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

Gerencia de Atención Primaria, Madrid

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Multimodal Intervention; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03887403

PI10/00667

Details and patient eligibility

About

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

Full 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.

Enrollment: 310 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Multimodal Intervention

Experimental group

Description:

Multimodal Intervention Based on Person-centered Communication

Treatment:

Other: Usual care

Behavioral: Multimodal Intervention

Usual Care

Active Comparator group

Description:

Patients receive usual advices in primary health care centers

Treatment:

Other: Usual care