The COMUNICARE Study: the Effectiveness of a Multimodal Intervention Based on Person-centered Communication

NCT03887403 | Completed

• 1 other identifier: PI10/00667
• Study Type: interventional
• Target: 310
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pragmatic cluster-randomized clinical trial. An open, multicentric, parallel-group trial with a control group, and with a follow-up period of 1 year.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Assess the effectiveness of a complex intervention to improve metabolic control of patients with DM2, as measured through decreases in HbA1c values.

  Assess the effectiveness of a complex intervention based on person-centered interviewing (PCI), in contrast to usual informational meetings, to improve metabolic control of patients with DM2 that attend PC consultations, as measured through decreases in HbA1c values.

  1-year follow-up period

• Assess the effectiveness of the intervention to increase adherence to OAD treatment.

  1-year follow-up period

Study Arms (2)

Multimodal Intervention

EXPERIMENTAL

Multimodal Intervention Based on Person-centered Communication

Behavioral: Multimodal Intervention; Other: Usual care

Usual Care

ACTIVE COMPARATOR

Patients receive usual advices in primary health care centers

Other: Usual care

Interventions

Multimodal Intervention BEHAVIORAL

Also known as: Usual care

Multimodal Intervention

Usual care OTHER

Multimodal Intervention; Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range between 40 and 75 years.
• Patients with DM2 undergoing regular treatment with at least one type of OAD for the last 6 months.
• HbA1c ≥7.5% in the last laboratory test.
• PC patients that have attended consultation in at least 2 occasions for reasons related to their diabetes.
• Patients that will remain in the HC area during the follow-up period.
• Patients willing to provide Informed Consent to participate in the study.

You may not qualify if:

• Patients whose diabetes is monitored in specialized care consultations or private clinics, and attend the HC only for medical prescription.
• Patients diagnosed with a terminal disease and a survival prognosis of less than 1 year.
• Patients already taking part in another clinical trial.
• Patients on a surgery waiting list and/or not expecting to complete the follow-up period.
• Pregnant women.
• Patients with cognitive impairment.
• Patients suffering from severe chronic pathologies (kidney failure requiring hemodialysis; cardiac insufficiency of a degree equal to or higher than III/IV according to the classification by the New York Heart Association; respiratory insufficiency requiring treatment with continuous oxygen therapy and/or chemotherapy).
• Patients suffering from a psychiatric disorder that requires neuroleptics treatment.
• Drug use or alcohol abuse (\>60 gr/day).

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 25, 2019

Record last verified: 2017-08