Open access Protocol Urinary incontinence and sedentary behaviour in nursing home residents in Osona, Catalonia: protocol for the OsoNaH project, a multicentre observational study Pau Farrés-­Godayol ‍ ‍,1 Javier Jerez-­Roig ‍ ‍,1 Eduard Minobes-­Molina ‍ ‍,1 Meltem Yildirim ‍ ‍,1 Ester Goutan-­Roura ‍ ‍,2 Laura Coll-­Planas ‍ ‍,1,3 Anna Escribà-Salvans ‍ ‍,1 Miriam Molas-­Tuneu ‍ ‍,1 Pau Moreno-­Martin,1 Sandra Rierola-­Fochs ‍ ‍,1 Sergi Rierola-­Colomer,1 Montse Romero-­Mas ‍ ‍,1 Miriam Torres-­Moreno ‍ ‍,1 Jordi Naudó-Molist ‍ ‍,4 Dyego Leandro Bezerra de Souza ‍ ‍,1,5 Joanne Booth ‍ ‍,6 Dawn A Skelton ‍ ‍,6 Maria Giné-Garriga ‍ ‍7,8 To cite: Farrés-­Godayol P, ABSTRACT Jerez-­Roig J, Minobes-­Molina E, Strengths and limitations of this study Introduction Several studies have shown that physical et al. Urinary incontinence and activity (PA) levels and sedentary behaviour (SB) are sedentary behaviour in nursing ►► The first study to focus on the association between independent risk factors for many health-­related issues. urinary incontinence and sedentary behaviour (SB) home residents in Osona, Catalonia: protocol for the However, there is scarce evidence supporting the in the older institutionalised population and the larg- OsoNaH project, a multicentre relationship between SB and urinary incontinence (UI) est study analysing SB patterns in the older institu- observational study. BMJ Open in community-­dwelling older adults, and no information tionalised population with a gold standard measure 2021;11:e041152. doi:10.1136/ on any possible association in institutionalised older (activPAL3). bmjopen-2020-041152 adults. Stage I of this project has the main objective of ►► Mixed methods study (quantitative and qualitative ►► Prepublication history for determining the prevalence of UI and its associated factors approach) considering a wide range of variables to this paper is available online. in nursing home (NH) residents, as well as analysing the assess health, based on the biopsychosocial model. To view these files, please visit association between UI (and its types) and SB. Stage II ►► An initial cohort first assessed before the pandemic the journal online (http://​dx.​doi.​ aims to investigate the incidence and predictive factors of (from January to March 2020) will be followed up org/​10.​1136/​bmjopen-​2020-​ functional and continence decline, falls, hospitalisations, to analyse the impact of COVID-19 in nursing home 041152). mortality and the impact of the COVID-19 pandemic (NH) residents. PF-­G and JJ-­R contributed among NH residents. ►► Limitations include participation of NH residents or equally. Methods and analysis Stage I is an observational, legal guardians in research-­based studies, cognitive multicentre, cross-­sectional study with mixed methodology impairment that may affect information on some Received 04 June 2020 that aims to explore the current status of several health-­ independent variables that require the participant Revised 14 January 2021 related outcomes in NH residents of Osona (Barcelona, response and the potential increase in SB during the Accepted 24 March 2021 Spain). The prevalence ratio will be used as an association COVID-19 pandemic. measure and multivariate analysis will be undertaken using Poisson regression with robust variance. Stage II is a 2-­year longitudinal study that aims to analyse functional disseminated at conferences, meetings and through peer-­ and continence decline, incidence of falls, hospitalisations, reviewed journals. mortality and the impact of the COVID-19 pandemic on Trial registration number NCT04297904. © Author(s) (or their these outcomes. A survival analysis using the actuarial employer(s)) 2021. Re-­use method for functional decline and continence, evaluated INTRODUCTION permitted under CC BY-­NC. No every 6 months, and the Kaplan-­Meier method for falls, commercial re-­use. See rights hospitalisations and deaths, and Cox regression for Low birth rates and an increased life expec- and permissions. Published by multivariate analysis will be undertaken. tancy are transforming the age pyramid of BMJ. the European Union (EU); probably the Ethics and dissemination The study received the For numbered affiliations see following approvals: University of Vic - Central University most important change will be the marked end of article. transition towards an aged society, a charac- of Catalonia Ethics and Research Committee (92/2019 Correspondence to and 109/2020), Clinical Research Ethics Committee of teristic that is already evident in several EU Dr Eduard Minobes-­Molina; the Osona Foundation for Health Research and Education member states. In 2017, the 65+ population ​eduard.​minobes@​uvic.​cat (FORES) (code 2020118/PR249). Study results will be had an increase of 0.3% compared with the Farrés-­Godayol P, et al. BMJ Open 2021;11:e041152. doi:10.1136/bmjopen-2020-041152 1 Open access previous year, and an increase of 2.4% compared with the health outcomes, similarly prevalent in all countries. The previous 10 years, in fact people aged over 80 years old are last consensus defined frailty as ‘a clinical state in which increasing at a faster rate than any other age segment of there is an increase in an individual’s vulnerability for the EU population.1 This increase is linked to a growing developing an increased dependency and/or mortality demand for long-­term care, which represents a significant when exposed to a stressor’.8 overload on public health resources. One in four older Functional decline is one of the main health-­related adults will spend a period of their life in a nursing home issues that affect older adults because it limits their (NH), and the need for such care will persist until their autonomy and leads to dependency.33 In older adults, death.2 Older adults who live in an NH are the most frail functional capacity can be defined as the ability to carry of our society with high levels of functional limitations out basic activities of daily living (BADL).10 The associ- and physical dependence,3 4 and one-­third of them have ation between functional decline and UI could be bidi- cognitive impairment.5 rectional, which can lead to a cycle where continence The prevalence of urinary incontinence (UI) in Spain reduction results in functional decline, and functional is approximately 10% in women aged between 25 and decline leads to further decrease in continence.13 17 64 years old, and over 50% in those over 65 years old.6 Falls, though preventable, are common among older In NHs, this proportion is around 50% and is frequently adults, and the resulting injuries can threaten their associated with cognitive impairment, physical inactivity health, independence and everyday routines. Ageing is and immobility syndrome, among other factors.7 In this one of the main risk factors for falls, for this reason, older context, we can find a type of UI described as ‘functional’ adults have a high risk of injuries, increased dependence, in that it is caused by an inability to move to the toilet inde- disabilities and institutionalisation. All these outcomes pendently, due to a physical, communicative or cognitive are also risk factors for frailty.18 19 Several studies have problem (eg, dementia).8 Most older adults mistakenly shown that the transition from in-­home to institutional believe that incontinence is part of the normal ageing care is related to substantially higher mortality rates, as process and/or is an irresolvable problem.9 10 However, well as reduced physical and cognitive function.20 28 It is UI is a geriatric syndrome that represents an indicator of well known that hospital admission can affect the process frailty and quality of healthcare, as well as a risk factor for of usual ageing due to adverse health outcomes after pressure ulcers, falls, fractures and even urinary sepsis or hospitalisation, especially in terms of functional decline,34 death.11–13 mortality,20 21 frailty22 and cognitive impairment.23 NH residents are the least physically active of all Therefore, the aim of this study is to determine the older adults and spend most of their awake time seden- prevalence of UI and its associated factors, specifically tary.14 15 Doing regular physical activity (PA) limits the the association between UI types and SB patterns in development and progression of most prevalent chronic older people living in NHs in Osona, a region of Catal- diseases.16 However, the time spent in sedentary behaviour onia, Spain. Also, stage I of this project aims to analyse (SB) by older adults has increased considerably in the last the current status of health-­related outcomes, based on three decades17 and SB increases with age.18 SB has been the biopsychosocial model of health, and to describe the gaining recognition as a risk factor for specific health current interventions to reduce SB and increase PA, and conditions and reduced mobility, sometimes indepen- the control measures to manage UI by the NHs of Osona. dent of PA levels.19 A typical day for a resident will consist In addition to this, it aims to understand the experience in a sequence of periods of SB, light intensity PA (LPA) of having UI among residents and the experience of and moderate to vigorous intensity PA (MVPA).20 21 NH providing healthcare to these individuals among health residents spend an average of 79% of their day sedentary, professionals, using descriptive phenomenology. 20% in LPA and 1% in MVPA.22 On the other hand, the SARS-­CoV-2, called COVID- There is a consensus among researchers that low levels 19, has emerged as a worldwide pandemic.35 This virus of PA and prolonged patterns of SB could be direct risk has been shown to be particularly deadly for older factors for UI in older adults.23–26 A recent observational adults and those with certain underlying medical condi- study on the association between SB and UI in community-­ tions.36–39 In relation to deaths from COVID-19 in Spain, dwelling older women concluded that urgency urinary 87% of the reported deaths were 70 years or older and incontinence (UUI) was associated with significantly 95% presented comorbidity.40 The population living in increased average duration of SB bouts. The importance NHs, generally with older age and multiple comorbidi- of objective measurement of SB was highlighted and it ties, are the most vulnerable to COVID-19.41 In Catalo- was suggested that decreasing time in prolonged sitting nian NHs from 28 418 suspected cases, 11 560 confirmed may be a target intervention to reduce UUI.27 Researchers positive cases and 3055 deaths were reported until May conclude that there is a lack of complementary studies of 2020.42 43 Due to the vulnerability of NHs themselves to higher quality on the association between SB and UI.28–32 outbreaks of respiratory diseases44 45 and the frailty of Frailty is one of the most important concerns regarding NH populations, there is a need to analyse the impact of our ageing population as it is a leading contributor to COVID-19 on NH residents in terms of mortality, hospi- functional decline and early mortality in older adults.5–7 talisation, as well as other health, social and cognitive-­ Evidence grows that this state is linked to several relevant related variables. 2 Farrés-­Godayol P, et al. BMJ Open 2021;11:e041152. doi:10.1136/bmjopen-2020-041152 Open access Stage II aims to follow-­up the included cohort of stage I Eligibility criteria and analyse the incidence and predictive factors for func- All NH residents (male or female) aged 65 years or older tional decline, frailty, continence decline, falls, hospital- who lived in the institution permanently, with or without isations and mortality among older people living in NHs cognitive impairment, were included in the quantitative for a 2-­year period. The cohort first assessed before the part of the study. Exclusion criteria were subjects in a coma first diagnosis of COVID-19 in NHs will be followed up or palliative care (prognosis of short life), hospitalised and to identify the potential risk and protective factors for those who refused to participate in the study. For the qualita- mortality due to COVID-19 and the impact of this disease tive part of the study, inclusion criteria for older people were on functioning and hospitalisations. as follows: (1) voluntary participation in the study, (2) diag- nosed with UI for at least 6 months and (3) able to express themselves verbally. Inclusion criteria for NH professionals METHODS AND ANALYSIS were as follows: (1) voluntary participation in the study and Study design (2) caring older people with UI for at least 6 months. The present study follows the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Study procedures guidelines and consists of two stages46: In the beginning of the project (October–November 2019), ►► Stage I. Observational cross-­ sectional study on the the research team was trained, received standardised oper- prevalence of UI (and its types) and SB patterns and ating procedures and was calibrated to ensure the reliability the possible association between both issues in the of the data regarding anthropometry, handgrip test and older population living in NHs. Short Physical Performance Battery (SPPB) with its corre- ►► Stage II. Observational 2-­year longitudinal (cohort) sponding calculation of the interclass correlation coeffi- study on functional and continence status, falls, hospi- cient. After the calibration, a pilot study was conducted with talisations and mortality (including COVID-19 data) a minimum of 20 participants in January 2020, with the aim among NH residents. to check if the evaluations and tests were reliable. Before starting data collection, every NH director accepted the Stage I: prevalence of UI and its associated factors among NH participation in the project with a formal consent. After that, residents in Osona (Barcelona, Spain) the list of residents was obtained, and the individuals were Design selected according to inclusion/exclusion criteria. Then, Cross-­sectional study with mixed methodology. The the residents or their legal guardians were informed about starting month was September 2019, main data collection the project and those who accepted to participate signed the was conducted between January and March 2020 and, informed consent. The assessment procedure started with after data analysis, the study is planned to be finalised in the placement of the activPAL3 activity monitor (PAL Tech- May 2021. nologies, Glasgow, UK), a reliable and valid device consid- Setting and location ered as a gold standard to record and analyse the SB.48–50 The present study was conducted in NHs of Osona. The device was worn on the anterior medial part of the According to the Catalonia Government, there are 19 right thigh, sealed with a flexible nitrile cover and adhered registered NHs: 14 private NHs with state-­ subsidised to the skin with a hypoallergenic adhesive dressing. The places and 5 totally private NHs. The first contact with device captured data continuously during both awake the NHs was done by email and phone call to explain the and sleeping time, for 7 consecutive days. Sociodemo- project, resolve any queries and send them the partici- graphic information was obtained from the NH regis- pation documents for the study if they are interested in ters. Information on the continence status and other taking part. conditions were checked with the residents’ caregivers. Cognitive status was assessed in all individuals and a more Patient and public involvement extended questionnaire on quality of life, incontinence, There was no patient or public involvement in the design lower urinary tract symptoms, depressive and anxiety and conduct of stage I. symptoms, social network and loneliness was applied to residents with cognitive capacity.51 The approximate time Sample size of application of the physical tests and the questionnaire The calculation of the study sample was based on the to the participant was 30–45 min. In case of fatigue, the preliminary data from the pilot study. Calculating the participant was offered the possibility of interrupting or sample from the difference between variables (presence stopping the assessment whenever he/she wished. of IU or not and the mean of the total time in hours of SB), an absolute precision of the 5% and a significance level Data collection of the 5%, the sample to estimate the association between Section H of Minimum Data Set (MDS) V.3.052 was used IU and SB was 120 subjects. Considering a 30% possible to assess the presence of UI and other bladder and non-­response rate, the final sample corresponds to 145 bowel conditions. When a resident had preserved cogni- subjects. A simple random sampling was undertaken. The tive capacity to answer questionnaires, the continence exclusion criteria will be given in a flow chart.47 status was checked with the International Consultation Farrés-­Godayol P, et al. BMJ Open 2021;11:e041152. doi:10.1136/bmjopen-2020-041152 3 Open access on Incontinence Questionnaire Urinary Incontinence– through the Lubben Social Network Scale65 and loneli- Short Form (ICIQ UI-­ SF), validated to Spanish.53 ness through the 6-­ item De Jong-­ Gierveld Loneliness According to the MDS and the ICIQ UI-­SF, the type of UI Scale.66 67 was determined: stress, urgency, mixed and functional. Anthropometric variables included weight (kg), height The number of absorbents (pads/diapers) used daily (m), body mass index (kg/m2), arm circumference (cm), was also considered. In addition, information on lower waist circumference (cm), hip circumference (cm) and urinary tract symptoms was collected using the Interna- calf circumference (cm). These measurements were tional Prostate Symptoms Score (IPSS).54 To evaluate SB, obtained using a Seca 213 measuring device (Seca Mediz- the variables of steps, duration in minutes of SB periods, inische Messsysteme und Waagen, Hamburg, Deutsch- total time in SB, SB bouts, total time in standing posi- land) and a measuring tape. Measures related to body tion and walking in hours, and transitions from sitting to composition were reported as a percentage (%) of body standing were taken with the activPAL3 activity monitor fat, % of fat-­free mass and % of body water, using a Tanita (PAL Technologies, Glasgow, UK) for 7 consecutive days. TBF-300 bioimpedance device (Tanita Institute, Tokyo, The device placement was on the anterior and middle of Japan).68 Finally, the nutritional status was evaluated by the right thigh, or on the unaffected leg thigh in cases of the Mini Nutritional Assessment Test (MNA),69 consid- stroke. ered as a gold standard method for evaluating nutritional Sociodemographic variables such as age, gender, date status in old people. of birth, date of institutionalisation, number and type In the qualitative part of the study, descriptive phenom- of deliveries (vaginal or caesarean), level of education, enology will be used, as it is one of the leading method- marital status, chronic conditions (high blood pressure, ologies used in social sciences and healthcare research diabetes, cancer, lung disease, stroke, dementia, Parkin- in order to understand the lived experiences of individ- son’s, osteoporosis, kidney failure, dyslipidaemia, cardiac uals.70 Therefore, to understand the experience of having disease and mental illness), history/current tobacco use UI among residents and to explore health professionals’ and alcohol consumption urinary tract infection in the experience of providing health services to residents with last 30 days, bone fracture in the last year, hospitalisation UI, descriptive phenomenology is planned to be consid- in the last year, medication and normal routine blood ered as the methodological approach of the qualitative analysis from NH records (biochemical data for vitamin part. We aimed for the participants to be heterogeneous D, albumin, pre-­albumin and C-­reactive protein) were in terms of their descriptive characteristics (eg, age, recorded. Regarding health-­related variables, delirium, gender, duration and level of incontinence among resi- ulcers (any type), functional ability (modified Barthel dents; gender and years of experience with residents with Index),55 56 cognitive status (Pfeiffer Scale),51 faecal incon- UI among health professionals). tinence (according to MDS V.3.0), lower tract urinary During the initial plan, two semistructured interview symptoms (through the IPSS), falls during the last year guides will be used: one with residents and one with health (number, places and consequences, from NH records), professionals. The guides were created by the researchers physical capacity using the Short Physical Performance with two general research questions in mind: (1) What is Battery (SPPB),57 mobility (Rivermead Mobility Index),58 your experience of having UI and what effects does it have frailty (Clinical Frailty Scale)59 and quality of life using on everyday life? (2) How is the experience of providing the self-­reported questionnaire EUROQOL-­ 5D (EQ-­ healthcare to residents with UI and what are the difficul- 5D)60 were assessed. To ensure a possible comparison ties experienced in this aspect? Individual interviews were with other studies on sarcopenia/frailty, the handgrip considered as the data collection method to use with resi- strength measured by JAMAR Plus Digital Hand dyna- dents due to the delicate character of the experienced mometer61 and any unintended weight loss in the last year problem; meanwhile, with health professionals, a focus (more than 4.5 kg or more than 5% of previous weight in group was considered as an ideal data collection method the last year) were recorded. The approximate consump- and facilitates remembering forgotten experiences. In tion liquids (water and drinks in millilitres and types of both interviews, the data collection process will be termi- drinks) were collected over a 24-­hour period, completed nated after data saturation is reached, in other words, by the residents themselves if their cognitive capacity was when no new topic arises during the interviews.71 As sufficiently preserved, or by health professionals of the recommended by Sandelowski,72 the sample size must be NHs. The total number of daily use medications was regis- large enough to allow the unfolding of a new and richly tered, as well as the types of medications, according to textured understanding of the studied phenomenon, but the international Anatomical Therapeutic Chemical classifi- small enough to be able to do a deep and case-­oriented cation system (ATC).62 In addition, psychosocial factors analysis of the qualitative data. In the qualitative analysis were considered in all residents with sufficient cognitive of the obtained data, Colaizzi’s phenomenological data capacity to answer questionnaires: number of monthly analysis method will be considered. This method was visits from friends/family, according to the caregivers, as largely influenced by Husserl’s descriptive phenomeno- well as the Yesavage Geriatric Depression Scale (5-­GDS)63 logical approach and will allow the researchers to discover to assess depressive symptoms, the Hospital Anxiety and the fundamental structures of the phenomena which is Depression Scale (HADS) for anxiety,64 social networks being investigated.73 4 Farrés-­Godayol P, et al. BMJ Open 2021;11:e041152. doi:10.1136/bmjopen-2020-041152 Open access The feasibility of the qualitative dimension was adversely for information on functional decline, frailty, continence affected by the physical restrictions applied in NHs due status, hospitalisations, mortality, diagnosis and suspected to the COVID-19 pandemic as face-­ to-­ face interviews cases of COVID-19, COVID-19 containment measures with residents and focus groups with health professionals within NHs and changes in the medication of their resi- were considered unsafe for both participant groups due dents. Data related to falls will be collected through a to increased risk of transmission. For this reason, online continuous prospective register in every institution. video conferencing was planned to be used during the collection of the qualitative data. However, it is foreseen Patient and public involvement that conducting individual interviews via video confer- There was no patient or public involvement in the design encing with residents will decrease both the applicability and conduct of stage II. of the interview and the quality of the data obtained due to their unfamiliarity with this virtual method and the Sample size possible auditory and/or visual limitations that they may According to a 2-­year longitudinal study conducted by have. Thus, it was decided to exclude the dimension of Jerez-­Roig et al44 in institutionalised older people, an UI experiences among residents and only have individual initial sample of 280 people is powered to detect prog- interviews with healthcare professionals via video confer- nostic factors of functional decline. encing instead of creating online focus groups, which will Eligibility criteria be relatively challenging to manage virtually. NHs residents (male or female) aged 65 years or older who live in the institution permanently will be included. Statistical analysis Subjects in coma or palliative care (prognosis of short First, descriptive analysis will be undertaken indicating life) will be excluded. For the study of functional decline, absolute and relative frequencies for categorical vari- residents with limitations in all basic activities of daily ables and mean and SD for quantitative variables. Before living will be excluded from the study. For the study of doing the bivariate analysis, a subanalysis of the minimum continence decline, the participants who have a urinary number of days with the activPAL that are necessary to catheter fitted, or ostomy, as well as those with total UI have a reliable data record on SB will be performed, defined by Section H of MDS V.3.052 at baseline will be following the PA procedure performed by Reid et al.74 excluded. For analysing the incidence of falls, those Subsequently, the bivariate analysis will be applied subjects who do not walk independently (with or without through the χ2 test (or Fisher’s test) and the linear χ2 aids) will be excluded. test in case of dichotomous or ordinal variables, as well as the Student’s t-­test for quantitative variables. As an asso- Study procedures ciation measure, the prevalence ratio will be used, with a From the baseline of January 2020 to March 2020, every confidence level of 95%. The multivariate analysis will be 6 months the data will be collected, until accomplishing undertaken through the Poisson regression with robust the 2-­year follow-­up, in March 2022. The data are provided variance. by the NH staff and the NHs who previously agreed to participate in the study signing the informed consent Stage II: incidence and predictor factors of functional and to access the records and the variables of mortality and continence decline, falls, hospitalisations, mortality among causes, hospitalisations and causes, falls, functional older people in NHs: a 2-year cohort study capacity evaluated by means of the Barthel scale, frailty Design evaluated by the Clinical Frailty Scale, COVID-19 diag- Stage II of the OsoNaH project is a longitudinal prospec- nostic by test (PCR or serological), suspected case of tive 2-­year study and follows the STROBE guidelines.46 COVID-19 and modifications in the medication in the The starting month was January 2020 and, following last 6 months. Due to COVID-19 restrictions, interviews the data analysis, the study is planned to be finalised in are conducted by phone call or email with the NH staff December 2022. Data will be collected every 6 months every 6 months. over 2 years focusing on functional decline, frailty, conti- nence status, hospitalisations, mortality, diagnosis and Data collection suspected cases of COVID-19 and changes in the medica- Functional status will be assessed by the modified (5-­point tion of their residents in the NHs, already assessed at the Likert scale) Barthel’s Index. Continence status will baseline from January to March 2020. The information is be assessed using Section H of MDS V.3.0. Falls will be provided by the NH staff and the NH records according registered continuously taking into account the date, to the COVID-19 health measures, by phone call or email location and consequences of falls. Dates and causes of avoiding direct contact with the NH staff. hospitalisations and mortality (dates and causes) will also be registered retrospectively during the 6-­month assess- Setting ments. For the COVID-19-­related variables, the following NHs and residents participating in stage I will be followed information will be collected: date and results of diag- up over the next 2 years. Every 6 months through inter- nosis tests of COVID-19 (PCR or serological antibody views with the professionals of the institutions will be asked test), suspected case (symptoms of cough, fever and/ Farrés-­Godayol P, et al. BMJ Open 2021;11:e041152. doi:10.1136/bmjopen-2020-041152 5 Open access or breathing difficulties during the previous 6 months) Author affiliations 1 and room lockdown (duration in days). The levels of Research Group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O), Faculty of Health Sciences and Welfare, Centre for Health frailty of the resident will be assessed with the Clinical and Social Care Research (CESS), University of Vic-­Central University of Catalonia Frailty Scale.59 Finally, any new comorbidity diagnosis as (UVic-­UCC), Vic, Barcelona, Spain well as any change in the regular medication (registered 2 Research group on Tissue Repair and Regeneration Laboratory (TR2Lab), Faculty according to ATC classification62) in the last 6 months will of Health Sciences and Welfare, Centre for Health and Social Care Research (CESS), be assessed. University of Vic-­Central University of Catalonia (UVic-­UCC), Vic, Barcelona, Spain 3 Fundació Salut i Envelliment (Foundation on Health and Ageing), Autonomous University of Barcelona, Barcelona, Spain Statistical analysis 4 Research group on Mental Health and Social Innovation (SAMIS), Faculty of The actuarial method will be used to analyse functional Health Sciences and Welfare, Centre for Health and Social Care Research (CESS), and continence decline throughout the 5-­wave cohort. University of Vic-­Central University of Catalonia (UVic-­UCC), Vic, Barcelona, Spain 5 Department of Collective Health, Federal University of Rio Grande do Norte, Natal, The Kaplan-­Meier method will be used for falls, hospi- Brazil talisations and deaths. Log-­rank test will be applied for 6 Research Centre for Health (ReaCH), School of Health and Life Sciences, Glasgow bivariate analysis. Those variables with p<0.25 and vari- Caledonian University, Glasgow, UK 7 ables ‘age’ and ‘sex’ will be considered susceptible for Faculty of Psychology, Education and Sport Sciences Blanquerna, Ramon Llull testing in the multiple model. Multivariate analysis will University, Barcelona, Spain 8 Faculty of Health Sciences Blanquerna, Ramon Llull University, Barcelona, Spain be performed using Cox regression. Forward selection will be used to introduce covariables in the model, first Twitter Pau Farrés-­Godayol @PauFarrs, Javier Jerez-­Roig @javierjerezroig, Meltem introducing those variables with higher HR values and Yildirim @mltmyldrm9 and Dawn A Skelton @LaterLifeTrain & @GCUResearch observing the behaviour and adjustment of the model Contributors PF-­G, JJ-­R, MG-­G and EM-­M were involved in designing of the (stepwise forward). Risk measurements will be presented study and the writing of the manuscript. AES, MM, PM-­M, SR-­C, SR-­F and MY were for HR, with the respective CI and p values. Finally, involved in the acquisition of data. DB participated in the design and the sample the proportionality test will be carried out for the final size calculation. EG-­R, LC-­P, MR-­M, MT-­M, JN-­M, DB, JB, DS and the rest of authors reviewed drafts of the paper and approved the final draft. model, followed by Schoenfeld residual analysis to verify Funding This work was supported by the Hestia foundation (grant number validity of Cox’s semiparametric model. The ROC curve BI-­CHAISS-2019/003) and the Col·legi de Fisioterapeutes de Catalunya (grant will be analysed to determine the predictive ability of the number R03/19). created functionality decline index. The inferential statis- Competing interests None declared. tical analysis will be performed at a 95% confidence level. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research. Patient consent for publication Not required. ETHICS AND DISSEMINATION Provenance and peer review Not commissioned; externally peer reviewed. The study received the following approvals: University of Open access This is an open access article distributed in accordance with the Vic - Central University of Catalonia (UVic-­UCC) Ethics Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-­commercially, and Research Committee (92/2019 and 109/2020), Clin- and license their derivative works on different terms, provided the original work is ical Research Ethics Committee of the Osona Founda- properly cited, appropriate credit is given, any changes made indicated, and the use tion for health research and education (FORES) (code is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. 2020118/PR249). On December 2019, the UVic-­UCC’s ORCID iDs Ethics and Research Committee approved an amend- Pau Farrés-­Godayol http://​orcid.​org/​0000-​0002-​6335-​9825 ment to the project that consisted of adding question- Javier Jerez-­Roig http://​orcid.​org/​0000-​0002-​1968-​4452 naires on physical activity, loneliness, social network and Eduard Minobes-­Molina http://​orcid.​org/​0000-​0002-​0457-​2503 Meltem Yildirim http://​orcid.​org/​0000-​0002-​9699-​3099 number of visits to residents. Later, modifications due to Ester Goutan-­Roura http://​orcid.​org/​0000-​0003-​0990-​9387 COVID-19 restrictions were evaluated and approved by Laura Coll-­Planas http://​orcid.​org/​0000-​0001-​5204-​8717 the same Ethics and Research Committee on November Anna Escribà-Salvans http://​orcid.​org/​0000-​0003-​3419-​7174 2020 with registry number 009. Miriam Molas-­Tuneu http://​orcid.​org/​0000-​0002-​6743-​2161 Sandra Rierola-­Fochs http://​orcid.​org/​0000-​0003-​3677-​975X Every NH director accepted the participation in the Montse Romero-­Mas http://​orcid.​org/​0000-​0002-​8079-​1433 project with a formal consent. Then, NH staff were Miriam Torres-­Moreno http://​orcid.​org/​0000-​0002-​7808-​043X informed about the project and the ones who accepted Jordi Naudó-Molist http://​orcid.​org/​0000-​0003-​3731-​2350 to participate signed the informed consent. Finally, the Dyego Leandro Bezerra de Souza http://​orcid.​org/​0000-​0001-​8426-​3120 Joanne Booth http://​orcid.​org/​0000-​0002-​7870-​6391 selected residents or their legal guardians were informed Dawn A Skelton http://​orcid.​org/​0000-​0001-​6223-​9840 about the project and those who accepted to participate Maria Giné-Garriga http://​orcid.​org/​0000-​0003-​4449-​3524 signed the informed consent. 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