Full Randomised Controlled Trial Research Articles

Feasibility randomised controlled trial of face-to-face counselling and mobile phone messages compared to usual care for smokeless tobacco cessation in Indian primary care: Project CERTAIN.

Smokeless tobacco (SLT) use in low- and middle-income countries (LMICs) has adverse health consequences. We hypothesize that it is feasible to test an intervention of mobile phone messages and face-to-face counselling session for SLT cessation in India. We conducted an exploratory, individual parallel two group, randomised controlled trial (RCT), with baseline -and end-point (three months from randomisation) assessments in urban primary health centres in Odisha, India. A total of 250 current (i.e., users in the last three months) SLT users or dual users (i.e., smokers and SLT users) were recruited to the trial (125 in each group). Participants were randomised to either routine care, face-to-face counselling, and reminder mobile messages or routine care only. The primary outcomes were to assess the feasibility of running a full RCT including recruitment, compliance, and retention. A total seven (77.8%) out of nine primary care centres took part in the trial. Out of the 315 SLT users invited to participate, 250 provided consent and were randomised [79.4% (95% CI: 74.5, 83.7)]. Out of the 250 randomised SLT users, 238 [95% (95% CI: 91.8, 97.5)] were followed up at three months (117 in the intervention group and 121 in the control group). Of the participants in the intervention group, 74 (63.8%) reported that they received the mobile messages. This exploratory trial demonstrated the feasibility of delivering and evaluating an intervention of mobile phone messages and face-to-face counselling for SLT users in Indian primary care in a full randomised trial. This study found that combining mobile messages with face-to-face counselling for smokeless tobacco users visiting primary health care settings in India is feasible in terms of recruitment of users, compliance with the intervention, and retention of study participants within the trial.The biochemically verified smokeless tobacco abstinence rate was higher in the intervention group compared with the control groupThere was poor agreement between self-reported tobacco cessation and the measured salivary cotinine in smokeless tobacco users.The findings support the feasibility and acceptability of the intervention signalling the need for a larger clinical trial to test effectiveness of the intervention.

Quality of reporting inflammatory bowel disease randomised controlled trials: a systematic review

ObjectiveOur objective was to perform a systemic evaluation of the risk of bias in randomised controlled trial (RCT) reports published on inflammatory bowel disease (IBD).DesignWe assessed the risk of bias...

High-Flow Humidified Oxygen as an Early Intervention in Children With Acute Severe Asthma: Protocol for a Feasibility Randomized Controlled Trial.

Acute severe asthma (ASA) is a leading cause of hospital attendance in children. Standard first-line therapy consists of high-dose inhaled bronchodilators plus oral corticosteroids. Treatment for children who fail to respond to first-line therapy is problematic: the use of intravenous agents is inconsistent, and side effects are frequent. High-flow humidified oxygen (HiFlo) is widely used in respiratory conditions and is increasingly being used in ASA, but with little evidence for its effectiveness. A well-designed, adequately powered randomized controlled trial (RCT) of HiFlo therapy in ASA is urgently needed, and feasibility data are required to plan such an RCT. In this study, we describe the protocol for a feasibility study designed to fill this knowledge gap. This study aims to establish whether a full RCT of early HiFlo therapy in children with ASA can be conducted successfully and safely, to establish whether recruitment using deferred consent is practicable, and to define appropriate outcome measures and sample sizes for a definitive RCT. The underlying hypothesis is that early HiFlo therapy in ASA will reduce the need for more invasive treatments, allow faster recovery and discharge from hospital, and in both these ways reduce distress to children and their families. We conducted a feasibility RCT with deferred consent to assess the use of early HiFlo therapy in children aged 2 to 11 years with acute severe wheeze not responding to burst therapy (ie, high-dose inhaled salbutamol with or without ipratropium). Children with a Preschool Respiratory Assessment Measure score ≥5 after burst therapy were randomized to commence HiFlo therapy or follow standard care. The candidate primary outcomes assessed were treatment failure requiring escalation and time to meet hospital discharge criteria. Patient and parent experiences were also assessed using questionnaires and telephone interviews. The trial was opened to recruitment in February 2020 but was paused for 15 months owing to the COVID-19 pandemic. The trial was reopened at the lead site in July 2021 and opened at the other 3 sites from August to December 2022. Recruitment was completed in June 2023. This feasibility RCT of early HiFlo therapy in children with ASA recruited to the target despite major disturbances owing to the COVID-19 pandemic. The data are currently being analyzed and will be published separately. International Standard Randomised Controlled Trial Number Registry ISRCTN78297040; https://www.isrctn.com/ISRCTN78297040. DERR1-10.2196/54081.

Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK

BackgroundA serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression in studies undertaken in Australasia. However, SPARX has never been trialled in the United Kingdom (UK), and there have been issues relating to low engagement when it has been used in a real-world context.AimsTo conduct the first pilot and feasibility randomised controlled trial (RCT) in England to explore the use of SPARX in different settings. The trial will explore whether SPARX supported by an e-coach (assistant psychologists) improves adherence and engagement compared with self-directed (i.e. self-help) use. The trial results will be used to inform the optimal mode of delivery (SPARX supported vs. SPARX self-directed), to calculate an appropriate sample size for a full RCT, and to decide which setting is most suitable.MethodsFollowing consultation with young people to ensure study suitability/appropriateness, a total of 120 adolescents (11–19 years) will be recruited for this three-arm study. Adolescents recruited for the study across England will be randomised to receive either SPARX with human support (from an e-coach), self-directed SPARX, or a waitlist control group. Assessments will be conducted online at baseline, week 4, and 8–10-week post-randomisation. The assessments will include measures which capture demographic, depression (Patient Health Questionnaire modified for adolescents [PHQ-A]) and anxiety (Revised Child Anxiety and Depression Scale [RCADS]) symptomatology, and health-related quality-of-life data (EQ-5D-Y and proxy version). Analyses will be primarily descriptive. Qualitative interviews will be undertaken with a proportion of the participants and clinical staff as part of a process evaluation, and the qualitative data gathered will be thematically analysed. Finally, feasibility data will be collected on recruitment details, overall study uptake and engagement with SPARX, participant retention, and youth-reported acceptability of the intervention.DiscussionThe findings will inform the design of a future definitive RCT of SPARX in the UK. If the subsequent definitive RCT demonstrates that SPARX is effective, then an online serious game utilising CBT principles ultimately has the potential to improve the provision of care within the UK’s health services if delivered en masse.Trial registrationISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

The Adhesive Capsulitis Corticosteroid and Dilation (ACCorD) randomized controlled trial.

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral. We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone. Feasibility outcomes include the rate of randomization as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. This study has involved patients and the public in the trial design, dissemination methods, and how to include groups who are underserved by research. We will disseminate findings among musculoskeletal clinicians via the British Orthopaedic Association, the Chartered Society of Physiotherapy, the Royal College of Radiologists, and the Royal College of General Practitioners. To ensure wide reach we will communicate findings through our established network of charities and organizations, in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in northeast London). If a full trial is shown to be feasible, we will seek additional National Institute for Health and Care Research funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder.

Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study).

Attention Deficit Hyperactivity Disorder (ADHD) has a global mean prevalence of 5%. Cognitive Training (CT) and Mindfulness-Based Interventions (MBIs) have shown promising results in managing ADHD symptoms, but they are not its Treatment-As-Usual (TAU). The NeuroMind Study aims to evaluate the preliminary effectiveness and feasibility of three interventions: Mindfulness for Health (M4H), CT using the NeuronUP® platform (CT), and a combination of both, Mindfulness Cognitive Training (MCT). There is empirical evidence supporting the effectiveness of the M4H and NeuronUP® platform; however, this study explores for the first time the effectiveness of MCT and CT, as well as the integration of M4H into TAU. The objectives of this 5-month Randomized Controlled Trial (RCT) are: (1) To analyze the preliminary effectiveness and feasibility of M4H, CT or a combination of both (MCT) added to TAU for children with ADHD; (2) To evaluate the role of psychological process variables (mindfulness and emotional regulation) as mediators of 5-month follow-up clinical outcomes; (3) To preliminarily explore whether specific sociodemographic and clinical characteristics can predict the short-and medium-term clinical response to the specific treatments. Participants will be 120 children (7 to 12 years) with ADHD recruited at Child and Adolescent Mental Health Service (CAMHS) Sant Joan de Déu Terres de Lleida (Spain) randomly allocated to one of the four study arms: TAU vs. TAU + CT vs. TAU + M4H vs. TAU + MCT. An assessment to collect ADHD symptoms, Executive Functions (EF), comorbid symptoms and global functioning will be conducted pre-intervention, post-intervention (2 months after baseline) and at the 5-month follow-up. Linear mixed models and mediational models will be computed. If the preliminary effectiveness and feasibility of the MCT are demonstrated, this study could be a preliminary basis to do a full RCT with a larger sample to definitively validate the intervention. The MCT could be applied in clinical practice if it is definitively validated.Clinical trial registration:ClinicalTrials.gov, identifier, NCT05937347. https://clinicaltrials.gov/study/NCT05937347?locStr=Spain&country=Spain&cond=ADHD&intr=Mindfulness&rank=1.

The ESCAPE Trial for Older People With Chronic Low Back Pain: A Feasibility Study of a Clinical Trial of Group-Based Exercise in Primary Health Care.

Low back pain is a highly disabling health condition that generates high costs for patients and healthcare systems. For this reason, it is considered a serious public health problem worldwide. This pilot study aimed to assess the feasibility of a future randomized controlled trial (RCT) by evaluating adherence to treatment, contamination between groups, satisfaction with treatment, and understanding of the exercise instructions provided by the physiotherapist. Additionally, we sought to identify and implement necessary modifications to the exercise protocol for better suitability in older people. We conducted a prospective, registered pilot RCT comparing an 8-week group-based exercise program with a waiting list in older people (≥60years old) with chronic low back pain. Sixty participants were recruited through social media, pamphlets, and invitations at community referral centers. The study demonstrated the feasibility of a full RCT. Participants reported high satisfaction with the treatment (i.e.,100% indicated willingness to return for future services) and a high understanding of the exercise instructions (i.e.,81.8% reported "very easy" comprehension). Adherence to the exercise program exceeded the average reported for group exercise interventions in older adults (i.e.,82.58%). Dropout was associated solely with preexisting physical activity levels. The exercise protocol was successfully adapted to better suit the needs of the older adult population. This pilot RCT demonstrates the feasibility of a full-scale RCT to evaluate the effectiveness of group exercise in improving pain intensity and disability in older adults with chronic low back pain. The implemented adjustments to the exercise protocol and overall study approach strengthen the methodological foundation and expected accuracy of the future RCT.

Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial

BackgroundAcquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem and fatigue. These changes can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it is feasible that supporting sexual wellbeing will benefit psychological wellbeing. However, neurorehabilitation is inconsistent and often fragmented across the UK, and psychological, sexual and social support are lacking. Research shows that self-management and peer-support programmes can improve quality of life, self-efficacy and psychological wellbeing after brain injury. This protocol describes a feasibility randomised controlled trial (RCT) of a digital self-management programme to support mental and sexual wellbeing (known as HOPE4ABI), co-designed with and for people with ABI.MethodsThis mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria include age > 18 years, diagnosed or suspected ABI > 3 months prior to trial entry, access to an Internet-enabled device and ability to engage with the intervention. Referrals to the study website will be made via the National Health Service (NHS), social media and partnering organisations. Sixty eligible participants will be randomised at a ratio of 1:1 to peer-supported (n = 30) or self-directed (n = 30) HOPE4ABI programmes. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence and usage. Secondary outcomes related to standardised measures of quality of life, sexual wellbeing and mental wellbeing. Participants and peer facilitators will be interviewed after the course to assess acceptability across both trial arms.DiscussionThis feasibility trial data is not sufficiently powered for inferential statistical analyses but will provide evidence of the feasibility of a full RCT. Quantitative trial data will be analysed descriptively, and participant screening data representing age, ethnicity and gender will be presented as proportions at the group level. These data may indicate trends in reach to particular demographic groups that can inform future recruitment strategies to widen participation. Progression to a definitive trial will be justified if predetermined criteria are met, relating to recruitment, retention, engagement and acceptability.Trial registrationISRCTN46988394 registered on March 1, 2023.

A Parent–child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol

IntroductionPreschoolers and school-aged children with congenital heart disease (CHD) are at higher risk of attention deficit hyperactivity disorder (ADHD) compared with the general population. To this day, no randomised controlled...

Computer-based cognitive training for cognitive development of alcohol-exposed children in South Africa: a feasibility randomised control trial

Children exposed to alcohol in utero may suffer from cognitive and physical sequelae. The most impactful damage in terms of daily functioning is to higher order cognitive functions involved in planning and goal-directed behaviour, referred to as executive functions. Cognitive training interventions are used as a remedial tool for executive function deficits but require implementation by professionals. For the South African context, where resources are limited, a tablet computer-based cognitive training game was developed. This study aimed to establish the feasibility of implementing and evaluating this intervention in South Africa for children exposed to alcohol prenatally. This was a three-arm feasibility randomised control trial comparing an alcohol exposed intervention arm, to an alcohol exposed control arm, and a non-exposed normative arm. Arm allocation was based on self-reported maternal alcohol use during a structured interview. To assess feasibility, we evaluated participant recruitment and barriers to implementation. Executive functions were measured at baseline and following intervention to evaluate the preliminary impact of the intervention. No significant differences were found between the three arms on the post-intervention assessments. The retention rate was acceptable for a randomised control trial; however, there was significant variance in the length of time spent playing the game overall. The majority of participants learned to play the game quickly and progressed through the difficulty levels. In conclusion, a full randomised control trial using the recruitment, randomisation and implementation method would be suitable in the South African context. The statistical outcomes of this trial do not support a full-scale randomised control trial of this intervention.

THE HIPHOP STUDY: A FEASIBILITY STUDY FOR A RANDOMIZED CONTROLLED TRIAL OF HYBRID VERSUS CEMENTED TOTAL HIP ARTHROPLASTY

Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021).Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings.The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training.We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.

Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients

IntroductionIn-bed leg cycling with critically ill patients is a promising intervention aimed at minimising immobility, thus improving physical function following intensive care unit (ICU) discharge. We previously completed a pilot...

Evaluating an emotion coaching programme for parents of young adolescents attending Child Adolescent Mental Health Services (CAMHS) in New Zealand: protocol for a multi-site feasibility trial including co-design with service users

BackgroundEarly adolescence is a time of increased vulnerability for the development of common mental health conditions such as anxiety and depression (internalising outcomes). Current treatments such as cognitive-behavioural therapy and antidepressant medication are focused on the individual and have small effect sizes, particularly in real-world clinical settings such as the public Child Adolescent Mental Health Services (CAMHS). Parents are an important and under-utilised resource in treating these conditions in young adolescents. Teaching parents how to respond to their young person’s emotions can improve emotion regulation and reduce internalising outcomes. One emotion-focused programme for parents of this age group is Tuning in to Teens (TINT). This is a structured, manualised skills group for parents only focused on teaching skills to coach young people through their emotional experiences. This study aims to investigate the impact of TINT in the clinical setting of publicly funded CAMHS in New Zealand.MethodsThe trial will evaluate the feasibility of a two-arm multi-site randomised control trial (RCT). Participants will be 10–14-year-olds referred to CAMHS in Wellington, New Zealand, with anxiety or depression, and their parents or guardians. Arm 1 will be parents attending and implementing TINT (in addition to the usual care received at CAMHS). Arm 2 will be usual care only. TINT groups will be facilitated by CAMHS clinicians who have been trained in the programme and will be delivered over 8 weekly sessions. Prior to the RCT, a co-design methodology will be used with service users to inform outcome measures used in the trial. A group of service users meeting the RCT criteria will be recruited to take part in workshops to help determine their priority outcomes. Measures based on the results of workshops will be included in the outcome measures. The primary feasibility outcomes will be the recruitment and retention of participants, acceptability of the intervention for service users and clinicians and acceptability of outcome measures.DiscussionThere is a need to improve outcomes for the treatment of adolescent anxiety and depression. TINT is a programme with the potential to enhance outcomes for those accessing mental health services by providing targeted support to parents of adolescents. This trial will inform whether a full RCT is feasible to evaluate TINT. Including service users in the design will increase its relevance of an evaluation in this setting.Trial registrationThe Australian New Zealand Clinical Trials Registry (ACTRN): ACTRN12622000483752. Registered on 28 March 2022.

Effects of a culturally tailored, family-support, community-based self-management education and support programme on clinical outcomes amongst adults with type 2 diabetes in Western Ethiopia: A pilot randomised controlled trial.

To examine the preliminary effects of a culturally tailored, family-supported, community-based diabetes self-management education and support (DSMES) programme for Ethiopian people with type 2 diabetes on glycosylated haemoglobulin (HbA1c), blood pressure, body mass index and lipid profiles. A two-arm pilot randomised controlled trial (RCT) was conducted involving 76 patient-caregiver dyads from Western Ethiopia, which were randomly allocated to the intervention arm to receive 12 hours of DSMES intervention guided by social cognitive theory on top of usual care, or to the control group, which received usual care. Whilst HbA1c was a primary outcome, the blood pressure, body mass index and lipid profiles were secondary outcomes. Primary outcome was the change in HbA1c between baseline and 2-month follow-up between the groups. Generalised estimating equations was used to test the preliminary effect of the DSMES programme on the outcomes at baseline, post-intervention and at 2-month follow-up for secondary outcomes. Cohen's d was used to estimate the between-group effect sizes of the intervention. The DSMES produced significant improvement in HbA1c with large effect size (β = -1.667, p < 0.001, d = -0.81) and triglycerides with medium effect size (d = -0.50). HbA1c in the intervention group was decreased by 12 mmol/mol (1.1%). Although non-significant, the DSMES also had small to moderate effects (d = -0.123 to 0.34) on blood pressure, body mass index, total cholesterol, low-density and high-density lipoproteins when compared with usual care. A culturally tailored, social-cognitive theory guided, family-supported, community based DSME programme could have a benefit on HbA1c and triglycerides. A full RCT is warranted to test the effectiveness of the DSMES programme.

Effect of Godelieve Denys-Struyf (GDS) muscle and articulation chain treatment on clinical variables of patients with chronic low back pain and lumbar disc degeneration: a pilot feasibility randomized controlled trial

BackgroundPatients with chronic low back pain (LBP) and lumbar disc degeneration are recommended to try out nonsurgical treatment options before surgery. There is need for good nonsurgical alternatives that can be adapted to the patient’s needs and level of function. The aim of this pilot trial was to test study feasibility of a future full randomized controlled trial (RCT) evaluating the feasibility and benefit of the physiotherapy-based Godelieve Denys-Struyf (GDS) muscle and articulation chain treatment for patients with chronic LBP and lumbar disc degeneration referred to surgical assessment in a hospital outpatient clinic.MethodsThis study is a single-center, two-arm, single-blinded, pilot RCT conducted in a regional hospital in Norway. Patients of age 35–75 years with chronic (> 3 months) LBP and degenerative lumbar disc(s) verified by imaging were included. They filled in a baseline questionnaire prior to randomization, including the Oswestry Disability Index (ODI), numerical rating scale for pain in back and pain in leg, and the EuroQoL 5L. Patients in the control group were free to use treatment as usual. Patients in the intervention group received 8 sessions over a period of 10 to 14 weeks of GDS muscle and articulation chain treatment.ResultsThe recruitment rate was slow, approximately 3/4th of the referred patients met the inclusion criteria, but majority of eligible participants (94%) were willing to participate. A total of 30 patients were randomized into the two groups. The randomization led to skewed distribution of radiating leg pain in the two groups. All participants except one (97%) completed 4 months follow-up. No serious adverse events attributable to the trial treatments were reported. The Oswestry Disability Index (ODI) and leg pain intensity scale were both suitable as primary outcomes in a full trial. The mean change in the ODI score was 8.7 (SD 16.1) points in the GDS arm, whereas there was a minor deterioration in the ODI scores of −3.7 (7.5) points in the control arm. A sample size calculation based on the ODI scores resulted in a number needed to treat of 3.ConclusionsA future full RCT is feasible and would provide evidence about the effectiveness of a GDS treatment for patients with chronic LBP and lumbar disc degeneration.Trial registrationClinicalTrials.gov ID: 910193.

Group antenatal care: findings from a pilot randomised controlled trial of REACH Pregnancy Circles

BackgroundAntenatal care has the potential to impact positively on maternal and child outcomes, but traditional models of care in the UK have been shown to have limitations and particularly for those from deprived populations. Group antenatal care is an alternative model to traditional individual care. It combines conventional aspects of antenatal assessment with group discussion and support. Delivery of group antenatal care has been shown to be successful in various countries; there is now a need for a formal trial in the UK.MethodAn individual randomised controlled trial (RCT) of a model of group care (Pregnancy Circles) delivered in NHS settings serving populations with high levels of deprivation and diversity was conducted in an inner London NHS trust. This was an external pilot study for a potential fully powered RCT with integral economic evaluation. The pilot aimed to explore the feasibility of methods for the full trial. Inclusion criteria included pregnant with a due date in a certain range, 16 + years and living within specified geographic areas. Data were analysed for completeness and usability in a full trial; no hypothesis testing for between-group differences in outcome measures was undertaken. Pre-specified progression criteria corresponding to five feasibility measures were set. Additional aims were to assess the utility of our proposed outcome measures and different data collection routes. A process evaluation utilising interviews and observations was conducted.ResultsSeventy-four participants were randomised, two more than the a priori target. Three Pregnancy Circles of eight sessions each were run. Interviews were undertaken with ten pregnant participants, seven midwives and four other stakeholders; two observations of intervention sessions were conducted. Progression criteria were met at sufficient levels for all five measures: available recruitment numbers, recruitment rate, intervention uptake and retention and questionnaire completion rates. Outcome measure assessments showed feasibility and sufficient completion rates; the development of an economic evaluation composite measure of a ‘positive healthy birth’ was initiated.ConclusionOur pilot findings indicate that a full RCT would be feasible to conduct with a few adjustments related to recruitment processes, language support, accessibility of intervention premises and outcome assessment.Trial registrationISRCTN ISRCTN66925258. Retrospectively registered, 03 April 2017.

Rehabilitation Outcomes Following Hip Fracture of Home-Based Exercise Interventions Using a Wearable Device-A Randomized Controlled Pilot and Feasibility Study.

Although hip fractures are common and severe, there is insufficient evidence concerning which type of rehabilitation is most beneficial. The primary aim of this three-armed pilot study was to investigate any difference in outcome after hip fractures between and within groups in terms of balance, everyday activities, and health-related quality of life (HRQoL) following different home rehabilitation interventions. Further aims were to study feasibility and to suggest, if necessary, adjustments to the protocol for a future full randomized controlled trial (RCT). In total, 32 persons were included in this study. The intervention groups underwent the HIFE program with or without an inertial measurement unit, while the control group underwent standard rehabilitation. Within- and between-groups differences in outcomes and feasibility outcomes in terms of recruitment and retention rates were analyzed, and the ability to collect primary and secondary outcomes was assessed. Balance, measured as postural sway, showed no significant improvement in any group. All three groups improved in functional balance (p = 0.011-0.028), activity of daily living (p = 0.012-0.027), and in HRQoL (p = 0.017-0.028). There were no other significant changes within or between the groups. The recruitment rate was 46%, the retention rate was 75%, and the ability to collect outcome measures was 80% at baseline and 64% at follow-up. Based on the results, it is possible to, after adjusting the protocol, conduct a full RCT.

‘Self-Management Intervention through Lifestyle Education for Kidney health’ (the SMILE-K study): protocol for a single-blind longitudinal randomised controlled trial with nested pilot study

IntroductionMany people living with chronic kidney disease (CKD) are expected to self-manage their condition. Patient activation is the term given to describe the knowledge, skills and confidence a person has...

A Pragmatic Pilot Randomized Controlled Trial of the OA Go Away Among Individuals with Osteoarthritis of the Hip or Knee.

Purpose: The main objective was to assess the feasibility of conducting a full randomized controlled trial (RCT) to test the effectiveness of the OA Go Away (OGA) behavioural intervention on adherence to prescribed exercise, level of physical activity, goal attainment, and health outcomes, and to determine the acceptability of the OGA. The OGA is an internal reinforcement tool designed to promote exercise adherence for people with hip or knee OA. Method: This 3-month pragmatic pilot RCT included 40 participants with hip or knee OA who were randomized into the treatment group who used the OGA for three months, or standard care. Results: This pilot RCT which included 37 participants (17 in the treatment group and 20 in the control group) showed that it would be feasible to complete a full RCT of the OGA behavioural intervention with adjustments to the format of the OGA (electronic), inclusion criteria, outcome measures and duration. The OGA was felt to be useful (75%) and motivational (82%) by participants. Conclusions: This pilot RCT justifies a formal RCT of the OGA and shows promising results concerning its acceptability, especially if available in an electronic format.

Randomised controlled trials of occupational therapy interventions for adults with a mental health condition or dementia: A systematic review of study methods and outcome measurement

Introduction High-quality randomised controlled trials (RCTs) of interventions are essential for determining whether an intervention is effective. However, many RCTs that examine the effectiveness of occupational therapy interventions for adults with mental health conditions or dementia have methodological limitations that reduce confidence in their results. We aimed to systematically review the quality of methods and outcome measures used in RCTs of occupational therapy interventions for adults with a mental health condition or dementia. This will inform future research in this area and enable practitioners to appraise the evidence when selecting interventions. Method We searched peer-reviewed English language publications from 2000 to 2021 in MEDLINE, PsycINFO, ASSIA, CINAHL and e-thos, and hand-searched 12 journals. We included papers that met pre-specified inclusion criteria, appraised quality using a validated tool and extracted data. We conducted a narrative synthesis. Results Of thirty-three included papers, 26 reported full or pilot RCTs, two reported secondary analysis or secondary outcomes of included RCTs, three reported process evaluations and two reported economic evaluations. Methodological limitations were found in many studies and outcome measures varied in their psychometric quality. Conclusion High-quality RCTs of occupational therapy interventions are needed for adults with mental health conditions and dementia. Researchers should follow international guidelines for rigorously developing and evaluating interventions and reporting studies. Practitioners should critically apply RCT evidence when selecting occupational therapy interventions.