scholarly journals Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

2021 ◽  
pp. annrheumdis-2020-219091 ◽  
Author(s):  
Gary J Macfarlane ◽  
Marcus Beasley ◽  
Neil Scott ◽  
Huey Chong ◽  
Paul McNamee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Behavioural Therapy ◽  
Short Course ◽  
Life Years ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

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.

A Tablet ‐ Based Intervention for Activating Nursing Home Residents with Dementia: Results from a Cluster-Randomised Controlled Trial

2020 ◽  
Author(s):  
Julie Lorraine O'Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nursing Home ◽  
Nursing Homes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Cluster Randomised Controlled Trial ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background: Non-pharmacological interventions (NPI) can improve cognitive and non-cognitive symptoms in nursing home residents living with dementia. However, delivery of suitable NPI can be challenging in everyday nursing home settings. Internet and communication technologies (ICT) may be promising tools for supporting NPI delivery in nursing homes. Methods: A two-arm cluster-randomised controlled trial was conducted to investigate global and momentary effects of a novel ICT-based NPI for nursing home residents with dementia. Ten nursing homes were randomly allocated to the tablet-based intervention (TBI) or conventional activity sessions (CAS) group (each with five nursing homes) between April 2016 and May 2017. A total of N = 162 participants received either regular TBI (n = 80) or CAS (n = 82) over a period of eight weeks. Linear mixed models were used to analyse group differences regarding the primary outcome apathy (AES-I), and secondary outcomes quality of life (QOL-AD, QUALIDEM), neuropsychiatric (NPI-NH, psychotropic medication) and depressive symptoms (GDS). Ecological Momentary Assessments (EMA) of quality of life were also conducted in both groups before and after each activity session.Results: No significant group difference in the change of apathy (AES-I score, primary outcome) was found post intervention (mean group difference: B = .19; 95% CI: -3.90 to 4.28, p = .93). Regarding secondary outcomes, a reduction of psychotropic medication was found for TBI compared to CAS (B = .42; 95% CI: .15 to .69, p < .01). Further analyses revealed a post-intervention improvement of informant-rated quality of life across both groups (B = 3.69; 95% CI: .68 to 6.69, p = .02). Analysis of EMA also rendered short-term post-session improvements of quality of life in the CAS group (B = .43; 95% CI: .30 to .57, p < .001). Conclusions: These findings suggest that NPI involving individually tailored activities have a beneficial impact on quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, ICT have the potential to support NPI delivery and facilitate regular assessments of fluctuating momentary states in nursing home residents with dementia. Trial registration: The trial was retrospectively registered with the ISRCTN registry (Trial registration number: ISRCTN98947160) on 01/09/2016 http://www.isrctn.com/ISRCTN98947160.

scholarly journals Role of the intelligent exercise rehabilitation management system on adherence of cardiac rehabilitation in patients with coronary heart disease: a randomised controlled crossover study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036720
Author(s):  
Linqi Xu ◽  
Wenji Xiong ◽  
Jinwei Li ◽  
Hongyu Shi ◽  
Meidi Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Coronary Heart Disease ◽  
Usual Care ◽  
Rehabilitation Management ◽  
Exercise Rehabilitation ◽  
Related Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionThe benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors.Methods and analysisWe propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6 weeks and usual care for the last 6 weeks, while patients assigned to group 2 will receive usual care for the first 6 weeks and will use IERMS in the last 6 weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6 weeks and 12 weeks.Ethics and disseminationThis study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences.Trial registration numberChiCTR1900028182; Pre-results.

scholarly journals Frailty and the Kidney Transplant Wait List: Protocol for a Multicenter Prospective Study

2020 ◽  
Vol 7 ◽  
pp. 205435812095743
Author(s):  
Karthik K. Tennankore ◽  
Lakshman Gunaratnam ◽  
Rita S. Suri ◽  
Seychelle Yohanna ◽  
Michael Walsh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Transplant ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Frailty Index ◽  
Wait List ◽  
Relative Hazard ◽  
Risk Of Death ◽  
Secondary Outcomes

Background: Understanding how frailty affects patients listed for transplantation has been identified as a priority research need. Frailty may be associated with a high risk of death or wait-list withdrawal, but this has not been evaluated in a large multicenter cohort of Canadian wait-listed patients. Objective: The primary objective is to evaluate whether frailty is associated with death or permanent withdrawal from the transplant wait list. Secondary objectives include assessing whether frailty is associated with hospitalization, quality of life, and the probability of being accepted to the wait list. Design: Prospective cohort study. Setting: Seven sites with established renal transplant programs that evaluate patients for the kidney transplant wait list. Patients: Individuals who are being considered for the kidney transplant wait list. Measurements: We will assess frailty using the Fried Phenotype, a frailty index, the Short Physical Performance Battery, and the Clinical Frailty Scale at the time of listing for transplantation. We will also assess frailty at the time of referral to the wait list and annually after listing in a subgroup of patients. Methods: The primary outcome of the composite of time to death or permanent wait-list withdrawal will be compared between patients who are frail and those who are not frail and will account for the competing risks of deceased and live donor transplantation. Secondary outcomes will include number of hospitalizations and length of stay, and in a subset, changes in frailty severity over time, change in quality of life, and the probability of being listed. Recruitment of 1165 patients will provide >80% power to identify a relative hazard of ≥1.7 comparing patients who are frail to those who are not frail for the primary outcome (2-sided α = .05), whereas a more conservative recruitment target of 624 patients will provide >80% power to identify a relative hazard of ≥2.0. Results: Through December 2019, 665 assessments of frailty (inclusive of those for the primary outcome and all secondary outcomes including repeated measures) have been completed. Limitations: There may be variation across sites in the processes of referral and listing for transplantation that will require consideration in the analysis and results. Conclusions: This study will provide a detailed understanding of the association between frailty and outcomes for wait-listed patients. Understanding this association is necessary before routinely measuring frailty as part of the wait-list eligibility assessment and prior to ascertaining the need for interventions that may modify frailty. Trial Registration: Not applicable as this is a protocol for a prospective observational study.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

scholarly journals Restarting antiplatelet therapy after spontaneous intracerebral hemorrhage

Neurology ◽  
2018 ◽  
Vol 91 (1) ◽  
pp. e26-e36 ◽  
Author(s):  
Ching-Jen Chen ◽  
Dale Ding ◽  
Thomas J. Buell ◽  
Fernando D. Testai ◽  
Sebastian Koch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intracerebral Hemorrhage ◽  
Functional Outcomes ◽  
Primary Outcome ◽  
Modified Rankin Scale ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Secondary Outcomes

ObjectiveTo compare the functional outcomes and health-related quality of life metrics of restarting vs not restarting antiplatelet therapy (APT) in patients presenting with intracerebral hemorrhage (ICH) in the ERICH (Ethnic/Racial Variations of Intracerebral Hemorrhage) study.MethodsAdult patients aged 18 years and older who were on APT before ICH and were alive at hospital discharge were included. Patients were dichotomized based on whether or not APT was restarted after hospital discharge. The primary outcome was a modified Rankin Scale score of 0–2 at 90 days. Secondary outcomes were excellent outcome (modified Rankin Scale score 0–1), mortality, Barthel Index, and health status (EuroQol–5 dimensions [EQ-5D] and EQ-5D visual analog scale scores) at 90 days.ResultsThe APT and no APT cohorts comprised 127 and 732 patients, respectively. Restarting APT was associated with lower rates of good functional outcome (36.5% vs 40.8%; p = 0.021) and lower Barthel Index scores at 90 days (p = 0.041). The 2 cohorts were then matched in a 1:1 ratio, and the matched cohorts each comprised 107 patients. No difference in primary outcome was observed between restarting vs not restarting APT (35.5% vs 43.9%; p = 0.105). There were also no differences between the secondary outcomes of the 2 cohorts.ConclusionRestarting APT in patients with ICH of mild to moderate severity after acute hospitalization is not associated with worse functional outcomes or health-related quality of life at 90 days. In patients with significant cardiovascular risk factors who experience an ICH, restarting APT remains the decision of the treating practitioner.

scholarly journals Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Acupuncture Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

scholarly journals Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050627
Author(s):  
Domenico Giacco ◽  
Agnes Chevalier ◽  
Megan Patterson ◽  
Thomas Hamborg ◽  
Rianna Mortimer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Social Activities ◽  
Social Contacts ◽  
Coaching Intervention ◽  
Randomised Controlled

IntroductionPeople with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.Methods and analysisA structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20–29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.Ethics and disseminationNational Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.Trial registration numberISRCTN15815862.

scholarly journals Yoga, cognitive–behavioural therapy versus education to improve quality of life and reduce healthcare costs in people with endometriosis: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046603
Author(s):  
Antonina Mikocka-Walus ◽  
Marilla Druitt ◽  
Melissa O'Shea ◽  
David Skvarc ◽  
Jennifer J Watts ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
System Perspective ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Weekly Group

IntroductionEndometriosis is a debilitating chronic inflammatory condition highly burdensome to the healthcare system. The present trial will establish the efficacy of (1) yoga and (2) cognitive–behavioural therapy (CBT), above (3) education, on quality of life, biopsychosocial outcomes and cost-effectiveness.Methods and analysisThis study is a parallel randomised controlled trial. Participants will be randomly allocated to yoga, CBT or education. Participants will be English-speaking adults, have a diagnosis of endometriosis by a qualified physician, with pain for at least 6 months, and access to internet. Participants will attend 8 weekly group CBT sessions of 120 min; or 8 weekly group yoga sessions of 60 min; or receive weekly educational handouts on endometriosis. The primary outcome measure is quality of life. The analysis will include mixed-effects analysis of variance and linear models, cost–utility analysis from a societal and health system perspective and qualitative thematic analysis.Ethics and disseminationEnrolment in the study is voluntary and participants can withdraw at any time. Participants will be given the option to discuss the study with their next of kin/treating physician. Findings will be disseminated via publications, conferences and briefs to professional organisations. The University’s media team will also be used to further disseminate via lay person articles and media releases.Trial registration numberACTRN12620000756921p; Pre-results.

Sign in / Sign up

Export Citation Format

Share Document