Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project.

BACKGROUND: The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life. METHODS: This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called "Friends in Nature" or to the control group. "Friends in Nature" uses modifications of the "Circle of Friends" methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed. DISCUSSION: The three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections. TRIAL REGISTRATION: Barcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022. Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022. Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022.

Dropout and compliance to physical exercise in menopausal osteopenic women: the European "happy bones" project.

Introduction: Decline in muscle mass and bone density seem to be two of the most disabling side effects of menopause that negatively affect women's quality of life. Promoting physical activity protocols in the workplace can represent a focal point in the prevention and management of several diseases. The study aims to evaluate the compliance and drop-out of menopausal osteopenic women engaged in combined training performed inside and outside the workplace. Strength and balance were analyzed to evaluate the effect of this protocol on osteoporosis prevention and the risk of falling. Methods: 73 menopausal women were enrolled in 5 European countries. They performed 72 lessons of a combined training proposed in the working place (IW) or sport center (SC). Results: Out of the total 39 women enrolled in the IW, 12.8% had to leave the program, while out of the 34 women enrolled in SC, 41.2% did not complete the training. According to the compliance results, 47% of women that completed the trained IW and 85% in the SC recorded high compliance (p = 0.019). Moreover, the strength of the lower limbs (p < 0.001) and static balance (p = 0.001) significantly improved in the whole group. Discussion: In conclusion, proposing well-structured training in the workplace for menopausal women seems to reduce drop-out. Strength and balance results suggest its positive impact on bone health and risk of falls, despite where it is performed.

Identification of decreased intrinsic capacity: Performance of diagnostic measures of the ICOPE Screening tool in community dwelling older people in the VIMCI study.

BACKGROUND: The World Health Organization (WHO) has developed the Integrated Care for Older People (ICOPE) strategy to face the challenges of ageing societies. This strategy is focused on person centered care and the assessment intrinsic capacity (IC). Early identification of five domains of IC (cognition, locomotion, vitality, sensory (hearing and vision), and psychological) has been shown to be related with adverse outcomes and can guide actions towards primary prevention and healthy ageing. IC assessment proposed by the WHO ICOPE guidelines is composed by two steps: First, Screening for decreased IC by the ICOPE Screening tool; second, by the reference standard methods. The aim was to assess the performance of diagnostic measures (sensibility, specificity, diagnostic accuracy, and agreement of the ICOPE Screening tool) compared to the reference standard methods in European community-dwelling older adults. METHODS: Cross-sectional analysis of the baseline of the ongoing VIMCI (Validity of an Instrument to Measure Intrinsic Capacity) cohort study, which was carried out in Primary Care centers and outpatient clinics from 5 rural and urban territories in Catalonia (Spain). Participants were 207community dwelling persons ≥ 70-year-old with Barthel ≥ 90, without dementia or advanced chronic conditions who provided their consent to participate. The 5 IC domains were assessed by the ICOPE Screening tool and the reference methods (SPPB, gait speed, MNA, Snellen chart, audiometry, MMSE, GDS5) during patients' visit. Agreement was assessed with the Gwet AC1 index. RESULTS: ICOPE Screening tool sensitivity was higher for cognition (0.889) and ranged between 0.438 and 0.569 for most domains. Specificity ranged from 0.682 to 0.96, diagnostic accuracy from 0.627 to 0.879, Youden index from 0.12 to 0.619, and Gwet AC1 from 0.275 to 0.842. CONCLUSION: The ICOPE screening tool showed fair performance of diagnostic measures; it was helpful to identify those participants with satisfactory IC and showed a modest ability to identify decreased IC in older people with high degree of autonomy. Since low sensitivities were found, a process of external validation would be recommended to reach better discrimination. Further studies about the ICOPE Screening tool and its performance of diagnostic measures in different populations are urgently required.

Subjective psychological impacts during COVID-19 lockdown on older people, risk profiles and coping strategies: Results of an online survey in Spain.

This study explores the psychological impacts of lockdown among older people during the coronavirus disease 2019 pandemic in Spain, and identifies risk profiles and adaptative behaviors. A cross-sectional online survey was disseminated by social networks through snowball sampling (April-June 2020). The survey included ad-hoc questions about psychological impacts on subjective cognitive functioning, emotional distress, and loneliness. Open end-questions were coded according to Lazarus and Folkman's coping strategies framework. Of the 2010 respondents, 76% experienced impact in at least one cognitive function (11% reporting severe effects), 78% frequent sadness and 13% frequent loneliness. Age 80+, women and low education increased the risk of loneliness and severe impact in memory and processing speed. Living alone was an additional risk factor for loneliness and sadness. Lockdown is associated with cognitive impacts, emotional distress, and loneliness being risk profiles related to inequality axes. Coping strategies should inform aging policies to prevent psychological impacts during the lockdown.

Exploring Vision-Related Quality of Life: A Qualitative Study Comparing Patients' Experience of Cataract Surgery with a Standard Monofocal IOL and an Enhanced Monofocal IOL.

Purpose: To explore quality of life related with intermediate vision of patients before and after cataract surgery, and to make patients' experience available for the design of future scales that assess visual function related with intermediate distance. Patients and Methods: A qualitative research methodology based on thematic content analysis was used to explore vision-related quality of life based on the experiences of patients with cataract. Patients were recruited at the Service of Ophthalmology of the Hospital de Sant Pau (Barcelona, Spain). Data were collected through nineteen semi-structured interviews conducted with patients diagnosed with cataract and implanted with a standard aspheric monofocal intraocular lens (IOL) (Tecnis® ZA9003) (n = 6), an enhanced monofocal IOL (Tecnis® Eyhance ICB000) (n = 6), and patients from the waiting list (n = 7). The data analysis consisted in coding, aggregation, and theme development of the transcribed audios. Results: Patients on waiting lists reported difficulty and insecurity in performing daily and meaningful tasks related to near visual ranges (eg: threading a needle, reading price tags), intermediate (eg: using a computer or dialling numbers on a smartphone), and distant (eg: recognizing faces, walking on uneven surfaces). Patients after surgery with the standard IOL reported improvement in performing activities mainly in the distant visual range, but also the need for a better communication with clinical staff to adjust their own expectations on the results of the surgery. Finally, patients implanted with the enhanced IOL reported satisfaction and improved visual function in performing daily activities, especially those related to the intermediate visual range. Conclusion: Our exploratory study found that patients after cataract surgery with the enhanced IOL reported a better performance in activities that require the intermediate vision. These results will inform the development of scales to assess vision-related quality of life in the intermediate visual range prioritizing outcomes according to patients' daily and meaningful activities.

Reply to Inzitari et al. Comment on "Blancafort Alias et al. A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition, and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Development Study. Int. J. Environ. Res. Public Health 2021, 18, 5979".

This is a reply to the comment by Inzitari et al [...].

A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition, and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Development Study.

The World Health Organization has developed the Integrated Care of Older People (ICOPE) strategy, a program based on the measurement of intrinsic capacity (IC) as "the composite of all physical and mental attributes on which an individual can draw". Multicomponent interventions appear to be the most effective approach to enhance IC and to prevent frailty and disability since adapted physical activity is the preventive intervention that has shown the most evidence in the treatment of frailty and risk of falls. Our paper describes the development of a multi-domain group-based intervention addressed to older people living in the community, aimed at improving and/or maintaining intrinsic capacity by means of promoting physical activity, healthy nutrition, and psychological wellbeing in older people. The process of intervention development is described following the Guidance for reporting intervention development studies in health research (GUIDED). The result of this study is the AMICOPE intervention (Aptitude Multi-domain group-based intervention to improve and/or maintain IC in Older PEople) built upon the ICOPE framework and described following the Template for Intervention Description and Replication (TIDieR) guidelines. The intervention consists of 12 face-to-face sessions held weekly for 2.5 h over three months and facilitated by a pair of health and social care professionals. This study represents the first stage of the UK Medical Research Council framework for developing and evaluating a complex intervention. The next step should be carrying out a feasibility study for the AMICOPE intervention and, at a later stage, assessing the effectiveness in a randomized controlled trial.

Promoting social capital, self-management and health literacy in older adults through a group-based intervention delivered in low-income urban areas: results of the randomized trial AEQUALIS.

BACKGROUND: Evidence is scarce on how to promote health and decrease cumulative inequalities for disadvantaged older people. Downstream complex interventions focusing on intermediate factors (self-management, health literacy and social capital) may have the potential to mitigate the inequitable impacts of social determinants in health. The aim of the AEQUALIS study was to assess the effectiveness of a group-based intervention to improve self-perceived health as indicator of health inequality. METHODS: Pragmatic randomised clinical trial addressed to older adults (≥ 60 years) living in urban disadvantaged areas with low self-perceived health. The intervention was delivered in primary care settings and community assets between 2015 and 2017 and consisted in 12 weekly sessions. The primary outcome was self-perceived health assessed in two ways: with the first item of the SF-12 questionnaire, and with the EQ-5D visual analog scale. Secondary outcomes were health-related quality of life, social capital, self-management, mental health and use of health services. Outcomes were assessed at baseline, post intervention and follow-up at 9 months after the end of the intervention. RESULTS: 390 people were allocated to the intervention group (IG) or the control group (CG) and 194 participants and 164 were included in the data analysis, respectively. Self perceived health as primary outcome assessed with SF-12-1 was not specifically affected by the intervention, but with the EQ-5D visual analog scale showed a significant increase at one-year follow-up only in the IG (MD=4.80, 95%CI [1.09, 8.52]). IG group improved health literacy in terms of a better understanding of medical information (- 0.62 [- 1.10, - 0.13]). The mental component of SF-12 improved (3.77 [1.82, 5.73]), and depressive symptoms decreased at post-intervention (- 1.26 [- 1.90, - 0.63]), and at follow-up (- 0.95 [- 1.62, - 0.27]). The use of antidepressants increased in CG at the follow-up (1.59 [0.33, 2.86]), while it remained stable in the IG. CONCLUSIONS: This study indicates that a group intervention with a strong social component, conducted in primary health care and community assets, shows promising effects on mental health and can be used as a strategy for health promotion among older adults in urban disadvantaged areas. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02733523 . Registered 11 April 2016 - Retrospectively registered.

Exercise referral schemes enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity among community-dwelling older adults from four European countries: protocol for the process evaluation of the SITLESS randomised controlled trial.

INTRODUCTION: SITLESS is a randomised controlled trial determining whether exercise referral schemes can be enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity in the long term, in community-dwelling older citizens. The intervention is complex and requires a process evaluation to understand how implementation, causal mechanisms and context shape outcomes. The specific aims are to assess fidelity and reach of the implementation, understand the contextual aspects of each intervention site, evaluate the mechanisms of impact, and explore perceived effects. METHODS AND ANALYSIS: Following the Medical Research Council guidance on complex interventions, a combination of qualitative and quantitative procedures is applied, including observational checklists and attendance registries, standardised scales (ie, Marcus's Self-Efficacy Questionnaire, Physical Activity Self-Regulation Scale and the Lubben Social Network Scale) at baseline, postintervention and follow-up assessments, semistructured questionnaires gathering contextual characteristics, and participant observations of the sessions. Semistructured interviews and focus groups with the participants and trainers are conducted at postintervention and during the follow-up to explore their experiences. Outcomes from the standardised scales are analysed as moderators within the impact evaluation. Descriptive results on context and perceived effects complement results on impact. The qualitative and quantitative findings will help to refine the logic model to finally support the interpretation of the results on the effectiveness of the intervention. ETHICS AND DISSEMINATION: The study design was approved by the respective Ethical Committee of Ramon Llull University, Southern Denmark, Northern Ireland and Ulm University. Participation is voluntary, and all participants are asked to sign informed consent before starting the study. A dissemination plan operationalises how to achieve a social impact by reaching academic and non-academic stakeholders. A data management plan describes the specific data sets and regulates its deposition and curation. All publications will be open access. TRIAL REGISTRATION NUMBER: NCT02629666; Pre-results.