Trials / Completed
CompletedNCT03887403
The COMUNICARE Study: the Effectiveness of a Multimodal Intervention Based on Person-centered Communication
Randomized Clinical Trial to Evaluate the Effectiveness of a Multimodal Intervention Based on Person-centered Communication With Health and Safety Outcomes in Diabetic Patients. The COMUNICARE Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 310 (actual)
- Sponsor
- Gerencia de Atención Primaria, Madrid · Other Government
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Multimodal Intervention | |
| OTHER | Usual care |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2017-08-01
- Completion
- 2017-10-01
- First posted
- 2019-03-25
- Last updated
- 2019-03-25
Source: ClinicalTrials.gov record NCT03887403. Inclusion in this directory is not an endorsement.