Diabetes Mellitus, Type 2COMUNICARENCT03887403
The COMUNICARE Study: the Effectiveness of a Multimodal Intervention Based on Person-centered Communication
A study testing Multimodal Intervention in people with Diabetes Mellitus, Type 2, run by Gerencia de Atención Primaria, Madrid.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Multimodal Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
About this study
Official title: 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.
Read the 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
- Being tested
- Multimodal Intervention, Usual care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal InterventionBehavioural
Also called Usual care
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intervention | Experimental | Multimodal Intervention Based on Person-centered Communication Receives: Behavioral: Multimodal Intervention; Other: Usual care |
| Usual Care | Active comparator | Patients receive usual advices in primary health care centers Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-year follow-up period
Assess the effectiveness of the intervention to increase adherence to OAD treatment.
Measured: 1-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study startMar 2016
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887403
- Sponsor's protocol ID
- PI10/00667
- Acronym
- COMUNICARE
- Status last verified
- Aug 2017
- First submitted
- 21 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03887403
- Acronym / sponsor ID
- COMUNICARE / PI10/00667
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intervention | Experimental | Behavioral: Multimodal Intervention, Other: Usual careMultimodal Intervention Based on Person-centered Communication |
| Usual Care | Active comparator | Other: Usual carePatients receive usual advices in primary health care centers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal InterventionAlso: Usual care | Behavioural | Multimodal Intervention |
| Usual care | Other | Multimodal Intervention, Usual Care |
Primary outcome
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.
Assess the effectiveness of the intervention to increase adherence to OAD treatment.
Time frame: 1-year follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Intervention in people with Diabetes Mellitus, Type 2, run by Gerencia de Atención Primaria, Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.