scholarly journals Effectiveness of a brief positive skills intervention to improve psychological adjustment in patients with end-stage kidney disease newly initiated on haemodialysis: protocol for a randomised controlled trial (HED-Start)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e053588
Author(s):  
Konstadina Griva ◽  
Jace Ming Xuan Chia ◽  
Zack Zhong Sheng Goh ◽  
Yen Peng Wong ◽  
Job Loei ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Usual Care ◽  
Life Skills ◽  
Controlled Trial ◽  
Self Management ◽  
End Stage Kidney Disease ◽  
Research Activities ◽  
Randomised Controlled ◽  
End Stage

IntroductionInitiation onto haemodialysis is a critical transition that entails multiple psychosocial and behavioural demands that can compound mental health burden. Interventions guided by self-management and cognitive–behavioural therapy to improve distress have been variably effective yet are resource-intensive or delivered reactively. Interventions with a focus on positive affect for patients with end-stage kidney disease are lacking. This study will seek (1) to develop a positive life skills intervention (HED-Start) combining evidence and stakeholder/user involvement and (2) evaluate the effectiveness of HED-Start to facilitate positive life skills acquisition and improve symptoms of distress and adjustment in incident haemodialysis patients.Methods and analysisThis is a single/assessor-blinded randomised controlled trial (RCT) to compare HED-Start to usual care. In designing HED-Start, semistructured interviews, a codesign workshop and an internal pilot will be undertaken, followed by a two-arm parallel RCT to evaluate the effectiveness of HED-Start. A total of 148 incident HD patients will be randomised using a 1:2 ratio into usual care versus HED-Start to be delivered in groups by trained facilitators between January 2021 and September 2022. Anxiety and depression will be the primary outcomes; secondary outcomes will be positive and negative affect, quality of life, illness perceptions, self-efficacy, self-management skills, benefit finding and resilience. Assessments will be taken at 2 weeks prerandomisation (baseline) and 3 months postrandomisation (2 weeks post-HED-Start completion). Primary analyses will use an intention-to-treat approach and compare changes in outcomes from baseline to follow-up relative to the control group using mixed-effect models.Ethics and disseminationEthics approval was obtained from Nanyang Technological University Institutional Review Board (IRB-2019-01-010). Written informed consent will be obtained before any research activities. Trial results will be disseminated via publications in peer-reviewed journals and conference presentations and will inform revision(s) in renal health services to support the transition of new patients to haemodialysis.Trial registration numberNCT04774770.

scholarly journals Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

2020 ◽  
Vol 6 (4) ◽  
pp. 00460-2020
Author(s):  
Michael G. Crooks ◽  
Jack Elkes ◽  
William Storrar ◽  
Kay Roy ◽  
Mal North ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Self Management ◽  
Open Label ◽  
Management Interventions ◽  
Randomised Controlled ◽  
The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

scholarly journals Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS)

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033520 ◽  
Author(s):  
Shilpa Patel ◽  
Felix Achana ◽  
Dawn Carnes ◽  
Sandra Eldridge ◽  
David R Ellard ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Chronic Headache ◽  
Controlled Trial ◽  
Self Management ◽  
Management Support ◽  
Support Programme ◽  
Chronic Headaches ◽  
Randomised Controlled

IntroductionChronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysisChronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and disseminationThis trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration numberISRCTN79708100.

scholarly journals Home-based exercise for people living with frailty and chronic kidney disease: A mixed-methods pilot randomised controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0251652
Author(s):  
Andrew C. Nixon ◽  
Theodoros M. Bampouras ◽  
Helen J. Gooch ◽  
Hannah M. L. Young ◽  
Kenneth W. Finlayson ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Usual Care ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Home Based ◽  
Pilot Rct ◽  
Randomised Controlled

Background Frailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD. Methods Participants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability. Results Six hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence. Conclusions This pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD. Trial registration ISRCTN87708989; https://clinicaltrials.gov/.

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