will provide robust evidence in a primary care setting to inform future guidelines.

scholarly journals Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017740 ◽  
Author(s):  
Christiane Muth ◽  
Lorenz Uhlmann ◽  
Walter E Haefeli ◽  
Justine Rochon ◽  
Marjan van den Akker ◽  
...  
Keyword(s):  
Quality Of Life ◽  
General Practice ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesInvestigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.DesignPragmatic, cluster randomised controlled trial with general practice as unit of randomisation.Setting72 general practices in Hesse, Germany.Participants505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.InterventionsIntervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.Outcome measuresThe primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months’ follow-up: quality of life, functioning, medication adherence, and so on.ResultsAt baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0–5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI −0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).ConclusionsThe intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.Trial registration numberISRCTN99526053. NCT01171339; Results.

scholarly journals Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M. Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract Background As the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study. Methods The PRESIDE study is designed as a two-arm, parallel-group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n = 80) and their carer (n = 80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away or to wait for 3 months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 min, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and 3 and 6 months post-baseline. Discussion Despite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers. Trial registration Unique identification number in ISRCTN registry: ISRCTN10201482. Date registered: 12 May 2020

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