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Abstract
Introduction Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.
Methods and analysis This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.
Ethics and dissemination This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.
Trial registration number NCT05639478.
- Diabetic foot
- Primary Health Care
- Diabetic neuropathy
- Physical Therapy Modalities
- Foot & ankle
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Strengths and limitations of this study
This study protocol describes in depth the steps of conduct for a hybrid type 2 implementation-effectiveness study in a municipality in the State of São Paulo, aiming to test and to implement a preventive foot-ankle exercises programme to modify the risk factors for diabetic foot in a primary healthcare setting.
One of the strengths of this protocol is the inclusion of all four phases foreseen in implementation science studies, using a mixed-methods approach.
In the first phase, preimplementation, we will gather the perceptions from different stakeholders about the preventive programme, the facilitators of and the barriers to the implementation, and the changes and adaptations to the preventive intervention necessary to increase its scalability.
Regarding the limiting challenges, political issues greatly influence how the project phases will flow, thus a viable and effective partnership between the university and the municipal management should be established for a successful implementation.
An additional challenge will be to motivate health workers in public services to adhere to this innovative project, especially in a postpandemic period, when they frequently face large workloads with limited resources and infrastructure.
Introduction
The 5 year mortality of people with diabetes and foot ulcers is three times higher than the mortality from breast cancer.1 In addition, diabetes has an intense impact on quality of life outcomes, being the fourth most common cause of disability in the world.2 According to Diabetes in America,3 40% of women and 25% of men with diabetes reported severe mobility impairments, and one in three people need or will need rehabilitation at some point in their lives. This has led to a 63% increase in the need for rehabilitation in primary healthcare settings for the last 30 years.2 In Brazil, this context is a challenge even for the Sistema Único de Saúde (SUS, translation: Brazilian Unified Health System), which guarantees comprehensive and universal care.
This scenario is associated with the fact that diabetes culminates in the development of diabetic peripheral neuropathy (DPN), which is characterised by protective foot sensation loss; vascular alterations;4 and neural,5 6 musculoskeletal,7 8 and biomechanical9 impairments. These impairments lead to significant changes in the foot rollover mechanics during gait, which in turn results in plantar pressure distribution alterations10 favouring the appearance of plantar ulcers and the eventual need for amputation.11 Many of the foot and lower limb musculoskeletal deficits that result from diabetes and DPN, such as deformity, muscle weakness, decreased distal range of motion (ROM), rigidity of connective tissue, poor balance, and coordination issues, are either preventable or can potentially be restored by specific interventions.12 Recently, and for the first time in more than 20 years, the International Working Group on the Diabetic Foot (IWGDF) recommended in its guideline chapter about prevention of diabetic foot,13 foot-ankle mobility and strengthening exercises as a strategy to prevent modifiable risk factors for ulceration. There is scientific evidence supporting that these exercises decrease peak pressure during gait, increase foot-ankle ROM, improve DPN signs and symptoms, and increase foot muscle strength and functionality, which constitutes the main risk factor for ulcers in this population. Implementation of this recommendation strategy is generally feasible in different SUS health settings, including primary care units; is accepted by people with diabetes; and could potentially increase equity.
It is widely recognised that ulcers and amputations are a very serious issue in healthcare systems worldwide, and for every euro spent on prevention, 10 are spent on ulcer management.14 This scenario is no different in Brazil, as the problems related to long-term diabetes complications can undermine the prevention strategies adopted by the SUS. While there are strong and highly disseminated public health policies for cancer prevention, especially for breast cancer,15 foot ulcers have not yet had their own public health policies established, nor have specific prevention campaigns been adequately executed. Preventive interventions in the context of primary healthcare to reduce risk factors on a large scale and at a low cost are much needed, especially in developing countries such as Brazil, to minimise the burden caused by diabetes and DPN.
Given the context presented, this study is based on implementation science with the goal of incorporating this programme in the Brazilian Ministry of Health16 care line for adults with type 2 diabetes. The aim of this contextually appropriate intervention strategy in primary care is the prevention of modifiable risk factors for ulcers in people with diabetes. A foot-ankle exercise programme will be implemented alongside educational strategies for foot care in the city of Limeira/SP. The study will follow Meyers et al’s17 structural rationale for implementation studies: preimplementation phases, an implementation phase and the maintenance phase. We will monitor the implementation’s outcomes and the effectiveness of the preventive intervention for improving functionality and quality of life in people with diabetes.
Methods and analysis
Overview of the study design
This is a hybrid type 2 implementation-effectiveness study18 with the objective of investigating the implementation results and clinical outcomes of an intervention based on the practice of foot-ankle exercises in addition to educational actions in primary care units in the municipality of Limeira/SP. Reporting will be based on the Standards for Reporting Implementations studies (StaRI).19 The study protocol is described following all recommendations established by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) (2022).20
Phases
The study will take place in four phases (figure 1) following Meyers et al’s17 structural rationale for implementation studies. Phase 1, preimplementation, is intended to gather information about the local context, detailing barriers, and facilitators through active listening to the different stakeholders (nurses, community health agents and members of the multidisciplinary team, comprised by physiotherapists, nutritionists, social assistant professionals, psychologist, and occupational therapists) involved. In this phase, we will conduct a needs and resources assessment, including an assessment of the stakeholder’s agreement to the implementation. We will formulate capacity-building strategies, obtain explicit buy-in from critical stakeholders, foster a supportive organisational climate, build organisational capacity, and conduct effective preinnovation staff training. To fulfil this aim, nurses, community health agents, and the multidisciplinary team (eMulti) will be invited to a brainstorming activity. In this activity, we will present a brief introduction about the diabetic foot and the technologies available for managing the long-term complications arising from diabetes and DPN, followed by a semistructured interview based on the five consolidated framework for implementation research (CFIR) domains. This phase is still ongoing, started in August 2023 and it is planned to be concluded in December 2023.
Flow chart of the four phases of the implementation study.
Phase 2 main aim is to create the implementation team and prepare the action plan for the implementation. The team will be defined based on the knowledge and expectations of the stakeholders that took part in the brainstorming activity and champion leaders, which are people who inspire and empower those around them to reach their full potential, leading by example and fostering a positive and productive work environment. Although originating from the initial group, this team will be more restricted in size and will be responsible for structuring the health professional training and the clinical intervention, adapting it to the context (barriers and facilitators) defined in phase 1. This group will also be responsible for devising strategies for implementing the foot-ankle preventive programme. This phase has not started yet, it is planned to start in January 2024 and will last 4 months.
There are two objectives for phase 3, the implementation phase. The first is to train health professionals (nurses, community health agents, physicians and members of the multidisciplinary team) regarding the disease and its chronic complications, and the second is to test the effectiveness and to implement the intervention focused on self-care and foot-ankle exercises through educational groups. The professional training will include meetings and workshops with experts on topics related to the disease and to foot-ankle exercises, and a case study of clinical inertia will be proposed. This case study will be inspired by a scenario where a failure of health services occurred to initiate or modify treatment when necessary,21 and how amputation can be avoided. The aim of this case study is to increase the health professionals’ awareness of the topic and to align their personal values and perceptions with the importance of changing this scenario related to the diabetic foot. The content and structure of the meetings will be established by the implementation team. The professional training will start in May 2024 and will last 5 months.
As for the second objective of this phase, the effectiveness of the intervention will be tested by a cluster randomised controlled trial and the therapeutic programme will be detailed in further items in this paper. This phase has not started yet, it is planned to start in October 2024 and will last 12 months. The recruitment for this stage is yet to begin at the time of protocol submission.
Finally, in phase 4, the maintenance phase, the aim will be to support the continuity of the project in the municipality, as well as the dissemination of results to other levels of care in Limeira and to other municipalities in the state of São Paulo. This phase has not started yet, it is planned to start in October 2025 and will last for 4 months.
Study setting
The study will be carried out in Limeira, a medium-sized city in the countryside of São Paulo, located 150 km from the capital. The municipality, with an estimated population of 291 869 inhabitants in 2022, is similar to many Brazilian municipalities, where more than 50% of the population depends exclusively on SUS services. A cooperation agreement was set between the university and the municipal health secretary. Limeira has 32 primary health units, however only 56% of them are covered by three eMulti teams that include physiotherapists, psychologists, social workers, occupational therapist, speech therapist, and nutritionists. Considering that the proposed intervention primarily depends on an integrated care delivered by a multidisciplinary team, our preferable scenario will include only these units covered by the eMulti teams. Each eMulti team is responsible for 6 units, totalling 18 potential clusters in the implementation-effectiveness cluster randomised controlled trial.
Study population
For phase 1, the population will include eMulti team members, nurses and community health agents from primary healthcare units in the municipality of Limeira. For phase 2, the implementation team will be comprised of stakeholders who participated in the brainstorm activity and accepted the invitation. For phase 3, the study population for the training stage will include the community health agents, nurses, physicians, and the eMulti team members. For the clinical intervention, participants will be adults of both sexes diagnosed with type 1 or 2 diabetes. For phase 4, the population will be the same as in phase 2 with the addition of municipal management, represented by the health secretary and the coordination of primary care and the eMulti teams.
Patient and public involvement
As expected in any implementation science study, the implementation team, workers of the healthcare units, management representatives and researchers will participate in the design, conducting, reporting and dissemination plans of our study. In addition, following the contemporary trend of a patient partnership strategy, we intend to include people with diabetes that are employed in the municipal health secretary, particularly in phases 1 and 2, when they will discuss the methods of the implementation of the intervention and plans for dissemination of the results.
Effectiveness cluster randomised trial design
The FOot CAre and exercises ImplementatioN for people with diabetes in primary care trial (FOCAIN trial) is a cluster randomised controlled, superiority, single-blinded trial that was prospectively registered at ClinicalTrials.gov (FOot CAre and Exercises ImplementatioN for People with Diabetes in Primary Care (FOCAIN)’, in 25 November 2022 (figure 2). This trial will have an allocation ratio of 1:1 and will follow all Consolidated Standards of Reporting Trials (CONSORT) recommendations.22
Flowchart of the steps for the development of the cluster randomised controlled clinical trial.
Participants and recruitment
Participants for the randomised cluster trial will be recruited from the 18 primary care units covered by eMulti team in Limeira. The inclusion criteria will be adults of both sexes diagnosed with type 1 or 2 diabetes who are from the area covered by the eMulti teams, able to walk independently for at least 10 m, literate and available to participate in the intervention at the established group time. The non-inclusion criteria will be illiterate patients, those with clinical dementia (either described in the patient’s clinical record or indicated by a cognitive inability to answer the questionnaires), who have severe visual and/or hearing impairment, who are unable to give consistent information, who receive any other physical therapy intervention during the entire intervention period, or who have an active foot ulcer or major vascular complications. Participants will sign an informed consent form approved by the ethics committee (online supplemental material 1).
Supplemental material
Randomisation, allocation, and blinding
Primary care units covered by eMulti teams (18 clusters) will be randomly allocated to receive (intervention group, IG) or not receive (control group, CG) the intervention programme in a 1:1 ratio. The randomisation schedule will be prepared using Clinstat software (University of York, UK) by an independent researcher who will not be aware of the numeric code for the CG and IG clusters. The numerical sequence of the clusters to be included will be kept in opaque envelopes, numbered sequentially, following an order generated by the software. This sequence will be kept private and stored in a location where blind assessors do not have access. Only the main researcher will know the meaning of the codes. After agreeing to participate in the study and signing the Informed Consent Form (online supplemental material 1), allocation of the primary care unit (cluster) to the groups will be made by an independent researcher who will not know the numeric codes identifying the groups. All individuals with diabetes from the selected care units (clusters) will be allocated to either the CG or IG.
All personal data will be kept confidential before, during, and after the study by coding the participant’s name. All outcomes’ assessors will be blinded to group codes. Due to the nature of the study (intervention based on foot exercises), it is not possible to blind the health professionals responsible for delivering the intervention. In addition, the participants cannot also be blinded to the exercise intervention; however, participants will not be aware of the study hypotheses. The trial statistician will also be blind to treatment allocation until the main analysis is accomplished.
Sample size calculation
The population-based sample took into account the total inhabitants catered by the three eMulti teams. Each team is responsible for six primary health units, each one covers an average of 5000 individuals; thus the 18 clusters comprise 90 000 potential individuals. Considering that we will include only literate adults, 24.2% of the Limeira population is under 18 years old, and 6.6% of adults are illiterate, the target population is 63 718 individuals. In addition, the Brazilian prevalence of diabetes is 7.4%,23 therefore, we can estimate a total of 4715 people with diabetes in Limeira that can be considered our study population.
The sample size was based on the finite population sample calculation (equation 1), which takes into account the population size (n=4715), margin of error (5%), and SD (50%), resulting in a sample of 356 people, 178 in the CG, and 177 in the IG. For sample selection, a stratified systematic sampling procedure will be used with proportional sharing by age in years and time since diagnosis in months.
(1)
where n=population = 4.715; Z=Z score = 95%; e=margin of error=5%; p=SD=50%
In addition, we checked if the sample size calculated would be enough to detect between-groups differences. For this additional calculus, we adopted a small effect size (0.15) for the primary outcome—DPN symptoms, according to results of previous trials published,24 a statistical power of 0.80 and a alpha value of 0.05. The sample size resulted in 262 individuals, which is lesser than that we calculated based on the population. Thus, the sample size of 356 would be completely adequate to detect between-group differences in the trial.
Treatment arms
CG participants will not receive any specific intervention besides standard recommendations and standard care,13 including medical and pharmacological treatments delivered by the health teams from the primary healthcare units. In addition, they will receive the foot care recommendations based on the IWGDF guidelines13 (table 1), printed on a flyer and explained at an orientation session by the main researcher before the commencement of the study. IG participants will receive foot care recommendations from the IWGDF in addition to a 12 week supervised foot-ankle exercises programme by a health professional using a group-based approach. The session duration, frequency, and format will be determined by the implementation team. Participants from both groups will be assessed at baseline and 12 weeks (end of intervention).
Foot care recommendations for prevention of foot ulcers in people with diabetes based on the International Guidelines from the International Working Group on Diabetic Foot
Intervention
The structure and format of the supervised foot-ankle exercises programme (session duration, frequency, number of participants, etc) will be defined by the implementation team in phase 2, based on the local context, barriers and facilitators analysed in phase 1. The programme will start after the health professionals are trained in phase 3. The 12 week intervention programme, in addition to educational actions, will be based on a group-based approach either using the Sistema de Orientação ao Pé diabético (SOPeD; translation: Diabetic Foot Guidance System) and/or a booklet containing the foot-ankle exercise programme. In addition to the supervised sessions, participants will be encouraged to perform the exercise programme at home with guidance from the booklet or SOPeD.
SoPeD is a software that customises a foot-ankle exercise programme for people with diabetes based on their individual health and fitness conditions. In addition, it makes it possible to perform specific foot-ankle exercises focusing on musculoskeletal deficits arising from diabetes and DPN. The software supports self-care and self-assessment in order to promote foot health. Patented by the National Institute of Industrial Property (BR512019002532-6), the software is public, free, and accessible via a browser (www.soped.com.br) or mobile application (Android system).25 The comprehensive therapeutic exercise protocol is detailed elsewhere,25 but in summary, the SOPeD includes a total of 104 functional, stretching, and strengthening exercises of the extrinsic and intrinsic foot muscles. The progression for each exercise in intensity and complexity was customised based on the individual’s perceived effort as determined by an algorithm. The SOPeD includes gamification components to increase adherence and encourage users to continue exercising.
The educational booklet contains a customised foot-ankle exercise programme with six specific strengthening exercises for the intrinsic foot muscles (four exercises) and the extrinsic foot-ankle muscles (two exercises), in addition to recommendations on foot care and information on diabetes and DPN. Each exercise comes with a description explaining how it should be performed and illustrative photos. The selection of the six foot exercises and the inclusion of progression parameters are based on results from previous clinical studies.26 The exercises will be performed in the order suggested by the booklet using objects such as cotton, pencil, balls and chairs. The foot exercises will first be performed in the sitting position in one set with 12 repetitions. If the patient finds this too easy, the exercise will then be performed in the standing position and then standing on one foot. The patient can also increase the number of sets. Patients will follow the exercise programme from the booklet with instructions for each exercise prescribed, and after each task, they will fill out a table stating the perceived effort for each exercise (using a Likert scale).
To promote long-term participation, each session will be conducted in groups. Adherence to the intervention will be evaluated through face-to-face sessions with the health professionals responsible. Telephone calls will be performed if a participant misses two consecutive sessions.
The discontinuation criteria for the foot-ankle exercises during any session include cramps, moderate to intense pain, fatigue, dizziness, fear or any other condition that exposes the patient to any discomfort. The other discontinuation criterion for the intervention is the occurrence of foot preulcerative signs (blisters and calluses) or foot ulcers as assessed by a blinded podiatrist nurse specialising in diabetic feet. All adverse events occurring during the trial period will be recorded. Minor adverse effects potentially expected are sore muscles and tiredness after performing the proposed exercises. Participants in both groups will be advised to avoid other concomitant types of care such as physical therapy, acupuncture, or unconventional medical treatment during the study. In cases where treatment is indispensable, the patient must advise the investigators.
Study outcomes, timeline, and data analysis
Considering the fact that our study design is a type 2 hybrid,18 we will monitor and analyse both outcomes from the implementation and the clinical intervention through a mixed-methods approach.27 The CFIR framework28 and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework (RE-AIM)29 will guide the collection and analysis of both quantitative and qualitative data, in addition to the clinical, functional, and quality of life outcomes resulted from the intervention. All outcomes will be assessed at baseline (before the intervention) and after 12 weeks of clinical intervention by the same experienced evaluator, who will be blinded to the allocation.
Implementation outcomes and data analysis
For the preimplementation phase (phase 1), qualitative data will be collected during the brainstorming activity using the rapid analysis for the CFIR framework, specifically for analysis in implementation sciences.30 These data will be recorded, analysed, and coded immediately after the activity, based on the five CFIR domains. A second assessor will review the coding via audio recordings and edit the notes. Weekly meetings will be scheduled between the assessors for necessary amendments in the analysis. On consensus, the impact of the constructs on the implementation will be classified as positive or negative, and, later, as weak or strong. The adoption of the brainstorming activity will be measured by the number of actors participating in the activity divided by the total number of invited actors, expressed as a percentage. The representativeness of actors and locations will also be analysed.
In phase 2, adoption will be calculated by the percentage of actors participating in the implementation team divided by the total number of actors enrolled. The representativeness of actors and locations will also be analysed qualitatively.
The reach and implementation will also be analysed using the RE-AIM framework during the implementation phase (phase 3). The reach, calculated at an individual level for both professional training and for the educational groups of people with diabetes, will be obtained by dividing the population reached by the total population. Furthermore, the representativeness of the IG participants will be analysed based on sociodemographic and clinical data, compared with the CG. The implementation is defined as the fidelity to the initially proposed intervention and will include analysing the adaptations made in the course of the project’s implementation.
Effectiveness outcomes and data analysis
In the implementation phase (phase 3), to assess the effectiveness of the intervention, two primary outcomes will be analysed: DPN symptoms, measured using the Michigan Neuropathy Screening Instrument,31 and ankle and first metatarsal phalangeal joint ROM using manual goniometers.32 Secondary outcomes of the intervention will include the following: (1) DPN severity, measured by the Decision Support System for DPN Classification (Fuzzy software),33 which is available free of charge at http://www.usp.br/labimph/fuzzy/; (2) time up and go test,34 as a measure of functionality; (3) strength of the flexor muscles of the hallux measured by the enhanced paper grip test;35 (4) quality of life will be assessed using the EUROQOL (EQ-5D) instrument, which generates an index representing the value of an individual’s health status;36 and (6) the presence of ulcers or preulcerative lesions monitored by the outcome evaluator via photos sent by the physiotherapists responsible for the IG without identifying the participant.
Blind assessors will perform the baseline and follow-up assessments. Table 2 presents the primary and secondary outcomes and the study period in which they will be evaluated, according to SPIRIT guidelines.20
Schedule of enrolment, intervention, and assessments of the FOCAIN trial, following SPIRIT guidelines
We will compare baseline and 12 week measures of the primary and secondary outcomes through inferential statistical analysis, adopting an intention-to-treat approach. After confirmation of normality (Kolmogorov–Smirnov test) and homoscedasticity (Levene test), we will impute the means for the missing data depending on the nature of the losses: completely random, partially random, or non-random. Two-way analysis of variance will be performed for repeated measures, followed by posthoc Newman–Keuls tests to obtain the group effect (intervention and control), time (between baseline and 12 weeks) and group by time interaction. Significant differences will be considered with an alpha of 5%. The effect size will also be calculated using Cohen’s d coefficient and the difference between the means with their respective 95% CIs.
Ethics and dissemination
The Ethics Committee of the School of Medicine of the University of São Paulo approved this study and the informed consent form that participants will sign (CAAE: 63457822.0.0000.0068, approved 29 November 2022). Participants will sign an informed consent form approved by the ethics committee (online supplemental material 1).
The FOCAIN will generate and share data in accordance with the Brazilian statutory law ‘The General Personal Data Protection Law’ #13 709 (Portuguese: Lei Geral de Proteção de Dados Pessoais, LGPD) and the guidelines established by the Brazilian National Commission on Research Ethics (Portuguese: Comissão Nacional de Ética em Pesquisa, CONEP). All scientific data of potential use will be shared openly with the community. The study will follow the best practices for data management described in the Open Science Framework (OSF) project (https://osf.io/). The FOCAIN will not create its own institutional data repository; we will employ freely available open platforms on the internet for greater transparency and long-term availability. The main platform that will be used is the University Public Repository (https://repositorio.usp.br/).
All information will be collected on physical and electronic forms, and all data will be entered into electronic forms by those responsible for data acquisition blinded to the participants’ allocation. The integrity and validity of the data will be verified at the time of data entry (edit checks) by a data monitoring committee, which will be also responsible for making recommendations on necessary protocol modifications or termination of all or part of the study. The study committee comprises a senior researcher, a coordinator, and assistant researchers. A trimester meeting is held to facilitate the study development. All team members can request meetings as needed. Identification of potential recruits will be done by the project manager and the research assistant. The research assistant will be trained on how to approach the eligible subjects during the initial recruitment contact for the survey (made by phone calls) and how and when to contact them for follow-up and data collection.
The results will be disseminated through peer-reviewed journals, conference proceedings and electronic communications for health professionals working in public and private health institutions. There are plans to expand the preventive programme to other levels of care in Limeira, to other municipalities in the state of São Paulo, and to the rest of Brazil.
Discussion
There is an urgent need to produce knowledge with, in, and for the primary healthcare sector regarding preventive intervention for the diabetic foot and disseminate the results of implementation studies to eliminate the gap between science and practice. This study intends to narrow this gap. More than propagating the quantitative results and sharing technology, it is necessary to share the implementation facilitators, the barriers encountered during the process of transferring the academic knowledge to the public health scenario, and the changes that are necessary in order to increase scalability and support implementation in other locations and contexts (nationally or internationally).
Several implementation studies retrospectively assess the implementation, raising the issue of barriers and facilitators after the entire process is completed. Only a few studies have included the preimplementation and creating a structure for implementation phases. One of the strengths of this protocol is to include all four phases foreseen in Implementation Science studies and accomplish them using a mixed-methods approach. We will carry out both preimplementation phases before implementing the intervention to better address the context and conditions in which the intervention will be implemented. In both preimplementation phases, we will actively listen to the stakeholders’ demands and perceptions. Considering a scenario of several burdens, such as a bureaucratic, fragmented, and resourceless SUS management, effective and sustainable implementation can be a challenge, as stakeholders may present demands that cannot be met, such as those related to public management, cooperation and goodwill, and political opportunities.
Management’s involvement is a major challenge given that political issues greatly influence how processes are conducted. Bureaucracy, combined with the different hierarchical levels within SUS workers and municipal management, could make implementation of the processes less viable and lead to subsequent postponement of deadlines. The establishment of viable and effective partnerships between the university and municipal management should be extensively worked on with the aim of successful implementation.
In a postpandemic period, health workers, especially those in public service, face large workloads with little or no structure. Thus, cases of burnout have grown enormously, impacting motivation and work performance. One of the challenges of the study could be motivating employees to adhere to this innovative project. This issue will be assessed with the CFIR framework in the pre-implementation phase.
The FOCAIN study aims both to disseminate quantitative results and a rehabilitation technology for the foot-ankle for people with diabetes and health professionals and to share the perceptions of different stakeholders during the preimplementation phases, the facilitators and the barriers for the implementation and the changes and adaptations necessary to increase scalability for this preventive intervention implementation in other locations and contexts. We expect to break with the up-down implementation approach and allow the participation of different actors in the process and thus impacting the intervention’s chances of success.
Ethics statements
Patient consent for publication
References
Supplementary materials
Supplementary Data
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Footnotes
Contributors CBR, PNCS, ACS, and ICNS were responsible for the conception and design of the study; CBR and PNCS are responsible for data acquisition and data analysis; CBR, PNCS, ACS, and ICNS are responsible for data interpretation and for drafting the paper. All authors read, provided feedback, and approved the submitted version.
Funding This research is supported by theThis research is supported by the) and Sao Paulo Research Foundation (FAPESP), Brazil (Process #
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.