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Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control

NCT04932356 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-08-31

No results posted yet for this study

Summary

Diabetes Mellitus (DM) is one of the most prevalent chronic diseases worldwide and with a significant impact on health spending.

The literature identifies that the telephone improves the process of clinical care and patient outcomes. Programs are known to have demonstrated improvements in HbA1c outcome in DM2.

In the majority of patients their follow-up is carried out from primary care, where they occupy a third of the visits, it is a main reason for consultation.

The mobile phone is becoming an interesting tool for therapeutic education.

The objective: To decrease the HbA1c value by 10% in patients who have their HbA1c \>9% and 0.5% in those who have an HbA1c value \<9%-Reduce the number of spontaneous visits in nursing consultations.

Know the attitude and motivations of the patients participating in the study It will be a probabilistic randomized intervention study at the Mas Font Primary Care Center in Viladecans (Barcelona).

According to medical history as of December 31, 2020, there were 1554 patients diagnosed with DM2, 402 DM2 patients with poor control (HbA1c \>8%) Patients who meet inclusion criteria will be contacted by telephone or at consultations and will be offered to participate and sign consent.

They are then automatically randomized to intervention or control group. Study participants will be visited in person every six months and both groups will follow the center's protocol in face-to-face visits, The intervention group will be reinforced with a fortnightly telephone visit.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Therapeutic education by phone

The patients who participate in the intervention group, after their face-to-face visit, will undergo a fortnightly reinforcement by telephone of diabetes education (review of diet, physical exercise, doubts about insulin or oral medication and the registry of blood glucose controls). In addition, emotional support will be provided to the patient, along with a semester calendar with scheduled calls to carry out the intervention, at a specific time.

OTHER

Therapeutical education traditional

The patients participating in the study will be visited in person every six months where the control group will follow the usual protocol of the health center in the face-to-face visits, with their respective analyzes and pertinent tests, together with health education and adherence to pharmacological treatment.

Sponsors & Collaborators

  • Mª Dolores Rodríguez Garrido

    lead OTHER

Principal Investigators

  • MªDolores Rodriguez, diploma · ICS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2022-08-31
Completion
2023-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04932356 on ClinicalTrials.gov