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

NCT ID: NCT03887403

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-10-31

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.

Detailed Description

Pragmatic cluster-randomized clinical trial. An open, multicentric, parallel-group trial with a control group, and with a follow-up period of 1 year. Randomization unit: health care professionals. Analysis unit: patients and health care workers. Scope: primary care (PC) health centers in the Community of Madrid (Spain). Population sample: patients of 40 to 75 years of age with DM2, HbA1c ≥7.5%, on oral antidiabetic drugs (OAD) treatment, who had attended PC consultation during the last year. Sample size: 250 patients (125 per group). Main objective: assess the effectiveness of an intervention based on person-centered interviewing (PCI) to improve metabolic control and increase OAD treatment adherence in patients with DM2. Intervention: four-component intervention including 1) Training of health care professionals (doctors and nurses) on PCI, 2) Practice of PCI techniques, 3) Information card for patients and family members, 4) Instructions sheet on drug prescription. Control arm: usual clinical practice. Variables: 1) Patients: Main: metabolic control (difference of HBA1c ≥0.5%), and OAD treatment adherence (average increase of 50-75%); Secondary: cardiovascular risk, compliance with clinical practice guidelines, complications related to DM2, satisfaction with treatment, adverse effects of medication, usage of health care services. 2) Healthcare workers: professional burnout. Follow-up period: 1 year. Analysis: multi-level models.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Multimodal Intervention

Multimodal Intervention Based on Person-centered Communication

Group Type: EXPERIMENTAL

Multimodal Intervention

Intervention Type: BEHAVIORAL

Usual care

Intervention Type: OTHER

Usual Care

Patients receive usual advices in primary health care centers

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Interventions

Multimodal Intervention

Intervention Type: BEHAVIORAL

Usual care

Intervention Type: OTHER

Other Intervention Names

Usual care

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PI10/00667

Identifier Type: -

Identifier Source: org_study_id