Gual et al. BMC Geriatrics (2020) 20:321 https://doi.org/10.1186/s12877-020-01694-6 STUDY PROTOCOL Open Access IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors Neus Gual1, Laura Mónica Pérez1, Carmina Castellano-Tejedor1,2* , Pilar Lusilla-Palacios3, Judith Castro1, Luís Soto-Bagaria1, Laura Coll-Planas4,5, Marta Roqué4,5, Ana Belen Vena6, Benito Fontecha7, Jose M. Santiago7, Eva Månsson Lexell8,9, Carlos Chiatti8,9, Susanne Iwarsson8,9 and Marco Inzitari1,2 Abstract Background: Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), as a person-centered complex intervention, aimed to empower and motivate, and could be a resource to improve rehabilitation outcomes for older stroke survivors. The IMAGINE project aims to assess the impact of MI, as a complement to standard geriatric rehabilitation, on functional improvement at 30 days after admission, compared to standard geriatric rehabilitation alone, in persons admitted to geriatric rehabilitation after a stroke. Secondary objectives include assessing the impact of MI on physical activity and performance, self-efficacy, safety, cost-utility, participants’ experiences and functional status at 3 months. Methods: We will conduct a multicenter randomized clinical trial in three geriatric rehabilitation hospitals in Spain. Older adults after mild-moderate stroke without previous severe cognitive impairment or disability will be randomized into the control or intervention group (136 per group, total N = 272). The intervention group will receive 4 sessions of MI by trained nurses, including the design of a personalized rehabilitation plan agreed between stroke survivors and nurses based on stroke survivors´ goals, needs, preferences and capabilities. Main outcome will be the Functional Independence Measure (FIM). In-hospital physical activity will be measured through accelerometers and secondary outcomes using validated scales. The study includes a process evaluation and cost- utility analysis. (Continued on next page) * Correspondence: ccastellano@perevirgili.cat 1 REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d’Hebron Institute of Research, Barcelona, Spain 2 Autonomous University of Barcelona, Bellaterra, Spain Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Gual et al. BMC Geriatrics (2020) 20:321 Page 2 of 12 (Continued from previous page) Discussion: Final results are expected by end of 2020. This study will provide relevant information on the implementation of MI as a rehabilitation reinforcement tool in older stroke survivors. A potential reduction in post- stroke disability and dependence would increase person’s health-related quality of life and well-being and reduce health and social care costs. IMAGINE has the potential to inform practice and policymakers on how to move forward towards shared decision-making and shared responsibilities in the vulnerable population of older stroke survivors. Trial registration: ClinicalTrials.gov: NCT03434938, registered on January 2018. Keywords: Stroke, Geriatrics, Rehabilitation, Functional recovery, Physical activity, Motivational interviewing, Adherence, Clinical trial Background post-stroke psychological problems, such as cognitive- Despite the positive advances obtained through acute behavioral techniques and the improvement of social treatments, stroke continues to be the leading cause of support networks [15, 16]. Nonetheless, most interven- long-term disability in adults [1], reaching up to 40% of tions are designed to be performed one month after the residual disability, and representing a huge burden for stroke and not during hospitalization in the acute phase, health and social systems, as well as for families [2]. thus valuable time to begin and engage in rehabilitation Rehabilitation is crucial to reduce the gap between the is delayed [15]. Accordingly, new approaches are persons’ disability and the demands of their environment warranted. [3]. In this sense, there are different interventions that Due to the population pyramid change and to the focus on the different aspects of rehabilitation: some optimization of primary and secondary prevention treat- focus more on physical activity others on cognitive is- ments, the mean age of people with incident and fatal sues and some on regaining activities of daily living. stroke has increased and is around 70.4 years old [2], Post-stroke rehabilitation entails a cyclical process, [17]. Older adults have more frequently physical and which includes: 1) identification of the person’s needs; 2) mental comorbidities, and a pre-stroke reduced set of realistic and reachable goals; 3) implementing in- functional capacity that can be associated with social terventions according to these goals; and 4) follow-up, difficulties (i.e., living alone or with an old partner, low with potential revision of the goals and interventions [3]. social support) which increase the risk of disability, Early rehabilitation [4, 5] and shared-goal setting be- institutionalization and death [18, 19]. Despite the high tween stroke survivors and healthcare professionals, incidence of stroke in the aging population, older people based on the person’s preferences, values, previous rou- with comorbidity and reduced functional ability have tines and environment [6, 7], increase the odds of often been excluded from clinical studies precisely be- achieving better results [3]. Beneficial aspects include cause of their high vulnerability and, therefore, it is ne- higher adherence to rehabilitation, increased personal cessary to increase research improving health outcomes satisfaction, shorter inpatient stays and greater goal at- in this segment of the population. tainment [6, 8]. This is also in line with the International Motivational interviewing (MI) is a person-centered Classification of Functioning, Disability and Health (ICF) method where professionals and patients collaborate, [9], which promotes patient-professionals communica- utilizing a goal-oriented style of communication. This tion, and the terminology of which can be used to struc- method gives particular attention to the language of ture assessments, goals and plan interventions [10, 11]. change [20]. MI can be easily adapted to different However, patient participation in the process of goal set- healthcare settings and is known to strengthen personal ting is not standard clinical practice and even less so in motivation, empowerment, self-efficacy and commit- geriatric rehabilitation, despite the fact that older per- ment to specific personal goals by exploring and identi- sons need, due to their several comorbidities and various fying the individual’s values and preferences [20]. MI has degrees of frailty, more guidance in defining their re- also demonstrated efficient in promoting physical activ- habilitation goals [12]. ity, fostering treatment adherence [20, 21], and Further research has shown that psychological prob- improving rehabilitation outcomes [20–22]. MI has been lems such as depression, apathy, anxiety, emotional and applied in frail older adults with mobility limitations, post-traumatic stress disorder are frequent complica- showing that it is safe and has a potential cost- tions following a stroke [13], reducing the motivation to effectiveness as a rehabilitative person-centered ap- engage in rehabilitation [13, 14]. Several studies have proach [23]. However, evidence of its effectiveness in tested non-pharmacological interventions to reduce older stroke survivors is lacking. Gual et al. BMC Geriatrics (2020) 20:321 Page 3 of 12 The IMAGINE study aims to investigate the effects Population of enriching usual geriatric rehabilitation with an Older stroke survivors admitted to one of the participat- adapted MI approach on different outcomes related ing geriatric rehabilitation units. Inclusion and exclusion to functional and clinical impact, persons’ satisfac- criteria are presented in Table 1. tion during hospitalization and cost-utility. We ex- pect that the IMAGINE study will add a relevant Randomization and blinding contribution for the implementation of this interven- After inclusion in the study and obtaining informed con- tion in older stroke survivors needing rehabilitation. sent, participants will be randomized centrally to inter- Accordingly, this study should inform practice and vention or control group in a concealed allocation policy makers on how to move forward towards manner. That means that, in each study site, a re- shared decision making and shared responsibilities in searcher not involved in the assessments will access the a vulnerable population such as older stroke survi- OxMaR minimization software through a secure web ac- vors [24]. With these aims, several hypothesis have cess [25], and obtain the participant’s random treatment been put forward: allocation. Randomization will be based on the minimization method, which has proven to provide bal- 1. MI, conducted during in-patient geriatric rehabilita- anced allocation of study participants in small trials, with tion with older stroke survivors will result in an im- respect to prognostic participant characteristics [26]. For provement in functional status at 30 days and 3 each participant, treatment allocation will partially de- months, compared to standard geriatric rehabilita- pend on the characteristics of the already enrolled par- tion alone. ticipants [25]. The prognostic factors included in the 2. The MI intervention will induce a statistically and minimization algorithm are: study site, gender (male or clinically significant increase in physical activity female), and type of stroke (ischemic or hemorrhagic). during the stay in the geriatric rehabilitation Due to the nature of the intervention, participants can- department, and an improvement in physical not be blinded to allocation, but will be strongly advised performance, compared to controls. not to disclose their allocation status at any assessments. 3. The increase in physical activity and performance The assessments will be conducted by a healthcare pro- will be dose-correlated with the improvements in fessional (physiotherapist) blinded to treatment alloca- functional status. tion. The assessors are encouraged to maintain the blind 4. The intervention will result in a more favorable and as far as possible, nonetheless, the assessor must report satisfying experience with care during if the participant allocation was revealed. hospitalization for the participants, caregivers and professionals involved. 5. Participants will increase their self-efficacy. Intervention 6. The intervention will be a cost-effective strategy The aim of the MI intervention, which will be integrated to improve participant outcomes at an accept- to the standard geriatric rehabilitation provided in the able cost (or even with no relevant incremental participating centers, is to empower, motivate and en- costs). gage the person in planning and participating in the 7. The intervention will be safe for the stroke rehabilitation plan. The adaptation of the MI inter- survivors. An increased number of adverse vention is based on a previous pilot study carried out events potentially associated to geriatric with older stroke survivors during geriatric rehabilita- rehabilitation and exercise will not be observed tion, in one of the centers involved in the IMAGINE in the intervention group compared to control study [27]. Figure 1 shows the logic model of the group intervention. MI will be provided at the hospital ward, either in the person’s room or in an office nearby, according Methods to their preferences and mobility. MI will be struc- Design tured in four sessions: session 1 will be held one Multicenter randomized clinical trial, with blinded out- week from admission; session 2 within 6 days after come assessment. the first session; session 3 at 1 week from the second session; and session 4 will be carried out pre- discharge. Setting The common goals for all sessions are: Geriatric rehabilitation units of three post-acute care hospitals in Catalonia, Spain. 1) To engage the stoke survivor in his/her care. Gual et al. BMC Geriatrics (2020) 20:321 Page 4 of 12 Table 1 Inclusion and exclusion criteria Inclusion criteria Exclusion criteria 1. Older adult (> 60 years old) 1. Previous diagnosis of dementia (ascertained from medical records) 2. Admitted to the geriatric rehabilitation unit after a mild-moderate 2. Severe post-stroke cognitive impairment (Pfeiffer SMPQ> 7 errors) stroke (ischemic or hemorrhagic, stroke severity at admission assessed 3. Persistent delirium (> 7 days) after admission in the rehabilitation unit by National Institute of Health Stroke Severity (NIHSS) scale < 17 points) 4. Previous severe disability in activities of daily living (pre-stroke Barthel 3. Able to provide informed consent, personally or by caregiver. index < 20/100 points) 5. Severe stroke which might limit recovery (NIHSS> 16) 6. Aphasia or other problems hampering communication 7. Advanced and/or terminal condition (life expectancy not exceeding 6 months). 2) Collaborative co-creation of a personalized rehabili- MI involves the use of different core communication tation plan, which would complement the routine skills: 1) to ask open questions; 2) to affirm the person’s geriatric rehabilitation. particular strengths, abilities, good intentions and efforts; 3) Reinforce engagement and adherence to the plan to 3) to use reflective listening; 4) to summarize the situ- maintain behavior change and functional ation, and 5) to inform and advise with permission, improvement at 3 months. which is useful to help people to reach their own con- clusions about the relevance of any information the The emphasis on each of the different goals will vary practitioner provides [20]. Each session will follow a according to each MI session (see Fig. 2). Although this semi-structured format to ensure homogeneity, while intervention focuses on physical training and function- allowing tailoring. Content will generally include: 1) ing, during the MI sessions people will be also encour- Creating engagement with the stroke survivor by explor- aged to perform other recreational, socializing, relaxing ing his/her preferences, values and goals, as well as his/ or similar activities during hospitalization, always ac- her knowledge and expectations about stroke rehabilita- cording to individual preferences and objectives. tion and recovery, 2) enhancing motivation by evoking Fig. 1 Logic model of IMAGINE project Gual et al. BMC Geriatrics (2020) 20:321 Page 5 of 12 Fig. 2 Structure and main contents of MI sessions strengths and abilities of the person, 3) follow-up and and outcome indicators and general staff/patients ratios reinforcement, and 4) adapting the plan to the improved are marked by the Department of Health [29]. Standard abilities and to home setting. As a practical milestone, geriatric rehabilitation includes a multidisciplinary and during the second session the stroke survivor will estab- individualized rehabilitation plan, which incorporates lish tailored goals to complement standard rehabilita- physiotherapy, occupational therapy and speech therapy. tion, aimed at increasing involvement in self-care and This plan is established after a comprehensive multidis- daily living activities. When appropriate, in some cases ciplinary geriatric assessment, and shared through the debriefing with other professionals involved in the re- electronic health records. habilitation (physical therapists, occupational therapist or nursing staff) will be scheduled, to tailor and adjust Outcome assessments the rehabilitation plan considering the functional situ- All outcome assessments will be performed by trained ation. Figure 2 displays the structure of each session and physiotherapists, certified to use the Functional specific criteria to conduct the additional interview be- Independence Measure (FIM) and blinded to treatment tween sessions three and four in case of external or in- allocation. Table 2 summarizes assessment tools admin- ternal modulators (which might have undermined the istered in this study and the specific assessment time pe- interviews). MI will be delivered by nurses trained riods of each one. We will monitor and record whether through a certified MI course, and additional coaching group allocation is revealed during the outcome by a psychiatrist who is a certified MI trainer will be of- assessment. fered to them throughout the intervention period (two group meetings per year and on demand individual Primary outcome measures sessions). During the study, quality control of the MI Functional Independence Measure (FIM), validated for sessions using Motivational Interviewing Treatment In- use in stroke survivors [30], is a sensitive and compre- tegrity (MITI) Code 3.1.1 [28] will be performed through hensive tool to assess the level of independence in basic video recording of a random selection of sessions. activities of daily living, which is considered the golden standard for stroke rehabilitation. The scale includes 18 Control group items, grouped into 2 subscales: 1) motor and 2) cogni- The control group will receive standard geriatric re- tion. Each item is scored on a 7-point ordinal scale (1–7, habilitation. Routine geriatric rehabilitation in post-acute higher values indicating more independence). Combined centers in Catalonia is homogeneous in terms of process motor (13–91 points) and cognitive (5–35 points) Gual et al. BMC Geriatrics (2020) 20:321 Page 6 of 12 Table 2 Schedule of enrolment, interventions, and assessments for the IMAGINE study Gual et al. BMC Geriatrics (2020) 20:321 Page 7 of 12 subscale scores provide the total score (18–126 points; 15 items (0–15 points; worse – best) [38] and higher values indicating more independence). In this the mental wellbeing with the Warwick- study, a version translated into Spanish was Edinburgh Mental Well-being Scale (WEMWBS), administered. which includes 14 questions with answers coded from 1 ‘Never’ to 5 ‘Always’ (14–70 points, worst Secondary outcome measures – best) [39].  Duke Social Support Index 11 items (DUKE-UNK-  Complementary measures of function/disability. The 11) will be used to assess social support and effective Modified-Rankin Scale (m-RS) is a short measure of social contacts during the rehabilitation process, disability and dependence, routinely used for 3 effective caregiver at home, and perceived social months clinical follow-up, and rated in an ordinal support (11–55 points; lower – higher social scale with 6 categories ranging from zero (no symp- support) [40]. toms) to five (complete physical dependence). A sev-  Care results. We will collect data on length of stay enth category can be added to signify death [31]. In (days), discharge destination (home, nursing home, this study, a version translated into Spanish was long-term care, acute hospital, death), and hours of administered. rehabilitation.  In-hospital physical activity will be measured once  Participation in leisure activities during admission through accelerometers, placing ActivPAL® devices and after-discharge, reported by nurses, stroke survi- on the preserved leg during 7 consecutive in- vors and / or caregivers, will be collected. hospital days, to measure mainly time spent sitting  Rehabilitation efficiency. Scores will be computed in and standing. This device has been validated in post- terms of improvement of FIM/length of stay. acute stroke samples [32, 33].  Quality of life. A generic measure of quality of life  Physical performance improvement will be will be obtained using the EQ-5D-5L tool, which in- measured using the Spanish validated version of the cludes two components. A health state description Short Physical Performance Battery (SPPB) (0–12 comprises 5 items assessing the dimensions of mo- points, worse–best), which includes sub-tests of bal- bility, self-care, usual activities, pain/discomfort, and ance, strength and gait speed [34]. anxiety/depression and evaluation, via categorical  Adverse events registration will include: falls, questions. An evaluation part using a Visual Ana- fractures, cranial traumatism, pain (Visual Analogue logues Scale for retrieving from respondents an Scale from 0 to 10 points), cardiovascular events overall judgment on their health in a scale from 0 to (angina, myocardial infarction, TIA, stroke), 100 [41, 42]. aspiration pneumonia/respiratory infections, readmissions to acute hospitals and death. Covariates assessed at admission  General Self-Efficacy scale [35] is a 10-item tool de- signed to assess optimistic self-beliefs to cope with a  Socio-demographic variables: age, gender, civil and variety of difficult demands in life. This scale is dir- marital status. ectly correlated to emotion, optimism and work sat-  Clinical data: Stroke characteristics (ischemic/ isfaction. The total score ranges between 10 and 40, hemorrhagic, Oxfordshire CSPC, acute treatment, with a higher score indicating more self-efficacy. etiology) clinical variables such as chronic diseases Negative correlations are found with depression, and comorbidity measured by a Spanish translated stress, health complaints, burnout, and anxiety. version of the Charlson index [43] will be collected.  Montreal Cognitive Assessment (MOCA) [36] is a In addition, type and number of pharmacological brief instrument recommended for cognitive treatment, nutritional status with the Spanish impairment (CI) screening in people who have validated version of the Mini Nutritional suffered a stroke or TIA. It is sensitive to changes in Assessment-Short form (MNA-sf) [44]. acute temporary CI after mild stroke/TIA [37]. The test assesses visuospatial abilities, short-term mem- Procedure ory, executive functions, language and fluency, ab- Table 2 depicts full procedures of the project. straction thinking, orientation, attention, In case of discharge before 30 days, the follow-up as- concentration, and working memory. The scale in- sessment will be performed the day of discharge, always cludes 10 questions (total score range 0–30). Higher registering the date of the assessment. In case of un- scores indicate higher cognitive performance. planned discharge (e.g. to emergency/acute hospital), we  Mental health: Depressive symptoms by means of will collect at least routine available data collected in the the Yesavage Geriatric Depression Scale (GDS) rehabilitation unit and administrative data. The 3 Gual et al. BMC Geriatrics (2020) 20:321 Page 8 of 12 months assessment will be performed either at an outpa- Sample size calculation & statistical analysis tient’s clinic or at the participant’s home. If face-to-face Sample size calculation is based on the results of previ- follow-up is not possible, a telephone assessment can be ous RCTs assessing the effect of geriatric rehabilitation conducted. In all cases, assessment will include at least on improvement of the FIM. Accordingly, it is expected the telephone version of: Barthel, Rankin, Lawton, FIM, that geriatric rehabilitation will induce a 20 points im- FAC, GSE, DUKE-UNK-11, GDS-15, EQ-5D. provement in FIM between admission and discharge [47]. This change has been established as “minimal clin- ically meaningful” improvement [48]. It is expected that Process evaluation MI plus geriatric rehabilitation will result in a “moder- Since MI intervention is a complex intervention, as ob- ately relevant” clinical improvement in FIM, estimated served in Fig. 1 (logic model), the trial includes a process to be 30 points. That is, MI will induce an additional evaluation to enhance the interpretation of the results of improvement of 10 points (which corresponds to ap- effectiveness. This is based on the Medical Research proximately 10% of total FIM score), compared to the Council (MRC) guidance [45, 46], and focuses on how control group. Considering a common standard devi- the context, implementation and impact mechanisms ation of 27.9 points in FIM, a 10% of drop-out rate might influence each other and shape outcomes. Specif- at 30 days, and accepting an alfa risk of 0.05 and a ically, we will assess: 1) the quantity and quality of what beta risk of 0.2 in a bilateral contrast, we would need is delivered (implementation); 2) the generalizability of to include 136 stroke survivors in each branch (total the effectiveness by understanding the role of context sample = 272) to detect this improvement as statisti- and the comparability between intervention sites; 3) the cally significant. Calculations were obtained using the mechanisms of impact; and 4) perceived impacts and ad- GRANMO program [49]. verse events. Descriptive statistics will be presented for the overall Each assessment will be addressed complementarily by characteristics of the study sample (intervention and quantitative and qualitative methodological procedures. control group) as frequencies and percentages for nom- Observation checklists and attendance registry will be inal or categorical variables and means and standard de- conducted after each MI session by the interviewer. viations for continuous ones. Baseline comparisons These procedures will collect information on fidelity between treatment groups will be assessed as t-tests and (achievement of goals and tasks of each session), dose chi-square tests, to check for potential imbalances in and adverse events. Standardized scales (i.e. self- group composition and characteristics. efficacy) will be included in the baseline, post- The effect of MI in the change in total FIM score be- intervention and follow-up assessments to explore tween baseline and follow up (30 days) will be explored mechanisms of impact according to the logic model. through a longitudinal repeated-measures mixed effects Contextual characteristics will be collected in a semi- linear model, with the total FIM score as dependent structured questionnaire to capture shared and spe- variable, and a 2-level fixed factor accounting for the cific features of each intervention site. treatment group (MI or control). The model will adjust Complementarily, a qualitative evaluation will be for clinically relevant covariates, such as age, gender and used to explore participant experiences with the im- the amount of physical activity. plementation of the intervention, their personal and Group analyses will be carried out on an intention-to- social context, the mechanisms of impact and their treat principle. Missing data will be replaced by multiple perceived effects as well as unexpected events. It will imputations, after conducting explorations of the pos- consist in in-depth interviews at 30 days and at 3 sible missingness mechanisms. months on a purposeful sample of participants, se- Cost-utility analysis will be also performed to compare lected to maximize variability by gender, disability the benefit and costs of a MI programs. Cost-utility will levels, socio-economic levels, and social support. In be measured as the ratio between direct costs (workforce addition, a purposeful sample of caregivers and pro- time use to deliver the MI intervention and the related fessionals who performed the intervention will be also training and supervision, supplementary tests, use of interviewed. Finally, a focus group with reference re- other hospital resources, medical visits, readmissions, habilitation professionals of the units will be con- treatments, ambulatory rehabilitation, etc.) during ducted in each intervention site. hospitalization and also post-discharge (at 3 months) The process evaluation will be done by a MD and a and Quality Adjusted Life Years (QALYs). QALYs will social worker with great experience in qualitative ana- be derived using the EQoL-5D before and after the treat- lysis, designing complex evaluations and process evalu- ment and at 3 months. Therefore, cost-utility will be ation. These professionals will not have another role in calculated as the incremental ratio in € for 1 QALYs in this project. The results will be reported at completion. the intervention vs. control group [50, 51]. Gual et al. BMC Geriatrics (2020) 20:321 Page 9 of 12 All analyses will be carried out in Stata 15 (StataCorp. Recommendations for Interventional Trials (SPIRIT) 2017. Stata Statistical Software: Release 15. College Sta- checklist [52, 53], and the Template for intervention de- tion, TX: StataCorp LLC). scription and replication (TIDieR) checklist [54] are both provided as additional files 1 and 2. Legal and ethical aspects The protocol and the template informed consent forms Results has been approved by the Ethics Committee on Animal Final results are expected by end of 2020. See flow chart and Human Research (CEEAH) of the Universitat (Fig. 3). Autònoma de Barcelona (reference number CEEAH 3715). The rest of the participating centers’ Ethics Com- Discussion mittees ratified these premises. At the beginning of the This project is expected to provide new evidence on the project, an advisory board will be created including impact of MI on older stroke survivors, increasing the stroke survivors’ and caregivers’ representatives (from understanding on the implementation of a non- dedicated Associations or from the participating institu- pharmacological intervention based on a person- tions), health and social care professionals and centered approach, and assessing its impacts on policymakers, which will meet periodically with the re- objective outcomes. The project will be performed from search team. The commission of this board will be to: 1) a “triple aim” viewpoint (healthcare, efficiency and support and give feedback about the refinement of the person-centered outcomes and experiences), through study and intervention design; 2) promote constant feed- multi quantitative and qualitative methods. Accordingly, back on project progress and help to overcome potential the IMAGINE study will develop a new area of research barriers; 3) foster communication, dissemination and with an innovative approach: empowering older stroke knowledge translation. survivors that are in vulnerable conditions, and building Prior to any assessment and intervention, all partici- their rehabilitation process with them rather than only pants in the study granted written and verbal informed for them. Thus, it changes the person’s perspective from consent. his/her limitations to his/her strengths. In the same line, All study-related information will be stored securely at this study focuses on a novel approach by fostering re- the reference center Server. All participant information sidual capacities based on personal goals instead of will be stored in locked file cabinets in areas with limited “treating disability”, in line with novel frameworks [10, access. All reports, data collection, process, and adminis- 55]. The MI approach can easily be part of professional trative forms will be identified by a coded ID number training or configure novel specialty training for health- only to maintain participant confidentiality. All records care professionals involved in rehabilitation services, that contain names or other personal identifiers, such as providing a unique opportunity of scaling up the inter- informed consent forms, will be stored separately from vention. The focus on person centered care is expected study records identified by code number. All local data- to increase person satisfaction, which will be assessed by bases will be secured with password-protected access exploring the experiences of the stroke survivors and systems. Forms, lists, logbooks, appointment books, and professionals involved. In addition, the trial is based on any other listings that link participant ID numbers to objective outcomes that are relevant for older stroke sur- other identifying information will be stored in a separate, vivors, since mobility and physical function limitations locked file in an area with limited access. are a major barrier for quality of life. We will also assess The coordinator of each intervention site will be given other aspects such as well-being or self-efficacy, as a access to the cleaned data sets, housed on the file trans- health resource with major influence on quality of life fer protocol site created for the study, and all data sets and with potential to explain the mechanisms of impact will be password protected. Project Principal Investiga- of the MI intervention. tors will have direct access to their own site’s data sets, Regarding stroke survivors, MI has been used mainly and will have access to other sites data by request. To in chronic stages in order to promote and maintain ensure confidentiality, data shared with project team pharmacological treatment and lifestyle changes [32, 56, members will be completely anonymized without any 57]. Recently, two research groups have described a pos- identifying participant information. sible association between the early use of MI, functional The feasibility and scientific quality of the trial has and mood improvement and a reduction of mortality been peer-reviewed and approved by the Principal Inves- [58, 59]. However, as none of these studies focused on tigators and Research and Development team. The trial older adults, the evidence of its use during the subacute protocol will permit its reporting in line with the phase of stroke in older adults is scarce [60]. Similarly, Consolidated Standards of Reporting Trials (CONSORT) English et al. [32] assessed the feasibility of MI in a small guidelines [26]. The Standard Protocol Items: sample (N = 35) of stroke survivors (> 6 months) in the Gual et al. BMC Geriatrics (2020) 20:321 Page 10 of 12 Fig. 3 Flow chart community. They also assessed the impact on physical recruitment capability. Moreover, our previous MI pilot activity, as the reduction of sitting time measured using [27] showed high acceptance of the intervention, which accelerometers. The intervention was found feasible and should reduce the risk of dropouts. Although in a non- safe but the observed sitting time reduction was not pharmacologic trial it is almost impossible to blind par- significantly different from the control group. Recent stud- ticipants and professionals delivering the intervention, ies on frail older adults with mobility limitations from the procedures have been set to guarantee as much as pos- community have confirmed safety and showed potential sible blinding outcome assessors. cost-effectiveness of a rehabilitative person-centered ap- This project has the potential to directly change the de- proach [23]. These results are in line with other studies cision making process in the rehabilitation of older stroke that suggest cost-effectiveness [23, 61], and cost-utility survivors. As almost half of stroke survivor’s experience [62, 63] of MI used to promote changes in lifestyle, in dif- relevant residual disability, with stroke being the main ferent settings and populations. However, such studies cause of disability in Western countries [2], new rehabili- have not been carried out with stroke survivors. tation and recovery strategies are needed and will have a Potential critical aspects and risks might be an insuffi- high impact for the society. Likewise, the knowledge cient sample size or important attrition; although in case gained by this project, including the intervention and its of need, other geriatric rehabilitation centers of the effects also in terms of costs, should inform current health Catalan healthcare network (Catsalut) could be included. care policies at national and international level on how to Strengths of the study are the three intervention sites, enhance established rehabilitation programs with an referent centers for geriatric stroke rehabilitation in empowering approach, thus taking a major profit of cur- Catalonia, who have also previously shown their rently limited economic and human resources. Gual et al. BMC Geriatrics (2020) 20:321 Page 11 of 12 Supplementary information Spain. 3Psychiatry Department, University Hospital Vall d’Hebron, Barcelona, Supplementary information accompanies this paper at https://doi.org/10. Spain. 4Fundació Salut i Envelliment (Foundation on Health and Ageing), 1186/s12877-020-01694-6. Universitat Autònoma de Barcelona, Barcelona, Spain. 5Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain. 6University Hospital Santa Maria, Lleida, Spain. 7Hospital General de l’Hospitalet (Consorci Sanitari Integral), Additional file 1. Hospitalet de Llobregat, Spain. 8Department of Health Sciences, Lund Additional file 2. University, Lund, Sweden. 9Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund-Malmö, Sweden. Abbreviations Received: 9 April 2020 Accepted: 10 August 2020 FIM: Functional Independence Measure; ICF: International Classification of Functioning, Disability and Health; MI: Motivational interviewing; MITI: Motivational Interviewing Treatment Integrity Code; m-RS: Modified- Rankin Scale; NIHSS: National Institute of Health Stroke Severity; QALY: Quality Adjusted Life Years References 1. 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