scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Effectiveness of a peer-mediated educational intervention in improving general practitioner diagnostic assessment and management of dementia: a cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021125 ◽  
Author(s):  
Dimity Pond ◽  
Karen Mate ◽  
Nigel Stocks ◽  
Jane Gunn ◽  
Peter Disler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
General Practices ◽  
Randomised Controlled

ObjectiveTest effectiveness of an educational intervention for general practitioners (GPs) on quality of life and depression outcomes for patients.DesignDouble-blind, cluster randomised controlled trial.SettingGeneral practices in Australia between 2007 and 2010.ParticipantsGeneral practices were randomly allocated to the waitlist (n=37) or intervention (n=66) group, in a ratio of 1:2. A total of 2030 (1478 intervention; 552 waitlist) community-dwelling participants aged 75 years or older were recruited via 168 GPs (113 intervention; 55 waitlist).InterventionsA practice-based academic detailing intervention led by a peer educator that included: (1) training in use of the GP assessment of cognition dementia screening instrument; (2) training in diagnosis and management based on Royal Australian College of General Practitioners Dementia Guidelines; (3) addressing GPs’ barriers to dementia diagnosis; and (4) a business case outlining a cost-effective dementia assessment approach.Outcome measuresPrimary outcome measures were patient quality of life and depression; secondary outcome measures were: (1) sensitivity and specificity of GP identification of dementia; (2) referral to medical specialists and/or support services; (3) patient satisfaction with care; and (4) carer quality of life, depression and satisfaction with care.ResultsThe educational intervention had no significant effect on patient quality of life or depression scores after 12 months. There were however improvements in secondary outcome measures including sensitivity of GP judgement of dementia (p=0.002; OR 6.0, 95% CI 1.92 to 18.73), satisfaction with GP communication for all patients (p=0.024; mean difference 2.1, 95% CI 0.27 to 3.93) and for patients with dementia (p=0.007; mean difference 7.44, 95% CI 2.02 to 12.86) and enablement of carers (p=0.0185; mean difference 24.77, 95% CI 4.15 to 45.40).ConclusionPractice-based academic detailing did not improve patient quality of life or depression scores but did improve detection of dementia in primary care and patient satisfaction with GP communication.Trial registration numberACTRN12607000117415; Pre-results.

scholarly journals Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017393 ◽  
Author(s):  
Marc R Nickels ◽  
Leanne M Aitken ◽  
James Walsham ◽  
Adrian G Barnett ◽  
Steven M McPhail
Keyword(s):  
Quality Of Life ◽  
Critical Illness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Hospital Discharge ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Surgical Intensive Care Unit ◽  
Randomised Controlled

IntroductionIn-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown.Methods and analysisA single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) a usual care group or (2) a group that receives usual care and additional in-bed cycling sessions. The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire.Ethics and disseminationAppropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.Trial registration numberThis trial has been prospectively registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12616000948493); Pre-results.

scholarly journals Individual cognitive stimulation therapy for people with intellectual disability and dementia: protocol of a feasibility randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e022136 ◽  
Author(s):  
Afia Ali ◽  
Emma Brown ◽  
Aimee Spector ◽  
Elisa Aguirre ◽  
Angela Hassiotis
Keyword(s):  
Quality Of Life ◽  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Cognitive Stimulation ◽  
Secondary Outcome ◽  
Cognitive Stimulation Therapy ◽  
Randomised Controlled

IntroductionCognitive stimulation therapy (CST) is a psychosocial intervention for dementia. Group CST is effective in reducing cognitive decline and improving quality of life in patients with dementia. There is some evidence that individual CST (iCST) may be beneficial in reducing cognitive decline. People with intellectual disability (ID) have an increased risk of dementia. However, there are no published studies of CST in people with ID and dementia. This protocol describes the feasibility and acceptability of a randomised controlled trial of iCST delivered by carers to people with ID and dementia, compared with treatment as usual (TAU). The results of this study will inform the design of a future definitive randomised controlled trial.Methods and analysisThe iCST intervention has been adapted for this trial. Forty dyads (individuals with ID and their carer) will be randomised to either iCST or TAU. The manualised intervention comprises 40 iCST sessions delivered by a carer for 30 min, twice a week, over 20 weeks. The primary outcome will be process measures assessing the feasibility and acceptability of the intervention and trial procedures. The secondary outcome will be changes in the scores of outcome measures (cognition, functional ability and quality of life in individuals with ID, and caregiver burden, competence in managing dementia, and anxiety and depression in carers). Data will be collected at baseline, 11 weeks and at 21 weeks. A process evaluation will examine adherence to iCST and will include qualitative interviews with participants to identify aspects of the intervention that were or were not successful.Ethics and disseminationThe study has received ethical approval. The results of the study will be presented at conferences and submitted to a peer reviewed journal.Trial registration numberISRCTN18312288; Pre-results.

scholarly journals Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025578
Author(s):  
Leigh Hale ◽  
Tim Stokes ◽  
Bonnie Scarth ◽  
Ramakrishnan Mani ◽  
Trudy Sullivan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Education Programme ◽  
Secondary Outcome ◽  
Randomised Controlled

IntroductionType 2 diabetes is common in Māori and Pacific peoples and in those living in areas of high socioeconomic deprivation in New Zealand (NZ). People with type 2 diabetes often have multimorbidity, which makes their diabetes management more complex. The Diabetes Community Exercise and Education Programme (DCEP) is an interprofessional, patient-centred, whānau (family)-supported package of care specifically developed to engage with Māori and Pacific people and those living in deprived areas. We have previously demonstrated the feasibility and acceptability of the DCEP. This study aims to determine the effectiveness and cost-effectiveness of the DCEP through a pragmatic randomised controlled trial (RCT).Methods and analysis220 adults (age ≥35 years) with type 2 diabetes will be recruited from general practices in the lower South Island of NZ (Dunedin and Invercargill) to participate in an RCT. Participants will be randomised to intervention (DCEP) and control (usual care) groups. The DCEP participants will have their exercise goals agreed on with a physiotherapist and nurse and will attend two 90 min exercise and education sessions per week for 12 weeks. The primary outcome measure is blood glucose control (glycated haemoglobin). Secondary outcome measures include quality of life assessed using the Audit of Diabetes-Dependent Quality of Life questionnaire. Data will be collected at four time points: baseline, end of the 12-week intervention (3 months), 6 months postintervention (9 months) and 12 months after the intervention ends (15 months). We will also conduct a cost-effectiveness analysis and a qualitative process evaluation.Ethics and disseminationThe study has been approved by the Health and Disability Ethics Committee, Ministry of Health (HDEC17/CEN/241/AM01). A key output will be the development of an evidence-based training package to facilitate implementation of the DCEP in other NZ regions.Trial registration numberACTRN 12617001624370 p; Pre-results.

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046600
Author(s):  
Anne-Marie Hill ◽  
Rachael Moorin ◽  
Susan Slatyer ◽  
Christina Bryant ◽  
Keith Hill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Care Recipient ◽  
Care At Home ◽  
Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

scholarly journals E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041548
Author(s):  
Cristian Ochoa-Arnedo ◽  
Joan Carles Medina ◽  
Aida Flix-Valle ◽  
Dimitra Anastasiadou
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Emotional Distress ◽  
Controlled Trial ◽  
Psychosocial Care ◽  
Cost Utility ◽  
Psychosocial Services ◽  
Randomised Controlled

IntroductionPsychosocial interventions for patients with breast cancer (BC) have demonstrated their effectiveness at reducing emotional distress and improving quality of life. The current digitisation of screening, monitoring and psychosocial treatment presents the opportunity for a revolution that could improve the quality of care and reduce its economic burden. The objectives of this study are, first, to assess the effectiveness of an e-health platform with integrated and stepped psychosocial services compared with usual psychosocial care, and second, to examine its cost–utility.Methods and analysisThis study is a multicentre randomised controlled trial with two parallel groups: E-health intervention with integrated and stepped psychosocial services vs usual psychosocial care. An estimated sample of 338 patients with BC in the acute survival phase will be recruited from three university hospitals in Catalonia (Spain) and will be randomly assigned to one of two groups. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include number of clinical cases detected, waiting time from detection to psychosocial intervention and proportion of cases successfully treated in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth, treatment adherence and therapeutic alliance. Secondary outcomes will include the acceptability of the platform, patients’ satisfaction and usability. For the cost–utility analysis, we will assess quality-adjusted life years and costs related to healthcare utilisation, medication use and adherence, work absenteeism and infrastructure-related and transport-related costs.Ethics and disseminationThis study was approved by the Ethics committee of the Institut Català d’Oncologia network in Hospitalet, Spain. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences among the scientific community, workshops with patients and media press releases.Trial registration numberOnline Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors (ICOnnectat-B),NCT04372459.

scholarly journals Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035337 ◽  
Author(s):  
Joost Wolfs ◽  
Jop Beugels ◽  
Merel Kimman ◽  
Andrzej A Piatkowski de Grzymala ◽  
Esther Heuts ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Lymph Node ◽  
Randomised Controlled Trial ◽  
Conservative Treatment ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Breast Cancer Treatment ◽  
Randomised Controlled

IntroductionEarly breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.Methods and analysisA multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.Ethics and disseminationThe study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.Trial registration numberNCT02790021; Pre-results.

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