Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package–DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.

This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention’s outcomes.

This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

NCT06335420.

Graves’ disease (GD) is the most common form of hyperthyroidism in Sweden with an incidence of 21/100 000 individuals, the majority of whom are women of working age. GD can be overwhelming for the affected patient. A way to improve health outcomes is to better understand patients’ experiences of their illness. We therefore aimed to explore patients’ experiences of GD during the initial phase of the disease.

A qualitative study based on semistructured interviews was conducted and analysed using qualitative content analysis, following Graneheim and Lundman’s description of the method.

The study was carried out within specialised care at the secondary level in a Swedish healthcare context.

15 patients (12 women and 3 men; aged 29–74 years) within the first 3 months after GD diagnosis were included in the study.

Being affected by GD means facing a range of new and often incomprehensible symptoms contributing to an experience of change in one’s personality. In contact with healthcare, they experienced challenges such as an overwhelming amount of information, a lack of energy, and feelings of being a burden. These factors were described as having a negative impact on daily life, well-being, and psychological and psychosocial functioning. The participants highlighted the need to be listened to, to receive tailored information, to have continuous contact, and to have fatigue and other symptoms more thoroughly addressed.

The findings indicate that symptoms have a significant impact on patients with GD, influencing their care experience, information processing, decision-making abilities, and daily functioning. The application of person-centred care can be one way to support patients with GD, as it facilitates a collaborative approach and enhances the comprehension of each patient’s needs and resources. By acknowledging the patient’s experiences, situation, and expectations, as well as the comprehensive impact of the disease, and by modifying support strategies, patient well-being and health outcomes may be significantly improved.

To establish, through patient and public involvement (PPI) events, the exercise barriers, facilitators and preferences of people with heart failure with preserved ejection fraction (HFpEF).

Qualitative ‘best fit’ framework analysis was used to analyse field notes and transcripts collected during three patient and public involvement meetings and three workshops. The best fit framework was based on the COM-B model of behaviour change, which has identified that Capability, Opportunity and Motivation components are essential for Behaviour change. The Consolidated criteria for Reporting Qualitative research checklist was used to structure the report.

Setting and participants: Community dwelling older adults with HFpEF.

24 people with HFpEF (n=16 female, 66%), 2 spouses and 2 people with chronic conditions participated in the PPI meetings and workshops. Multiple exercise-related capability (negative symptoms, functional ability, resilience and self-efficacy and knowledge and skill); opportunity (appealing components, optimal conditions, adequate support); and motivation factors (well-being, physical gains, goal achievement, sense of enjoyment) were identified as essential to facilitating change in exercise behaviours in people with HFpEF.

This study provides insight into capability, opportunity and motivation conditions that people with HFpEF feel are necessary to enable them to engage in exercise-related behaviour change. This work extends previous post hoc work by moving beyond identification of broad influencers that may enable or impede exercise intervention engagement, to identify intervention conditions necessary to affect change.

Persistent pain is common among older people living with frailty and can impact on their daily living, mobility, social interactions and sleep. However, healthcare support to mitigate impact is lacking in this population. The Pain in Older People with Frailty (POPPY) study is a multiphase, mixed-methods study that addresses how pain management services for older people with frailty should be organised and delivered.

For this phase (POPPY-Q), we used qualitative methods: semi-structured interviews with a grounded theory approach to analysis.

Community-dwelling older people (≥75 years) with persistent pain and frailty were invited to participate in two qualitative interviews (in-person/remotely) 10 weeks apart. Interviews took place in varied geographical locations across England between July 2022 and August 2023 and explored experiences of living with pain and access to and engagement with services and healthcare professionals (HCPs) and support and treatments received for pain.

Twenty-six people (77–91 years) with pain and frailty (from mild to severe) consented and were interviewed; 24 completed a second interview. Three interviews included a spouse/family member. Themes were general health and well-being; pain and its impact; acceptance of living with pain; support-seeking decisions; experience of accessing support; and perception/experience of pain support and treatment. This paper focuses on pain acceptance and support-seeking; other themes are used contextually, and accessing support was rare. Many participants were stoical about pain; some prioritised other health conditions; some preferred self-management; some were resigned and had lost hope of effective treatment; some expressed concern about burdening healthcare resources.

HCPs should be aware of the stances of older people with frailty about seeking support for pain and should be proactive, asking about pain. Longer appointments for complex cases may allow general practitioners to address pain, offer reassurance, provide information or referral or arrange a follow-up consultation focused on pain management.

The aim of the study was to evaluate the healthcare costs and effects of a remote person-centred care (PCC) add-on intervention compared with usual care for people with chronic heart failure (CHF) and/or chronic obstructive pulmonary Disease (COPD) from a societal perspective.

A cost-effectiveness analysis (CEA) based on the results from a randomised controlled trial.

The study was conducted from August 2017 until June 2021 within nine primary care centres across Western Sweden.

Participants in the study had a diagnosis of COPD (J43.0, J44.0–J44.9) and/or CHF (I50.0–I50.9).

224 patients were randomly allocated to the study groups. After two withdrawals, the final intention-to-treat analysis included 110 participants in the intervention group and 112 in the control group.

Both the intervention and control group received usual care through their primary care centres. In addition, the intervention group participated in a remote PCC add-on intervention consisting of a digital platform and structured telephone support.

Incremental cost-effectiveness ratio using direct healthcare costs, productivity loss and prescription drug costs, compared with health effects measured using the EuroQoL questionnaire (EQ-5D-3L) over a 2-year time horizon.

The intervention group had lower healthcare utilisation in inpatient care, specialised outpatient care and reduced productivity loss. The CEA showed incremental effects of 0.0469 quality-adjusted life years and incremental costs of SEK –68 533 (Swedish crowns). The PCC alternative was both more effective and resulted in lower healthcare costs compared with usual care, that is, PCC was dominant.

The results of this CEA demonstrated that a remote PCC add-on intervention for people with COPD and/or CHF had lower healthcare costs and higher health-related quality of life compared with usual care.

NCT03183817 ClinicalTrials.gov.

To describe the usage patterns of patients and healthcare professionals (HCPs) using a person-centred telehealth and e-health intervention.

An exploratory, descriptive, observational study embedded in the "Person-centred care at a distance (PROTECT)" randomised controlled trial (ClinicalTrials.gov: NCT03183817) as part of a process evaluation. Data on intervention use and time spent on the intervention were collected. Descriptive statistics were calculated.

Participants were recruited from nine public primary healthcare facilities located in various areas of Gothenburg, Sweden.

110 patients participating in the intervention group in the PROTECT trial were included. Participants were diagnosed with chronic heart failure (CHF, n=42), chronic obstructive pulmonary disease (COPD, n=56) or both (n=12). They were 33–93 years old (mean 71 years).

A secondary outcome report on resource use.

The 6-month-long intervention was performed as an add-on to standard care and comprised person-centred telephone support and access to a digital platform. Per-protocol use included co-creation of a health plan via the telephone and use of the digital platform at least once. Forms of use were tailored to the preferences and needs of the patients.

Most intervention activities took place in the first 3 months of the intervention. Most patients used a combination of phone and digital support, spending most of their time using the digital platform. Overall, patients and HCPs spent 6 and 2.5 hours/patient using the intervention, respectively. Of this time, 1.5 hours involved synchronous communication through phone calls, with health-plan calls averaging 77 min.

The intervention usage patterns of patients and HCPs differed. Despite HCPs being accessible when required, patients dedicated most of their time to self-care practices. Based on time distribution data, 15 full-time HCPs could potentially co-create, document and follow-up on health plans for 10 000 patients under study conditions.

ClinicalTrials.gov: NCT03183817.

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

NCT04897516.

Digital inclusion (which includes skills, accessibility and connectivity to the internet and digital devices) is a ‘super social determinant of health’ because it affects many aspects of life that influence health. Older people are especially vulnerable to digital exclusion. Existing digital inclusion interventions are commonly offered opportunistically to people who come into contact with services, or in specific locations. The lack of systematic identification of need unintentionally excludes older people who may be most in need of support, and that support is not addressing their needs.

This multi-method project includes six workstreams: (1) A survey of people aged 65+ to ask about digital use and engagement. Survey data will be used to develop a model that predicts digital exclusion from data available in primary care records. (2) Testing, via a further survey, the external validity of the model to identify those who are digitally excluded. (3) Interviews with community service providers to identify, understand and define the components of existing digital inclusion services for older people. Concurrently, a rapid review of the literature will identify evidence for interventions aimed at supporting digitally excluded adults aged 65+. (4) Interviews with people aged 65+ representing a range of digital use will explore factors from the COM-B model that influence digital behaviours—their capability (C), opportunity (O) and motivation (M) relating to digital engagement. Analysis outputs will identify the intersectional nature of barriers or facilitators to digital inclusion. (5) Co-production workshops with older people and community service providers will identify key components of interventions that are required to address digital exclusion. Components will be mapped against existing interventions, and the ‘best fit’ intervention(s) refined. An implementation plan will be developed in parallel. (6) Feasibility testing of the refined intervention(s) to assess acceptability and obtain feedback on content and delivery mechanisms.

This study was approved by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee on 23 October 2023 (ref. 23/YH/0234). Findings will be disseminated in academic journals and shared at webinars, seminars, conferences and events arranged by organisations operating across the digital inclusion and older people fields.

https://www.isrctn.com/ISRCTN18306736

Treatment of the two billion people with tuberculosis (TB) infection worldwide is crucial to prevent progression to TB disease and thereby prevent further transmission. However, TB is associated with fear and stigma, and knowledge gaps about TB disease are widespread, complicating adherence to treatment. As increasing knowledge about TB can reduce stigma and increase adherence to treatment, we developed an educational film about TB infection and disease. After showing the film to people with TB, our qualitative study aimed to evaluate the film and to explore perceptions, fears and possible knowledge gaps.

We conducted a qualitative study, with in-depth interviews (n=13), at two Infectious Disease Outpatient Departments in Sweden. Included research participants were adults with TB infection or TB disease. After informed consent, the participants watched the film, available in Swedish, English, Somali and Tigrinya. Subsequently, in-depth interviews, using a topic guide, were conducted, transcribed, and a reflexive thematic analysis was performed.

All participants considered the film to be a valuable addition to the written and oral information they had previously received. Identified themes included the perception of TB infection being a deadly, non-curable disease, and many feared being contagious. However, the film challenged these fears and increased the understanding of TB infection being treatable and non-infectious. Another theme revealed that TB-related stigma was experienced in encounters with healthcare professionals in Sweden.

Our educational film was perceived to increase understanding about TB symptoms, transmission and treatment. Implementing the film in Infectious Disease Departments across Sweden may contribute to decreasing stigma and enhancing awareness of the importance of treatment adherence, an outcome that warrants further investigation post-implementation.