scholarly journals Using motivational interviewing combined with digital shoe-fitting to improve adherence to wearing orthopedic shoes in people with diabetes at risk of foot ulceration: study protocol for a cluster-randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M. Jongebloed-Westra ◽  
C. Bode ◽  
J. J. van Netten ◽  
P. M. ten Klooster ◽  
S. H. Exterkate ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Motivational Interviewing ◽  
Usual Care ◽  
Activity Monitor ◽  
The Novel ◽  
Custom Made ◽  
Care Approach ◽  
Orthopedic Shoes

Abstract Background Diabetic foot ulcers have a high impact on mobility and daily functioning and lead to high treatment costs, for example, by hospitalization and amputation. To prevent (re)ulcerations, custom-made orthopedic shoes are considered essential. However, adherence to wearing the orthopedic shoes is low, and improving adherence was not successful in the past. We propose a novel care approach that combines motivational interviewing (MI) with a digital shoe-fitting procedure to improve adherence to orthopedic shoes. The aim of this trial is to assess the (cost-)effectiveness of this novel care approach compared to usual care (no MI and casting-based shoe-fitting) in promoting footwear adherence and ulcer prevention. Methods The trial will include people with diabetes, with IWGDF Risk categories 1–3, who have been prescribed orthopedic shoes. Participants will be randomized at the level of the podiatrist to the novel care approach or usual care. The primary outcome is the proportion of participants who adhere to the use of their orthopedic shoes, that is, who take at least 80% of their total daily steps with orthopedic shoes. A temperature microsensor will be built into the participants’ orthopedic shoes to measure wearing time continuously over 12 months. In addition, daily activity will be measured periodically using log data with an activity monitor. Data from the temperature microsensor and activity monitor will be combined to calculate adherence. (Re-)experienced complications after receiving orthopedic shoes will be registered. Questionnaires and interviews will measure the experiences of participants regarding orthopedic shoes, experiences of podiatrists regarding motivational interviewing, care consumption, and quality of life. Differences in costs and quality of life will be determined in a cost-effectiveness analysis. Discussion This trial will generate novel insights into the socio-economic and well-being impact and the clinical effectiveness of the novel care approach on adherence to wearing orthopedic shoes. Trial registration Netherlands Trial Register NL7710. Registered on 6 May 2019

scholarly journals Economic evaluation alongside a randomised controlled trial to assess the effectiveness and cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy

2020 ◽  
pp. 096452842092028
Author(s):  
Alex Molassiotis ◽  
Bryony Dawkins ◽  
Roberta Longo ◽  
Lorna KP Suen ◽  
Hui Lin Cheng ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Care ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Peripheral Neuropathy ◽  
Usual Care ◽  
Base Case ◽  
Cost Effective Treatment ◽  
The Cost

Objective To assess the cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy (CIPN) in Hong Kong. Methods A within trial cost-utility analysis with the primary endpoint for the economic evaluation being the Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER) over 14 weeks of treatment. A secondary cost-effectiveness analysis was undertaken with the endpoint being change in pain as measured on the Brief Pain Inventory (BPI). Results Eighty-seven patients were randomised to acupuncture or usual care. Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of −1.8 and −1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of −1.5 and −0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms. However, in the economic evaluation there was little difference in QALYs between the two arms (mean change 0.209 and 0.200 in the acupuncture and usual care arms, respectively). Also, costs yielded deterministic ICERs of HK$616,965.62, HK$824,083.44 and HK$540,727.56 per QALY gained from the health care provider perspective, the societal perspective and the patient perspective, respectively. These costs are significantly higher than the cost-effectiveness threshold of HK$180,450 that was used for the base case analysis. Conclusion While acupuncture can improve symptoms and quality of life indicators related to CIPN, it is unlikely to be a cost-effective treatment for CIPN-related pain in health care systems with limited resources. Trial registration number NCT02553863 (ClinicalTrials.gov) post-results.

scholarly journals Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation (‘My Therapy’): protocol for a stepped-wedge cluster randomised trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natasha K. Brusco ◽  
Christina L. Ekegren ◽  
Nicholas F. Taylor ◽  
Keith D. Hill ◽  
Annemarie L. Lee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Health Service ◽  
Usual Care ◽  
Inpatient Rehabilitation ◽  
Functional Independence ◽  
Trial Registration ◽  
Self Management ◽  
Implementation Trial

Abstract Background Ensuring patients receive an effective dose of therapeutic exercises and activities is a significant challenge for inpatient rehabilitation. My Therapy is a self-management program which encourages independent practice of occupational therapy and physiotherapy exercises and activities, outside of supervised therapy sessions. Methods This implementation trial aims to determine both the clinical effectiveness of My Therapy on the outcomes of function and health-related quality of life, and cost-effectiveness per minimal clinically important difference (MCID) in functional independence achieved and per quality adjusted life year (QALY) gained, compared to usual care. Using a stepped-wedge cluster randomised design, My Therapy will be implemented across eight rehabilitation wards (inpatient and home-based) within two public and two private Australian health networks, over 54-weeks. We will include 2,160 patients aged 18 + years receiving rehabilitation for any diagnosis. Each ward will transition from the usual care condition (control group receiving usual care) to the experimental condition (intervention group receiving My Therapy in addition to usual care) sequentially at six-week intervals. The primary clinical outcome is achievement of a MCID in the Functional Independence Measure (FIM™) at discharge. Secondary outcomes include improvement in quality of life (EQ-5D-5L) at discharge, length of stay, 30-day re-admissions, discharge accommodation, follow-up rehabilitation services and adverse events (falls). The economic outcomes are the cost-effectiveness per MCID in functional independence (FIM™) achieved and per QALY gained, for My Therapy compared to usual care, from a health-care sector perspective. Cost of implementation will also be reported. Clinical outcomes will be analysed via mixed-effects linear or logistic regression models, and economic outcomes will be analysed via incremental cost-effectiveness ratios. Discussion The My Therapy implementation trial will determine the effect of adding self-management within inpatient rehabilitation care. The results may influence health service models of rehabilitation including recommendations for systemic change to the inpatient rehabilitation model of care to include self-management. Findings have the potential to improve patient function and quality of life, and the ability to participate in self-management. Potential health service benefits include reduced hospital length of stay, improved access to rehabilitation and reduced health service costs. Trial registration This study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12621000313831; registered 22/03/2021, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380828&isReview=true).

scholarly journals The Cost-Effectiveness of Non-Drug Interventions That Reduce Nursing Home Admissions for People With Dementia

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 229-229
Author(s):  
Eric Jutkowitz ◽  
Fernando Alarid-Escudero ◽  
Peter Shewmaker ◽  
Joseph Gaugler ◽  
Laura Pizzi
Keyword(s):  
Quality Of Life ◽  
Nursing Home ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Disease Stage ◽  
Family Nursing ◽  
Moderate Dementia ◽  
The Cost ◽  
Drug Interventions

Abstract Although people generally want to age in their community, individuals living with dementia are likely to move to a nursing home. In randomized trials, psychosocial interventions reduce the risk of people living with dementia transitioning to a nursing home, but the cost-effectiveness of these interventions is unknown. We used an evidence-based mathematical model to simulate a place of residence (community or nursing home) for people living with dementia. Our model also predicts time caregiving, health care costs, and quality of life. We modeled the reduction in nursing home rate (i.e., hazard ratio (HR) treatment effect) identified from two trials of non-drug interventions for people living with dementia and their caregiver. Using trial data, we account for the disease stage of when interventions are implemented. Specifically, we modeled MIND (HR: 0.63; 18-month effect), an in-home intervention for people with mild-moderate dementia, and the NYU Caregiver Intervention (HR: 0.53; 42-month effect), which is for people with moderate dementia. We evaluated each intervention’s cost-effectiveness relative to usual care for the duration of the intervention from a societal perspective. The MIND and NYU Caregiver Intervention resulted in $23,900, and $6,600 costs savings relative to usual care, respectively. The model predicted an improvement in the quality of life for people living with dementia for both interventions. The largest cost saving was attributed to reductions in family nursing home spending. Medicare and Medicaid received modest cost savings but are likely to be tasked with paying for these interventions.

scholarly journals A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis: a cost-effectiveness analysis

Rheumatology ◽  
2020 ◽  
Vol 60 (1) ◽  
pp. 277-287 ◽  
Author(s):  
Hayley McBain ◽  
Chris Flood ◽  
Michael Shipley ◽  
Abigail Olaleye ◽  
Samantha Moore ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Short Form ◽  
Cost Effective ◽  
Self Monitoring ◽  
The Cost ◽  
Monitoring Service ◽  
The Impact

Abstract Objective To determine whether a patient-initiated DMARD self-monitoring service for people on MTX is a cost-effective model of care for patients with RA or PsA. Methods An economic evaluation was undertaken alongside a randomized controlled trial involving 100 patients. Outcome measures were quality of life and ESR assessed at baseline and post-intervention. Costs were calculated for healthcare usage using a United Kingdom National Health Service economic perspective. Sensitivity analysis was performed to explore the impact of nurse-led telephone helplines. Uncertainty around the cost-effectiveness ratios was estimated by bootstrapping and analysing the cost-effectiveness planes. Results Fifty-two patients received the intervention and 48 usual care. The difference in mean cost per case indicated that the intervention was £263 more expensive (P < 0.001; 95% CI: £149.14, £375.86) when the helpline costs were accounted for and £94 cheaper (P = 0.08; 95% CI: –£199.26, £10.41) when these costs were absorbed by the usual service. There were, however, statistically significant savings for the patient (P = 0.02; 95% CI: −£28.98, £3.00). When costs and effectiveness measures of ESR and quality of life measured, using the Short Form-12v1, were combined this did not show the patient-initiated service to be cost-effective at a statistically significant level. Conclusion This patient-initiated service led to reductions in primary and secondary healthcare services that translated into reduced costs, in comparison with usual care, but were not cost-effective. Further work is needed to establish how nurse-led telephone triage services are integrated into rheumatology services and the associated costs of setting up and delivering them. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, ISRCTN21613721

scholarly journals Feasibility study of a multicentre cluster randomised control trial to investigate the clinical and cost-effectiveness of a structured diagnostic pathway in primary care for chronic breathlessness: protocol paper

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e057362
Author(s):  
Gillian Doe ◽  
Jill Clanchy ◽  
Simon Wathall ◽  
Stacey Chantrell ◽  
Sarah Edwards ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Health Related Quality ◽  
Diagnostic Pathway ◽  
Cluster Randomised ◽  
Related Quality ◽  
Health Related

IntroductionChronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care.Methods and analysisTen general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is ‘usual care’ and the study experience.Ethics and disseminationThe Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available.Trial registration numberISRCTN14483247.

ДИАГНОСТИКА ХРОНИЧЕСКИХ ИНДУЦИРОВАННЫХ КРАПИВНИЦ

2019 ◽  
pp. 5-13
Author(s):  
E.Yu. Borzova
Keyword(s):  
Quality Of Life ◽  
Biological Therapy ◽  
Treatment Algorithm ◽  
The Novel ◽  
International Guidelines ◽  
Systemic Reactions ◽  
Significant Impairment ◽  
Challenge Tests

Хронические индуцированные крапивницы имеют важное социальноэкономическое значение вследствие риска развития системных реакций и значительного снижения качества жизни пациентов. Диагностика хронических индуцированных крапивниц основывается на анамнестических данных и проведении провокационных тестов. Современный протокол ведения больных хронической крапивницей включает применение неседативных антигистаминных препаратов. Международные согласительные документы по лечению крапивницы рекомендуют 4кратное увеличение суточной дозы неседативных антигистаминных препаратов при их неэффективности в стандартных дозах. Данные метаанализа указывают на эффективность омализумаба при хронических индуцированных крапивницах. В перспективе ожидается расширение арсенала генноинженерной биологической терапии хронических индуцированных крапивниц.Chronic inducible urticarias are characterized by the risks of systemic reactions and a significant impairment of patients quality of life. The diagnosis of chronic inducible urticarias relies on the patients history and the challenge tests. A treatment algorithm for the management of chronic inducible urticarias includes nonsedating antihistamines as a firstline treatment. The international guidelines for the management of chronic inducible urticarias recommend updosing of nonsedating antihistamines up to four fold if standard doses are not effective. The metaanalysis suggests the efficacy of omalizumab in chronic inducible urticarias. In the prospect, the novel options of biological therapy for chronic inducible urticarias are expected.

scholarly journals Randomized controlled study of the impact of a participatory patient care plan among primary care patients with common chronic diseases: a one-year follow-up study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nina Tusa ◽  
Hannu Kautiainen ◽  
Pia Elfving ◽  
Sanna Sinikallio ◽  
Pekka Mäntyselkä
Keyword(s):  
Quality Of Life ◽  
Patient Care ◽  
Usual Care ◽  
Care Plan ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Disease Specific

Abstract Backround Chronic diseases and multimorbidity are common in the ageing population and affect the health related quality of life. Health care resources are limited and the continuity of care has to be assured. Therefore it is essential to find demonstrable tools for best treatment practices for patients with chronic diseases. Our aim was to study the influence of a participatory patient care plan on the health-related quality of life and disease specific outcomes related to diabetes, ischemic heart disease and hypertension. Methods The data of the present study were based on the Participatory Patient Care Planning in Primary Care. A total of 605 patients were recruited in the Siilinjärvi Health Center in the years 2017–2018 from those patients who were followed up due to the treatment of hypertension, ischemic heart disease or diabetes. Patients were randomized into usual care and intervention groups. The intervention consisted of a participatory patient care plan, which was formulated in collaboration with the patient and the nurse and the physician during the first health care visit. Health-related quality of life with the 15D instrument and the disease-specific outcomes of body mass index (BMI), low density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1C) and blood pressure were assessed at the baseline and after a one-year follow-up. Results A total of 587 patients with a mean age of 69 years were followed for 12 months. In the intervention group there were 289 patients (54% women) and in the usual care group there were 298 patients (50% women). During the follow-up there were no significant changes between the groups in health-related quality and disease-specific outcomes. Conclusions During the 12-month follow-up, no significant differences between the intervention and the usual care groups were detected, as the intervention and the usual care groups were already in good therapeutic equilibrium at the baseline. Trial registration ClinicalTrials.gov Identifier: NCT02992431. Registered 14/12/2016

scholarly journals Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xin Ye ◽  
Dawei Zhu ◽  
Siyuan Chen ◽  
Xuefeng Shi ◽  
Rui Gong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hearing Loss ◽  
Cost Effectiveness ◽  
Treatment Group ◽  
Hearing Aids ◽  
Control Group ◽  
Chinese Adults ◽  
Community Based ◽  
The Impact

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.

scholarly journals Effectiveness of comprehensive geriatric assessment intervention on quality of life, caregiver burden and length of hospital stay: a systematic review and meta-analysis of randomised controlled trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhongyi Chen ◽  
Zhaosheng Ding ◽  
Caixia Chen ◽  
Yangfan Sun ◽  
Yuyu Jiang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hospital Stay ◽  
Usual Care ◽  
Caregiver Burden ◽  
Length Of Hospital Stay ◽  
Sf 36 ◽  
Subgroup Analyses ◽  
Randomised Controlled ◽  
Meta Analyses

Abstract Background Comprehensive geriatric assessment (CGA) interventions can improve functional ability and reduce mortality in older adults, but the effectiveness of CGA intervention on the quality of life, caregiver burden, and length of hospital stay remains unclear. The study aimed to determine the effectiveness of CGA intervention on the quality of life, length of hospital stay, and caregiver burden in older adults by conducting meta-analyses of randomised controlled trials (RCTs). Methods A literature search in PubMed, Embase, and Cochrane Library was conducted for papers published before February 29, 2020, based on inclusion criteria. Standardised mean difference (SMD) or mean difference (MD) with 95% confidence intervals (CIs) was calculated using the random-effects model. Subgroup analyses, sensitivity analyses, and publication bias analyses were also conducted. Results A total of 28 RCTs were included. Overall, the intervention components common in different CGA intervention models were interdisciplinary assessments and team meetings. Meta-analyses showed that CGA interventions improved the quality of life of older people (SMD = 0.12; 95% CI = 0.03 to 0.21; P = 0.009) compared to usual care, and subgroup analyses showed that CGA interventions improved the quality of life only in participants’ age > 80 years and at follow-up ≤3 months. The change value of quality of life in the CGA intervention group was better than that in the usual care group on six dimensions of the 36-Item Short-Form Health Survey questionnaire (SF-36). Also, compared to usual care, the CGA intervention reduced the caregiver burden (SMD = − 0.56; 95% CI = − 0.97 to − 0.15, P = 0.007), but had no significant effect on the length of hospital stay. Conclusions CGA intervention was effective in improving the quality of life and reducing caregiver burden, but did not affect the length of hospital stay. It is recommended that future studies apply the SF-36 to evaluate the impact of CGA interventions on the quality of life and provide supportive strategies for caregivers as an essential part of the CGA intervention, to find additional benefits of CGA interventions.

Sign in / Sign up

Export Citation Format

Share Document