Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of the Balearic Islands
About this trial
The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.
Eligibility criteria
Qualifiers
Diagnosis of type 1 or type 2 diabetes mellitus.
Aged 18 years or older.
Attending nursing consultations at participating primary care centers during the study period.
Disqualifiers
Patients with gestational diabetes.
Patients with diabetic foot ulcers prior to the start of the study.
Patients with lower limb amputations prior to the start of the study.
Trial design
Treatments tested in this trial
- Implementation strategy developed using the Implementation Mapping model to enhance the effective integration of the Protocol for Assistance to People with Diabetic Foot
- Sham Comparator
Treatment groups
1,520 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of the Balearic Islands
Lead sponsor
Universitat de les Illes Balears
Collaborator
Source ClinicalTrials.gov