Development, assessment, and monitoring of audiologic treatment fidelity in the aging and cognitive health evaluation in elders (ACHIEVE) randomised controlled trial

IntroductionFatigue is a pervasive symptom of end-stage renal disease (ESRD) that is associated with low quality of life, disability and mortality, and has been identified as a top research priority by patients. We developed a personalised, web-supported educational programme (the Personal Energy Planning (PEP) programme) to teach people with ESRD to use energy management to manage fatigue. Preliminary studies have demonstrated positive effects on fatigue and life participation (ie, the ability to participate in valued day-to-day activities), which justifies the need for a randomised controlled trial (RCT) to better understand the efficacy of the programme. The objectives of the pilot RCT are to estimate RCT eligibility, recruitment and attrition rates, to inform the primary outcome measure and sample size for the RCT and to evaluate treatment fidelity among programme administrators.Methods and analysisA parallel-arm, 1:1 pilot RCT will be conducted at four in-centre haemodialysis units in Calgary, Alberta, Canada. People on haemodialysis who report moderate or severe fatigue on the Fatigue Severity Scale, and meet other study eligibility criteria, will be invited to participate. Consenting participants will be randomised to undergo the 7–9 week ‘PEP’ programme or an active control, and followed for 12 weeks after the programme concludes. Information on eligibility, recruitment and attrition rates will be collected, and questionnaires assessing fatigue and life participation will be administered preintervention, midintervention, immediately postintervention and 12 weeks postintervention. Analyses will include calculation of eligibility, recruitment and attrition rates; power considerations for the full-scale RCT and evaluation of treatment fidelity of programme administrators.Ethics and disseminationRisks associated with this study are minor. Patients may experience emotional discomfort while filling out study questionnaires. They will be advised to skip any questions that make them uncomfortable. Potential benefits of participating include any benefit derived from the study intervention, and contributing to research that may benefit people with kidney disease in the future. Trial results will be disseminated via publication in an academic journal and presentation at academic conferences. The study has been approved by the Conjoint Health Research Ethics Board at the University of Calgary (ID #18-1657).

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Evaluating ‘Enhancing Pragmatic Language skills for Young children with Social communication impairments’ (E-PLAYS): a feasibility cluster-randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00724-9 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Suzanne Murphy ◽

Victoria Joffe ◽

Louisa Donald ◽

Jessica Radley ◽

Sailaa Sunthararajah ◽

...

Keyword(s):

Health Economic ◽

Randomised Controlled Trial ◽

Social Communication ◽

Teaching Assistants ◽

Controlled Trial ◽

Treatment Fidelity ◽

Cluster Randomised Controlled Trial ◽

Speech And Language ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background This article reports the results from a feasibility study of an intervention (‘E-PLAYS’) aimed at supporting children who experience difficulties with social communication. E-PLAYS is based around a dyadic computer game, which aims to develop collaborative and communication skills. A pilot study found that when E-PLAYS was delivered by researchers, improvements on communication test scores and on collaborative behaviours were observed. The aim of this study was to ascertain the feasibility of running a full-scale trial to test the effectiveness of E-PLAYS in a National Health Service (NHS) setting with delivery by speech and language therapists and teaching assistants. Methods The study was a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with a treatment as usual control arm. Data relating to recruitment and retention, treatment fidelity, acceptability to participants, suitability of outcomes and feasibility of collecting health economic measures and of determining cost-effectiveness were collected. Speech and language therapists selected suitable children (ages 4–7 years old) from their caseload. E-PLAYS intervention (experimental group) was then delivered by teaching assistants overseen by speech and language therapists. The control group received usual care. Assessments included blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and non-blinded parent-reported use of health and education resources and quality of life. Results Planned recruitment was for 70 children, in the event, 50 children were recruited which was sufficient for feasibility purposes. E-PLAYS was very highly rated by children, teaching assistants and speech and language therapists and treatment fidelity did not pose any issues. We were able to collect health economic data which suggests that E-PLAYS would be a low-cost intervention. Conclusion Based on recruitment, retention and adherence rates and our outcome measures, a full-scale randomised controlled trial estimated appears feasible and warranted to assess the effectiveness of E-PLAYS for use by the NHS and schools. Trial registration ISRCTN 14818949 (retrospectively registered).

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