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Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer surv

Por: De Groef · A. · Dams · L. · Moseley · G. L. · Heathcote · L. C. · Wiles · L. K. · Catley · M. · Vogelzang · A. · Hibbert · P. · Morlion · B. · Van Overbeke · M. · Tack · E. · Van Dijck · S. · Devoogdt · N. · Gursen · C. · De Paepe · A. L. · Mertens · M. · van Olmen · J. · Willem · L. · Tja
Introduction

Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).

Methods and analysis

A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.

Trial registration number

ClinicalTrials.gov Identifier: NCT06308029.

Bridging the digital divide for people with aphasia: a study protocol for codesigning web accessibility tools and guidelines

Por: Lee · J. · Worthy · P. · Deslandes · R. · Burton · B. · Copland · D. A. · Jamieson · P. · Barron · K. · Togher · L. · Shrubsole · K. · Shiggins · C. · Campbell · J. · Hill · A. · Wiles · J. · Haslam · S. A. · Wallace · S. J.
Introduction

Aphasia is a language impairment that affects one-third of people who experience a stroke. Aphasia can impact all facets of language: speaking, understanding, reading and writing. Around 60% of people with aphasia have persistent language impairments 1 year after their stroke, requiring ongoing healthcare and support. In recent years, the internet has become a key resource for the self-management of chronic health conditions. Navigating web content, however, requires language use, and as such, people living with aphasia are more likely to be excluded from digital health and support services. Web Content Accessibility Guidelines exist; however, they do not fully address the unique and diverse needs of people with aphasia, and a significant proportion of websites (over 90%) do not fully adhere to them. This protocol paper describes the first two stages of the Bridging the Digital Divide project, which aims to codesign and develop (a) a web-browser extension to re-render webpages to an ‘aphasia-friendly’ (accessible) format, (b) training tools to help users and health professionals customise the web-browser extension and (c) guidelines for developing communication-accessible websites.

Methods and analysis

The research will be conducted using experience-based codesign. In Stage 1a, focus groups will be held with (1) people with aphasia, (2) family members or significant others and (3) health professionals working with people with aphasia. Participants will be asked to share their experiences of accessing (or supporting a person with aphasia to access) healthcare, information and support services on the web. The nominal group technique (NGT) will be used to identify priorities for improving web accessibility for people with aphasia. Focus group data will be analysed using reflexive thematic analysis, and prioritisation data will be analysed using inductive qualitative content analysis. In Stage 1b, eight codesign workshops will be held with representatives of the three key stakeholder groups to iteratively codesign and develop a web-browser extension, training tools and guidelines to support web accessibility.

Ethics and dissemination

Ethical clearance for Stage 1a and Stage 1b of this project has been approved by the University of Queensland Human Research Ethics Committee (Stage 1a approval number: 2023/HE000528, Stage 1b approval number: 2024/HE000721). The outcomes of this research will be disseminated in peer-reviewed journals and presented at national and international conferences. A dissemination and celebration event will be held at the completion of the project.

Primary care practitioners and patients views on the benefits and challenges of remote consulting for anxiety and depression in UK general practice: a qualitative interview study

Por: Archer · C. · Ting · L. · Kessler · D. · Wiles · N. · Turner · K. M.
Objective

To explore primary care patients’ and practitioners’ views and experiences of remote consulting for common mental disorders (CMDs), to optimise their management in primary care.

Design

Qualitative study using in-depth interviews and thematic analysis. A topic guide was used to ensure consistency across interviews. The interviews were audio-recorded, transcribed verbatim and analysed thematically. There was patient and public input throughout.

Setting

Participants were recruited from general practices. Interviews were held by telephone or videocall between March 2023 and October 2023.

Participants

We interviewed 20 practitioners and 21 patients.

Results

Interviewees suggested benefits included convenience, increased anonymity and were easier for those feeling very low or anxious. Challenges included practitioners finding it hard to assess risk, which lengthened consultation duration or led to further contact, increasing practice workload and patients feeling anxious waiting for the practitioner to call. In-person appointments were viewed as important for initial consultations and providing a safe space. Continuity of care and practitioner training were identified as facilitators for telephone consultations, and both patients and practitioners identified training needs around how to deliver mental healthcare remotely.

Conclusions

Practitioners should aim to offer continuity of care and in-person appointments when patients initially seek help. Remote consultations may not be more time or cost-efficient for individuals with CMDs as risk is harder to assess. There is a need to evaluate existing training on delivering remote consultations to identify whether remote mental healthcare is included or should be incorporated in the future.

Feasibility randomised controlled trial to assess the delivery of a novel isometric exercise intervention for people diagnosed with uncomplicated stage 1 hypertension in the National Health Service: key quantitative findings

Por: Wiles · J. D. · Santer · E. · Rees-Roberts · M. · Borthwick · R. · Doulton · T. · Swift · P. A. · Pellatt-Higgins · T. · Saxby · K. · Mills · A. · Gousia · K. · MacInnes · D. · ODriscoll · J. · West · A. · Darby · J. · Short · V. · Farmer · C. K.
Objectives

The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?

Design

Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.

Setting

Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.

Participants

People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)

Intervention participants were randomised (1:1) to either standard lifestyle advice or an individualised isometric wall squat prescription, performed 4x2-min bouts three times a week for 6 months.

Primary and secondary outcome measures

We assessed deliverability, attrition, adherence and variance in blood pressure (BP) change.

Results

IE was found to be easily deliverable to all participants. At 6 months, 34% had withdrawn. Of those who completed IE, 85% of their sessions were at the correct intensity, meeting our retention criterion for success. Variance in BP change was 14.4 mm Hg. The study was not powered to show a difference in BP between groups; however, BP reductions were seen in the intervention group at all study time points compared with baseline. There were no adverse events related to study participation.

Conclusions

We met our a priori recruitment criteria which allowed us to calculate a sample size (n=542) for a full RCT. The results demonstrate good acceptability and adherence rates to the treatment protocol. Our results show a signal towards a consistent sBP reduction in the IE group compared with baseline.

Trial registration number

NCT04936022 (https://classic.clinicaltrials.gov/ct2/show/NCT04936022?cond=isometric+exercise&draw=2&rank=7); registry identifier: ISRCTN 13472393.

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