scholarly journals Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026039 ◽  
Author(s):  
Julia Frost ◽  
Jennifer Wingham ◽  
Nicky Britten ◽  
Colin Greaves ◽  
Charles Abraham ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Intervention Fidelity ◽  
Reduced Ejection Fraction ◽  
Randomised Controlled

ObjectiveTo identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.DesignMixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).SettingFour centres in the UK (Birmingham, Cornwall, Gwent and York).ParticipantsPeople with heart failure with reduced ejection fraction (HFrEF) and their caregivers.MethodsThe REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.Outcome measuresQuantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.ResultsIntervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.ConclusionsBy combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.Trial registration numberISRCTN25032672; Pre-results.

scholarly journals Stress Management in Elementary School Students: a Pilot Randomised Controlled Trial

2021 ◽  
Vol 26 (1) ◽  
pp. e976
Author(s):  
Katerina Sofianopoulou ◽  
Flora Bacopoulou ◽  
Dimitrios Vlachakis ◽  
Ioulia Kokka ◽  
Evaggelos Alexopoulos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Elementary School ◽  
Randomised Controlled Trial ◽  
Elementary School Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
School Students ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Research has shown that stress experiences begin in early stages of life. Stress management techniques have appeared to be beneficial for the development or enhancement of stress coping skills. The aim of this pilot randomised controlled trial was to assess the effect of a 12-week intervention, comprising training in diaphragmatic breathing and progressive muscular relaxation, on elementary school students’ stress levels. Outcomes on the quality of life and behavioural aspects of the students were also assessed. Standardised questionnaires were administered at baseline and after the 12-week intervention program. Fifty-two children aged 10 to 11 years were randomly assigned to intervention (n=24) and control groups (n=28). Children of the intervention group demonstrated lower levels of stress (in all three subscales of lack of well-being, distress, and lack of social support) and improved aspects of quality of life (physical, emotional, and school functioning). No significant differences were observed regarding the examined behavioural dimensions, in the intervention group. Larger randomised controlled trials with follow-up evaluations are needed to ascertain the positive outcomes of such programs on elementary school children.

scholarly journals e-Monitoring of Asthma Therapy to Improve Compliance in children (e-MATIC): a randomised controlled trial

2016 ◽  
Vol 48 (3) ◽  
pp. 758-767 ◽  
Author(s):  
Erwin C. Vasbinder ◽  
Lucas M.A. Goossens ◽  
Maureen P.M.H. Rutten-van Mölken ◽  
Brenda C.M. de Winter ◽  
Liset van Dijk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Quality ◽  
Asthma Exacerbations ◽  
Sms Reminders ◽  
Randomised Controlled

Real-time medication monitoring (RTMM) is a promising tool for improving adherence to inhaled corticosteroids (ICS), but has not been sufficiently tested in children with asthma. We aimed to study the effects of RTMM with short message service (SMS) reminders on adherence to ICS, asthma control, asthma-specific quality of life and asthma exacerbation rate; and to study the associated cost-effectiveness.In a multicentre, randomised controlled trial, children (aged 4–11 years) using ICS were recruited from five outpatient clinics and were given an RTMM device for 12 months. The intervention group also received tailored SMS reminders, sent only when a dose was at risk of omission. Outcome measures were adherence to ICS (RTMM data), asthma control (childhood asthma control test questionnaire), quality of life (paediatric asthma quality of life questionnaire) and asthma exacerbations. Costs were calculated from a healthcare and societal perspective.We included 209 children. Mean adherence was higher in the intervention group: 69.3%versus57.3% (difference 12.0%, 95% CI 6.7%–17.7%). No differences were found for asthma control, quality of life or asthma exacerbations. Costs were higher in the intervention group, but this difference was not statistically significant.RTMM with tailored SMS reminders improved adherence to ICS, but not asthma control, quality of life or exacerbations in children using ICS for asthma.

scholarly journals Mindful gratitude journaling: psychological distress, quality of life and suffering in advanced cancer: a randomised controlled trial

2021 ◽  
pp. bmjspcare-2021-003068
Author(s):  
Ting Ting Tan ◽  
Maw Pin Tan ◽  
Chee Loong Lam ◽  
Ee Chin Loh ◽  
David Paul Capelle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Randomised Controlled

ContextNumerous studies have shown that gratitude can reduce stress and improve quality of life.ObjectiveOur study aimed to examine the effect of mindful gratitude journaling on suffering, psychological distress and quality of life of patients with advanced cancer.MethodsWe conducted a parallel-group, blinded, randomised controlled trial at the University of Malaya Medical Centre, Malaysia. Ninety-two adult patients with advanced cancer, and an overall suffering score ≥4/10 based on the Suffering Pictogram were recruited and randomly assigned to either a mindful gratitude journaling group (N=49) or a routine journaling group (N=43).ResultsAfter 1 week, there were significant reductions in the overall suffering score from the baseline in both the intervention group (mean difference in overall suffering score=−2.0, 95% CI=−2.7 to −1.4, t=−6.125, p=0.000) and the control group (mean difference in overall suffering score=−1.6, 95% CI=−2.3 to −0.8, t=−4.106, p=0.037). There were also significant improvements in the total Hospital Anxiety and Depression Scale score (mean difference=−3.4, 95% CI=−5.3 to −1.5, t=−3.525, p=0.000) and the total Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being score (mean difference=7.3, 95% CI=1.5 to 13.1, t=2.460, p=0.014) in the intervention group after 7 days, but not in the control group.ConclusionThe results provide evidence that 7 days of mindful gratitude journaling could positively affect the state of suffering, psychological distress and quality of life of patients with advanced cancer.Trial registration numberThe trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1261800172191) and conducted in accordance with the Declaration of Helsinki.

Understanding implementation factors and participant experiences of a cluster randomised controlled trial to prevent falls among older Aboriginal people: a process evaluation protocol

2021 ◽  
pp. injuryprev-2020-043980
Author(s):  
Rona Macniven ◽  
Julieann Coombes ◽  
Roland Wilson ◽  
Aaron Simon ◽  
Tamara Mackean ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Aboriginal People ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Mixed Methods Design ◽  
Programme Implementation ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionProcess evaluations examining programme implementation are often conducted in conjunction with effectiveness studies. Their inclusion in studies with Aboriginal participants can give an understanding of programme delivery in Aboriginal community contexts. The Ironbark: Standing Strong and Tall programme was codesigned with Aboriginal communities and includes exercise and facilitated ‘yarning’ discussion about fall risk and prevention strategies. The programme pilot showed favourable outcomes and acceptability for Aboriginal people aged 45 years and over. The Ironbark: Standing Strong and Tall programme is now being compared with a ‘Healthy Community’ programme in a cluster randomised controlled trial within Aboriginal health and community services. An embedded process evaluation aims to explore relationships between participation and programme outcomes and the quality of programme implementation.Methods and analysisThe process evaluation will use a mixed methods design, guided by Indigenous research methodology. It will evaluate quantitative data (number of completed sessions, site coaching checklist tool, participant and facilitator questionnaire data and a participant habit formation scale), as well as qualitative data (open-ended responses from project and site staff and semistructured interviews using yarning with study participants and site managers). A programme logic model was developed to explain the intended inputs, activities, outputs and outcomes, which guided this process evaluation design.ConclusionThis process evaluation of a fall prevention programme for older Aboriginal people using a mixed methods design and data triangulation will allow for a comprehensive understanding of study findings. Multiple study sites allow for generalisability of findings and exploration of variation across sites.Trial registration numberACTRN12619000349145.

scholarly journals Effect of occupation-based interventions in patients with haematopoietic malignancies undergoing chemotherapy: A pilot randomised controlled trial

2018 ◽  
Vol 31 (2) ◽  
pp. 97-105
Author(s):  
Akira Sagari ◽  
Yuta Ikio ◽  
Nobuko Imamura ◽  
Kayoko Deguchi ◽  
Toko Sakai ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Decision Making ◽  
Randomised Controlled Trial ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Background/objective Chemotherapy for cancer negatively affects activities of daily living and quality of life. This study aimed to validate and compare the efficacy of two different interventions in patients with haematopoietic malignancies undergoing chemotherapy: (1) occupation-based interventions, designed using the Aid for Decision-making in Occupation Choice (ADOC) (an iPAD application) and (2) impairment-based interventions. ADOC helps promote decision-making during activities and participation in occupation-based goal setting. The impairment-based intervention group served as the comparison group and underwent impairment-based interventions focusing on dysfunction. Methods In this single-blinded pilot randomised controlled trial, 19 participants received an occupation-based intervention (n = 9) or an impairment-based intervention (n = 10). The treatment period comprised two sessions. Recruitment, compliance and outcome completion rates were calculated for the study. Effect sizes were examined for outcomes regarding physical performance, instrumental activities of daily living and quality of life as evaluated by a blinded assessor. Results In this study, 24.8% (28/113) of the eligible patients with haematopoietic malignancies were enrolled, and 67.9% (19/28) of these were retained up to the post-assessment stage. Recruitment (25%) and compliance (68%) rates were satisfactory. The Functional Assessment of Cancer Therapy-General emotional well-being and total scores were significantly higher for the occupation-based intervention group than for the impairment-based intervention group (both p < 0.05; d = 0.54, d = 0.51, respectively). Other outcomes showed no significant differences. Conclusion Occupation-based interventions designed using the ADOC application were useful for patients with haematopoietic malignancies.

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