FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care
FOCAIN
Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life
1 other identifier
interventional
356
1 country
1
Brief Summary
The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
February 24, 2026
February 1, 2026
3.3 years
November 25, 2022
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline Diabetic Neuropathy Symptoms at 12-week Instrument
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy)
12 weeks
Change From Baseline of the Foot and Ankle range of motion at 12-week
Ankle and first metatarsophalangeal joint will be measured by manual goniometers.
12 weeks
Secondary Outcomes (9)
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week
12 weeks
Change from baseline of the toes and hallux strength at 12-week
12 weeks
Change from baseline of the hallux strength at 12-week
12 weeks
Change From Baseline Time up and go at 12-week
12 weeks
Change from baseline of the Quality of life at 12-week
12 weeks
- +4 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALPatients in the intervention group will perform face to face foot-related exercises for 12 weeks.
Control group
NO INTERVENTIONParticipants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus.
Interventions
Face to face foot-related exercises, supervised by physiotherapist and based in the specific software (Sistema de Orientação do Pé diabético, SOPED) and or booklet, in addition to self-care recommendations and foot care by international consensus. The maximum duration of a session is 40 min and should be be performed 1-2 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the physiotherapist. The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression.
Eligibility Criteria
You may qualify if:
- Adults of both sexes;
- Diabetes mellitus type 1 or 2;
- Residence within the catchment area of the Family Health Units.
- Availability to participate in the intervention at the established group time.
- Clinical diagnosis of dementia;
- Inability to provide reliable and consistent information;
- Perform physiotherapy intervention throughout the intervention period;
- Active foot ulcer or major vascular complications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Equipe Multidisciplinar E-Multi
Limeira, São Paulo, 13481527, Brazil
Related Publications (1)
Rodrigues CB, Soares PNC, Schmitt ACB, Sacco ICN. Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study. BMJ Open. 2024 Feb 5;14(2):e078958. doi: 10.1136/bmjopen-2023-078958.
PMID: 38316587DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabel CN Sacco, PhD
Associate Professor at Medicine of University of São Paulo
- PRINCIPAL INVESTIGATOR
Carla BR da Silva, PT
Researcher of School of Medicine of University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 25, 2022
First Posted
December 6, 2022
Study Start
March 1, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share