Clinical trial NCT05639478: FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes; Neuropathy, Polyneuropathy (Manifestation)
Keywords: exercise therapy
diabetic foot
preventive care
foot-related exercises
musculoskeletal functions
primary health care
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Assignment
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline Diabetic Neuropathy Symptoms at 12-week Instrument
timeFrame: 12 weeks
measure: Change From Baseline of the Foot and Ankle range of motion at 12-week
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week
timeFrame: 12 weeks
measure: Change from baseline of the toes and hallux strength at 12-week
timeFrame: 12 weeks
measure: Change from baseline of the hallux strength at 12-week
timeFrame: 12 weeks
measure: Change From Baseline Time up and go at 12-week
timeFrame: 12 weeks
measure: Change from baseline of the Quality of life at 12-week
timeFrame: 12 weeks
measure: Change From Baseline of the foot ulcers and pre ulcerative lesions at 12-week
timeFrame: 12 weeks
measure: Reach of the implementation at 12-week
timeFrame: 12 weeks
measure: Adoption of the implementation
timeFrame: End of phase 1, end of phase 2
measure: Implementation at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Limeira
country: Brazil
facility: Equipe Multidisciplinar E-Multi
state: São Paulo
Study officials:
affiliation: Associate Professor at Medicine of University of São Paulo
name: Isabel CN Sacco, PhD
role: STUDY_DIRECTOR
affiliation: Researcher of School of Medicine of University of São Paulo
name: Carla BR da Silva, PT
role: PRINCIPAL_INVESTIGATOR
References: