- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887403
The COMUNICARE Study: the Effectiveness of a Multimodal Intervention Based on Person-centered Communication (COMUNICARE)
March 21, 2019 updated by: Gerencia de Atención Primaria, Madrid
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
Pragmatic cluster-randomized clinical trial.
An open, multicentric, parallel-group trial with a control group, and with a follow-up period of 1 year.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
310
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Multimodal Intervention
Multimodal Intervention Based on Person-centered Communication
|
Other Names:
|
ACTIVE_COMPARATOR: Usual Care
Patients receive usual advices in primary health care centers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the effectiveness of a complex intervention to improve metabolic control of patients with DM2, as measured through decreases in HbA1c values.
Time Frame: 1-year follow-up period
|
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.
Time Frame: 1-year follow-up period
|
1-year follow-up period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2016
Primary Completion (ACTUAL)
August 1, 2017
Study Completion (ACTUAL)
October 1, 2017
Study Registration Dates
First Submitted
March 21, 2019
First Submitted That Met QC Criteria
March 21, 2019
First Posted (ACTUAL)
March 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 25, 2019
Last Update Submitted That Met QC Criteria
March 21, 2019
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI10/00667
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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