Effectiveness of Fewer Falls, an online group-based self-management fall prevention programme for people with multiple sclerosis: protocol of a randomised controlled trial

Introduction
Fewer Falls is a manualised self-management fall prevention programme co-developed for and with ambulatory and non-ambulatory people with multiple sclerosis (PwMS). Findings from a feasibility study indicate the necessity of a full-scale randomised controlled trial (RCT).

Methods and analysis
A parallel-group RCT with a mixed methods process evaluation as well as a cost-effectiveness evaluation will be conducted. We aim to recruit 240 PwMS, who will be stratified by ambulation level and randomised 1:1 in blocks of eight to intervention or control. The group-based self-management fall prevention intervention involves eight 2-hour online synchronous sessions (approximately eight participants/group) facilitated by a licensed healthcare professional and home assignments to be completed by participants between sessions. The setting is online, and participants can be located anywhere in Sweden. The control and intervention groups will also receive a brochure on fall risk factors and fall prevention in addition to their standard MS care and rehabilitation. Data collection will be performed at baseline and 3, 6 and 12 months after the start of the intervention. Falls will be monitored via a short message service every week during 1 year from the start of the intervention. The primary outcome is fall frequency (falls/person/year). Secondary outcomes include injurious falls, falls control, fear of falling, falls self-efficacy, activity curtailment, perceived effect of MS, self-rated health and cost-effectiveness.

Ethics and dissemination
Ethical approval has been obtained from the Swedish Ethical Review Authority (registration numbers 2022-06667-01 and 2023-07723-02). The RCT will adhere to the Declaration of Helsinki. Written consent to participate will be obtained from all participants. Study-related information about participants will be stored securely at Karolinska Institutet. The results will be presented in peer-reviewed journals, through the patient organisation Neuro Sweden, at conferences, and in social media.

Trial registration number
ClinicalTrials.gov, NCT05789225.

Leggi
Gennaio 2025

Exploring the status of online social support for older adults with cancer: a scoping review protocol

Introduction
The estimated number of new cases among older adults with cancer has been increasing. Considering the decrease in social networks as adults age, their need for social support is often unmet. Notably, an increasing number of older adults with cancer have access to social support through online technologies, especially since the COVID-19 pandemic, which heightened the need for online social support. Little is known, however, about the extent to which online social support for older people with cancer has developed. This scoping review aims to explore the developments in online social support for older adults with cancer.

Methods and analysis
We will search PubMed, Elsevier Embase (including Medline) and EBSCO CINAHL Complete to identify eligible studies based on predefined criteria. Screening of articles and data extraction will be carried out independently by two reviewers, with conflicts resolved by a third reviewer. This scoping review will be based on the Arksey and O’Malley methodological framework with the extension proposed by Levac and colleagues. The review findings will be presented in a narrative analysis using tables. This protocol is registered on Open Science Framework at https://doi.org/10.17605/OSF.IO/Z9XJ7.

Ethics and dissemination
No ethical approval is needed. The findings will be published in a peer-reviewed journal and presented at conferences.

Leggi
Dicembre 2024

Transforming Households with Refraction and Innovative Financial Technology (THRIFT): study protocol for a randomised controlled trial of vision interventions and online banking among the elderly in Kurigram

Introduction
Presbyopia, difficulty in seeing close-ups, affects a billion people globally. Mobile financial services (MFS) have been mandated since January 2021 for Bangladesh government social safety net payments, including old age allowance (OAA) and widow allowance (WA). We report the protocol for the Transforming Households with Refraction and Innovative Financial Technology randomised trial assessing the impact on the use of online banking of providing presbyopic safety net beneficiaries with reading glasses, and brief smartphone and mobile banking app training.

Methods and analyses
Eligible participants (n=484) are OAA (men aged 65–70 years; women aged 62–70) or WA recipients (women aged 48–60) with presbyopia as their only vision problem, passing a smartphone-based test of numeracy, cognition and dexterity, and not currently owning a smartphone or independently using MFS. All participants receive smartphones loaded with a mobile banking app and a transaction-tracking app and are randomised 1:1 to receive immediate free near-vision glasses and half-day training for smartphone and banking app use (intervention), or glasses and training 12 months later (control). The primary outcome is the mean quarterly number of mobile bank transactions over the 12-month follow-up period, comparing study groups, with and without adjustment. Secondary outcomes include food security, healthcare access and social connectedness.

Ethics and dissemination
The protocol was approved by ethics committees at Queen’s University Belfast (reference #MHLS22_69) and BRAC James P Grant School of Public Health (reference #IRB-21 August’22-028). The trial is conducted in accordance with the Declaration of Helsinki and national regulations in Bangladesh, and results will be published in open-access, peer-reviewed journals.

Trial registration number
NCT05510687; ClinicalTrials.gov.

Leggi
Dicembre 2024

Readability of online and offline written health information: a protocol of a systematic review of systematic reviews

Introduction
Healthcare organisations should create and disseminate readable information to citizens and patients to reduce the level of health literacy required for individuals. Several systematic reviews have reported overviews of the readability of written health information for each subject area. This systematic review of systematic reviews will synthesise evidence from existing systematic reviews to provide an overview of studies that assessed readability in diverse areas and identify gaps to be filled in future research and practice to improve the readability of health information.

Methods and analysis
The following databases will be searched: PubMed, MEDLINE, CINAHL, PsycINFO, Web of Science Core Collection, Scopus, Cochrane Database of Systematic Reviews, and Google Scholar. The reference lists of the eligible studies will be searched to identify additional studies. The eligible literature will be systematic reviews of published empirical studies that quantitatively assessed the readability of health information for patients and/or citizens. Two independent reviewers will screen the titles, abstracts and full texts of all identified literature. A lead researcher will extract the data, and a second reviewer will check the results. Discrepancies will be resolved through discussion, and a third reviewer will be involved if necessary. Data, such as the characteristics of the systematic review, characteristics of the reviewed literature in the systematic review, subject area, material characteristics, definition(s) of readability, readability assessment methods, main results and quality assessment, will be extracted. The findings will be synthesised in a numerical summary and a descriptive and narrative review.

Ethics and dissemination
This review does not involve any ethical concerns. The results and implications of this systematic review will be disseminated at conferences and in peer-reviewed journals.

Leggi
Dicembre 2024

Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study

Introduction
A diagnosis of melanoma in situ presents negligible risk to a person’s lifespan or physical well-being, but existing terminology makes it difficult for patients to distinguish these from higher risk invasive melanomas. This study aims to explore whether using an alternative label for melanoma in situ may influence patients’ management choices and anxiety levels.

Methods and analysis
This study is a between-subjects randomised online experiment, using hypothetical scenarios. Following consent, eligible participants will be randomised 1:1:1 to three labels: ‘melanoma in situ’ (control), ‘low-risk melanocytic neoplasm’ (intervention 1) and ‘low-risk melanocytic neoplasm, in situ’ (intervention 2). The required sample size is 1668 people. The co-primary outcomes are (1) choice between no further surgery or further surgery to ensure clear histological margins greater than 5 mm and (2) choice between patient-initiated clinical follow-up when needed (patient-led surveillance) and regular routinely scheduled clinical follow-up (clinician-led surveillance). Secondary outcomes include diagnosis anxiety, perceived risk of invasive melanoma and of dying from melanoma and management choice anxiety (after surgery choice and follow-up choice). We will make pairwise comparisons across the three diagnostic label groups using regression models (univariable and multivariable).

Ethics and dissemination
The study has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000740594). Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2024/HE000019). The results of the study will be published in a peer-reviewed medical journal, and a plain language summary of the findings will be shared on the Wiser Healthcare publication page (https://www.wiserhealthcare.org.au/category/publications/).

Trial registration number
Australian New Zealand Clinical Trials Registry (ID 386943).

Leggi
Dicembre 2024