FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care

Diabetes; Neuropathy, Polyneuropathy (Manifestation) Clinical Trial

— FOCAIN  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05639478
• Other study ID #: FOCAIN
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: December 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study is a type 2 hybrid implementation effectiveness trial, whose objective is to simultaneously test the clinical intervention and the implementation strategy. The study will take place in 4 phases, the first being pre-implementation, whose objective is to gather information about local characteristics, barriers and facilitators, and constitute the implementation team. During the second phase, the implementation team will be responsible for structuring the actions for the implementation of the intervention, adapting it to the context defined in phase 1, developing strategies for the training of primary care workers. In phase 3, we will implement the intervention either using a software or a booklet for people with diabetes and we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 12 weeks of intervention. Reach, adoption and implementation will be evaluated using the RE-AIM tool. In phase 4 - _maintenance - _the municipality will be responsible for maintaining, expanding and improving the changes achieved, promoting the sharing of experience with other public and private institutions, facilitating the diffusion of similar programs. Specifically in the phase 3, a randomized controlled trial will be performed with 356 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform face to face exercises, supervised by physiotherapists for 12-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) range of motion of the ankle and first metatarsophalangeal joint, (3) fuzzy score of the neuropathy severity, (4) Time up and go, (5) hallux and toes strength (by a pressure plate measurement , (6) hallux strength (by the enhanced paper grip test),(7) ulcers and pre-ulcerative lesions and (8) quality of life (EQ-5D). The hypothesis of this study is that the intervention will reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, as well increase range of motion, functionality and quality of life.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 356
• Est. completion date: August 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus type 1 or 2;

• Be able to provide consistent information;

• Ability to walk independently for at least 10 meters;

• Availability to participate in the intervention at the established group time.

Exclusion Criteria:

• Neurological and / or rheumatologic diseases diagnosed;

• Perform physiotherapy intervention throughout the intervention period;

• Receiving any physiotherapy intervention or offloading devices;

• Active foot ulcer;

• Major vascular complications.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes; Neuropathy, Polyneuropathy (Manifestation)
• Polyneuropathies

Intervention

Other:
• Foot-related exercises
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.

Locations

Country	Name	City	State
Brazil	Equipe Multidisciplinar E-Multi	Limeira	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week	The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture available free of charge at: http:// www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.	12 weeks
Secondary	Change from baseline of the toes and hallux strength at 12-week	Toes and hallux (summed) strength will be measured by a pressure plate with the subjects pressing down the plataform with toes standing.	12 weeks
Secondary	Change from baseline of the hallux strength at 12-week	Hallux strength will be measured by the paper grip test using a card where the examiner places it under the participant's hallux, asking the participant to hold it firmly with the hallux. The examiner pulls the card with increasing force while the participant resists	12 weeks
Secondary	Change From Baseline Time up and go at 12-week	Time spent for the subjects to rise from a standard arm chair, walk to a marker 3 m away, turn, walk back, and sit down again.	12 weeks
Secondary	Change from baseline of the Quality of life at 12-week	Score of the EQ-5D questionnaire answered by the participants, which is a generic instrument for measuring health-related quality of life that allows generating an index representing the value of an individual's health status.	12 weeks
Secondary	Change From Baseline of the foot ulcers and pre ulcerative lesions at 12-week	The presence of ulcers or pre-ulcerative lesions will be monitored through photos without identifying the participant. In cases of doubt, there will be a case discussion with a stoma therapist nurse, specialized in wounds on the feet of people with diabetes	12 weeks
Secondary	Reach of the implementation at 12-week	According to the RE-AIM tool, percentage of coverage and representativeness of people with diabetes participating in the intervention. It will be calculated at the individual level by dividing the population reached by the intervention by the total population of people with diabetes eligible for the intervention. Furthermore, the representativeness of this population will be observed based on sociodemographic data and compared to the non-participating group.	12 weeks
Secondary	Adoption of the implementation	According to the RE-AIM tool, percentage of coverage and representativeness of locations that we will implement (18 clusters) and key actors participating in phase 1 and in the professional training in phase 2. Representativeness of the participating units and professionals will also be considered in the analysis	End of phase 1, end of phase 2
Secondary	Implementation at 12 weeks	According to the RE-AIM tool, fidelity to the initially proposed intervention will be evaluated qualitatively and quantitatively, as well as the adaptations - if carried out, through feedback during the course of implementation and in the final evaluation	12 weeks

External Links

•   Description Laboratory of Biomechanics of Human Movement and Posture website
•   University of Sao Paulo website