A multi-domain group-based intervention to promote physical activity, healthy nutrition, and psychological wellbeing in frail older people: 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 more effective approach to enhance IC and to prevent frailty and dependence, being adapted physical activity is the preventive intervention that has shown more evidence in the treatment of frailty and risk of falls. The present study aims to describe the development of a multi-domain group-based intervention addressed to frail older people living in the community aimed to improve and/or maintain intrinsic capacity by means of promoting physical activity, healthy nutrition, and psychological wellbeing in frail older people. We used the GUIDED checklist to describe the development process of AMICOPE (Aptitude Multi-domain group-based intervention to improve and/or maintain IC in frail Older PEople). The intervention was built upon the ICOPE framework and it is described with Template for Intervention Description and Replication (TIDieR) guidelines and it includes dietary advice, cognitive stimulation strategies, medication review, goal setting, and activities to strengthen social support and manage depressive symptoms, as well as strength, balance and flexibility exercise using the Vivifrail program. The 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 in a later stage, assessing the effectiveness in a randomized controlled

advise on the adequate amount of these foods [39]. Concerning the psychological domain, literature shows how several structured approaches and therapies, such as Cognitive Behavioural Therapy (CBT), problem-solving, behavioural activation and life review, are susceptible to be modified into brief interventions to address depressive symptoms [40]. Regarding this latter, another critical issue to be considered is strengthening social support and staying socially connected to tackle loneliness and social isolation [41] as well as providing a list of local community services available to older people and encourage their use to increase their participation in identifying potential barriers to community engagement [13].
Thus, there is a need to develop and assess community-based interventions to enhance intrinsic capacity and prevent frailty and dependence. Among them, and based on available evidence, multi-component interventions appear to be more effective [11]. The purpose of this article is to describe the development of a multi-domain group-based intervention addressed to frail older people living in the community aimed to improve and/or maintain intrinsic capacity by means of promoting physical activity, healthy nutrition, and psychological wellbeing in frail older people.

Materials and Methods
In this study we use the "Guidance for reporting intervention development studies in health research" (GUIDED) checklist [42] to detail the development process of AMICOPE intervention. The text below describes the process of intervention development in relation to the 14 items of the GUIDED checklist. The intervention was developed in the context of two different projects. On the one hand, the APTITUDE project [43], and on the other, the model for the prevention of disability and the promotion of personal autonomy in Catalonia [44]. APTITUDE is a European project funded by POCTEFA 2014-2020, which is the acronym of the INTERREG V-A Spain-France-Andorra Program. The APTITUDE project involves 11 different territories from Occitania, Andorra, Navarra, and Catalonia in the cross-border area of the Pyrenees. The general objective of APTITUDE is to prevent the dependency on older people by creating a network to promote care, training, research, and innovation in the areas of public health and gerontology. The network was structured with local coordination referents (n=10-15) and operational teams (n=50-100) in each territory. The model for the prevention of disability and the promotion of personal autonomy is a joint initiative of the Department of Health and the Department of Labor, Social Affairs and Families of the Catalan Government. This project has already started in five pilot territories and should be progressively implemented over the next years throughout Catalonia.
The target population of AMICOPE corresponds to frail older people living in the community with losses in mobility, nutritional and/or psychological domains of intrinsic capacity, and without cognitive decline, visual impairment or hearing loss. Our appraisal was theory and evidence-based, as well as coherent with the framework of the Medical Research Council (MRC) for the development and evaluation of complex interventions [45]. This framework is appropriate to be applied for those interventions including a number of components interacting one with each other, several recipients and outcomes, different skills needed by the facilitators and certain level of tailoring. During the intervention development process, decisions were taken in accordance with evidence from resembling interventions delivered to frail older people, and results from our previous studies. We also integrated the recommendations of a working group, the appropriateness of different frameworks used in implementation research, and evidence shown by few strategies which seemed to be effective. Figure 1 illustrates how evidence from different sources enlightened the intervention development process of AMICOPE intervention. The theoretical rationale driving the design and the development of this multidomain intervention was the ICOPE program of the WHO [11]. Rather than creating an entirely new intervention, AMICOPE was developed by incorporating components adopted from already existing interventions that have shown evidence in increasing functional capacity and improving mental health in older people. Hence, the Vivifrail program [46] was used for the domain of physical activity, and some methodologies used in the "Feeling Well" program [47] (e.g. mapping party, photo-ellicitation, goal setting) were applied for the domain of psychological wellbeing and to promote behaviour change. An intervention guide for the facilitators set up a frame to lead group activities adhering to general basic rules detailed in a decalogue and a common structure whilst taking into account participants' preferences, needs and expectations.
A working group including members appointed by the Department of Health and the Department of Labor, Social Affairs and Families, and members of the APTITUDE network, reviewed the general scope of the intervention in a first stage of the process development and contributed to defining some critical aspects of each component. This working group included health and social care professionals, members of local administrations, community representatives and entrepreneurs of the silver economy, among other stakeholders. Evolving versions of the intervention were presented during the development process to integrate stakeholder contributions. Due to the iterative and complex nature of the intervention development process, some changes affected the scope of the intervention. Hence, and even though it was beyond the intervention's initial aims, specific contents about cognitive stimulation and medication review were suggested by the working group and finally incorporated as part of the intervention that was defined at the end of the development process. The intervention also considered different types of physical activity according to the frailty level of participants. At the end of the development process, some uncertainties remained mainly related to the implementation of the intervention in isolated, sparsely, and low-density rural areas of the Pyrenees, and the impact of the COVID-19 pandemic in the realization of group-based activities with older people. The current publication is open access and materials of AMICOPE multidomain intervention are available on demand.

Results
The result of the study is a group-based multi-domain complex intervention described according to the TIDieR (Template for intervention description and replication) guidelines [48]. The intervention is called "AMICOPE" (Aptitude Multi-domain intervention to promote Intrinsic Capacity in Older PEople), and it is aimed at promoting physical activity, healthy nutrition and psychological wellbeing in frail older people living in the community. The guiding principle of our work was the ICOPE strategy [11] and the conceptual framework of the intervention is described in fig. 2. The materials to be used in the intervention include a detailed guide for the facilitators, Vivifrail physical exercise program resources (passports, App and videos), and working sheets, maps, photographs, and audio files to perform some other activities. The intervention procedures for physical activity were based on strength, balance, flexibility and aerobic exercises. Several group dynamics were designed to promote social support and exchange of personal experiences among participants, as well as the acquisition of self-management skills. Goal setting will be used to promote behavioural changes in the daily life of participants that are meaningful for them and that positively affect their healthy nutrition and psychological wellbeing. A pair of health and social care professionals with different background (nurse, physiotherapist, occupational therapist, nutritionist, psychologist, physical activity trainer, etc.) will be previously trained as group facilitators by the research team, during a 30-hour training program based on how to apply the intervention guide.
The intervention consists of 12 face-to-face sessions and facilitated in groups of 8 to-12 frail older people. Sessions are held weekly for 2.5 hours during three months. Each session includes one hour of physical exercise using the Vivifrail program, and 1.5 hours dedicated to any other intervention components. The intervention will be delivered in community facilities such as senior leisure centers, civic centers, or primary care centers, and in different locations of the surroundings. Particularly, 10 of the 12 sessions will take place in a space large enough to do physical activity. For one session the whole group will move to a food store or supermarket to learn about nutritional facts. The remaining session will be devoted to visit another senior center with the purpose to know about programs and activities addressed to the community.
The physical activity domain of AMICOPE includes individual prescription passports for participants tailored to their individual functional capacity, which will be assessed by the Short Physical Performance Battery (SPPB), a walking speed test, and the risk of falls. Nevertheless, other activities are intended to facilitate adherence to the intervention, enhance social cohesion and change lifestyles. Hence, participants bring to the group personal objects to introduce themselves and share SMART goals in accordance with their own preferences to increase self-efficacy. Finally, outings are chosen and agreed after a group mapping activity of local community assets, and this allows each intervention to be -beyond individual interests and preferences-slightly adapted to a specific context.
The intervention was planned to be piloted in Catalunya and ten health and social professionals (six nurses, two physiotherapists and two physical activity trainers) were trained during November and December of 2019. A pilot of AMICOPE intervention addressed to a group of 12 frail older people started in Tortosa (Baix Ebre/Spain) in the beginning of February 2020 but had to be dramatically cancelled after six sessions due to the outbreak of the COVID-19 pandemic in Spain. A feasibility study will be conducted in the territories of the APTITUDE project to pilot the intervention, to incorporate any modifications that may improve the design, procedures, or implementation. For that purpose, one or two health or social care professionals will monitor the intervention to fill an observation log that includes several quantitative and qualitative indicators of implementation such as fidelity and adherence.

Discussion
In this study we use the GUIDED checklist to describe the intervention development process for the AMICOPE group-based multi-domain intervention. We rationalize the process by detailing: the context, the aim, the recipients, the theory and evidence-base, the utilization of previous experiences, the guiding principles, the participation of stakeholders, the changes made throughout the process, and remaining uncertainties. The intervention itself is described using the TIDieR checklist and reporting of the intervention development process draws on frameworks such as the WHO Integrated Care of Older People and the UK Medical Research Council framework to develop and evaluate complex interventions.
The AMICOPE intervention is addressed to frail older people living in the community and aims to improve and/or maintain IC by promoting physical activity, healthy nutrition, and psychological well-being in frail older people. A multimodal exercise program tailored to individual capacities and needs has been suggested as the most important approach to improve or maintain locomotor capacity [11,[16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. The significant contribution of nutrition to frailty has also been underlined by some authors [35,37]. However, other researchers have suggested that nutritional interventions delivered alone may not be effective for the management of frailty on older people [49]. As for the psychological domain, previous studies showed that group-based interventions addressing loneliness and social isolation could help to reduce depressive symptoms [41,50]. During the development process, specific and brief contents about cognitive stimulation and medication review were finally incorporated as part of the intervention, though it was beyond the initial aims of the intervention. This decision was taken on the basis that preventive cognitive training has benefits for older people, as reported by researchers [51]. Medication review can reduce polypharmacy by eliminating unnecessary, ineffective and medications with a duplicative effect [52]. Nevertheless, scientific literature has evidenced that most factors related to losses in intrinsic capacity share the same underpinning physiological and behavioural causes [11]. Hence, interventions have benefits across different domains of IC. Physical exercise prevents loss of mobility but also has indirect preventive effects against depression and cognitive decline [16]. Nutrition reinforces the effects of exercise [35][36][37]. Loneliness increases the risk of malnutrition [53]. Finally, we included goal setting as a cross-sectional element in our intervention, which has been considered by some authors as an effective behavior change technique as well as a fundamental component of successful interventions [54], including those promoting dietary and physical activity [55] and particularly when integrated in complex interventions addressed to older people [56].

Strenghts and limitations
To our knowledge, AMICOPE is the first group-based complex intervention aimed to improve some components of intrinsic capacity in older people, that it is built upon the ICOPE framework. Although the intervention proposed in this study covers most of the IC components, we were not able to incorporate any components addressing visual deficiency and hearing loss, both related to the sensorial domain.
The use of the GUIDED checklist provides a detailed information about the intervention development process and allow researchers to understand important aspects when developing multi-domain intervention addressing frailty and/or losses in IC. We hope this will help the scale-up, replication, adaptation, or more comprehensive implementation of AMICOPE in other settings. We also think that the approach described in this study can be used as a model for future research in the development of complex interventions. Scientific literature is scarce for published intervention development studies. To date, the few examples found using the GUIDED checklist includes two PubMed peer-reviewed articles reporting interventions aimed to improve mental health help-seeking behaviours for male students [57], and tamoxifen adherence in breast cancer [58]; two preprints reporting interventions aimed to improve early diagnosis of cancer in primary care [59] and targeting antipsychotic prescribing to nursing home residents with dementia [60]; and one doctoral thesis reporting an arts-based intervention for patients with kidney disease [61].
Another significant limitation is that the initial pilot of AMICOPE was cancelled after having completed only half of the intervention, due to the outbreak of the COVID-19 pandemic. This paper reports an intervention development study as 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 in a later stage, assessing the effectiveness in a randomized controlled trial.

Conclusions
This paper describes the development process of AMICOPE, a group-based multidomain complex intervention built upon the ICOPE framework and aimed to improve and/or maintain IC through the promotion of physical activity, healthy nutrition, and psychological wellbeing in frail older people. The study is reported according to the GUIDED checklist and 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 in a later stage, assessing the effectiveness in a randomized controlled trial. Funding: This research was funded by the program POCTEFA (European Union) in the context of the APTITUDE project, reference EFA232/16.