Diabetes Mellitus Type 2NCT01849731
Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior
A study testing Face-to-face and Face-to-face intervention plus telephone reinforcement in people with Diabetes Mellitus Type 2, run by Andalusian School of Public Health at 1 site in Spain.
Trial summary
The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Face-to-face and Face-to-face intervention plus telephone reinforcement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of DM2,
- Over 18 years,
- Low educational level (no college to GBS or ESO),
- Inadequate glycemic control (glycosylated hemoglobin levels above 7%)
Who cannot join
- Physical or mental condition that prevents the completion of the intervention - complications arising from severe DM2 altering routine medical monitoring.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Face-to-face, Face-to-face intervention plus telephone reinforcement
- Keywords
- Diabetes Mellitus type 2;, Primary Care, healthcare inequalities;, Diabetes self-management,, Quality of diabetes 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.
Face-to-faceOther
is carried out by the GPs during the clinic visit and consists of seven visits, one every three months. Each session consists of completing a diabetes care record sheet (DCRS) together with the patient. The DCRS consists of two parts: Five questions on self-care activities in the last three months and a graph with previously measured HbA1c levels. This information is completed at each session, resulting in a graph showing the evolution of glycaemic control related to self-care activities. The DCRS is explained patients, emphasising the relationship between self-care and glycemic control. At the end of the session, patients are given a copy of the DCRS and suggested to show it and discuss it with their relatives.
Face-to-face intervention plus telephone reinforcementOther
In this group patients receive the above described intervention A plus a telephone reinforcement It consists on five telephone calls lasting about 10 minutes each, to provide advice on carrying out physical exercise and eating a balanced diet and to encourage the use of health services related to diabetes control. Any problems or doubts that patients have stemming from any aspect of diabetes care are also discussed. Telephone reinforcement is carried out by a professional who has previously been trained in promoting T2DM self-management and in motivational interviewing techniques.
| Study group | Role | What they receive |
|---|---|---|
| Intervention A | Experimental | Face-to face intervention Receives: Other: Face-to-face |
| Intervention B | Experimental | Face-to-face intervention plus telephone reinforcement Receives: Other: Face-to-face intervention plus telephone reinforcement |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Haemoglobin levels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian School of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Clara Bermúdez-Tamayo, Andalusian School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849731
- Sponsor's protocol ID
- PI-0096-2010
- Status last verified
- May 2013
- First submitted
- 6 May 2013
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ricci-Cabello I, Olry de Labry-Lima A, Bolivar-Munoz J, Pastor-Moreno G, Bermudez-Tamayo C, Ruiz-Perez I, Quesada-Jimenez F, Moratalla-Lopez E, Dominguez-Martin S, de los Rios-Alvarez AM, Cruz-Vela P, Prados-Quel MA, Lopez-De Hierro JA. Effectiveness of two interventions based on improving patient-practitioner communication on diabetes self-management in patients with low educational level: study protocol of a clustered randomized trial in primary care. BMC Health Serv Res. 2013 Oct 23;13:433. doi: 10.1186/1472-6963-13-433.
PubMed 24153053
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior
- ClinicalTrials.gov ID
- NCT01849731
- Acronym / sponsor ID
- PI-0096-2010
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes Mellitus type 2;, Primary Care, healthcare inequalities;, Diabetes self-management,, Quality of diabetes care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Andalusian School of Public HealthOther government
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 8 May 2013 (estimated)
- 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.
The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention A | Experimental | Other: Face-to-faceFace-to face intervention |
| Intervention B | Experimental | Other: Face-to-face intervention plus telephone reinforcementFace-to-face intervention plus telephone reinforcement |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of DM2,
- Over 18 years,
- Low educational level (no college to GBS or ESO),
- Inadequate glycemic control (glycosylated hemoglobin levels above 7%)
Key exclusion criteria (1 listed)
- Physical or mental condition that prevents the completion of the intervention - complications arising from severe DM2 altering routine medical monitoring.
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 |
|---|---|---|
| Face-to-faceis carried out by the GPs during the clinic visit and consists of seven visits, one every three months. Each session consists of completing a diabetes care record sheet (DCRS) together with the patient. The DCRS consists of two parts: Five questions on self-care activities in the last three months and a graph with previously measured HbA1c levels. This information is completed at each session, resulting in a graph showing the evolution of glycaemic control related to self-care activities. The DCRS is explained patients, emphasising the relationship between self-care and glycemic control. At the end of the session, patients are given a copy of the DCRS and suggested to show it and discuss it with their relatives. | Other | Intervention A |
| Face-to-face intervention plus telephone reinforcementIn this group patients receive the above described intervention A plus a telephone reinforcement It consists on five telephone calls lasting about 10 minutes each, to provide advice on carrying out physical exercise and eating a balanced diet and to encourage the use of health services related to diabetes control. Any problems or doubts that patients have stemming from any aspect of diabetes care are also discussed. Telephone reinforcement is carried out by a professional who has previously been trained in promoting T2DM self-management and in motivational interviewing techniques. | Other | Intervention B |
Primary outcome
Glycosylated Haemoglobin levels
Time frame: one year
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 8 May 2013.
- Derived from this study: PubMed 24153053Ricci-Cabello I, Olry de Labry-Lima A, Bolivar-Munoz J, Pastor-Moreno G, Bermudez-Tamayo C, Ruiz-Perez I, Quesada-Jimenez F, Moratalla-Lopez E, Dominguez-Martin S, de los Rios-Alvarez AM, Cruz-Vela P, Prados-Quel MA, Lopez-De Hierro JA. Effectiveness of two interventions based on improving patient-practitioner communication on diabetes self-management in patients with low educational level: study protocol of a clustered randomized trial in primary care. BMC Health Serv Res. 2013 Oct 23;13:433. doi: 10.1186/1472-6963-13-433.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face and Face-to-face intervention plus telephone reinforcement in people with Diabetes Mellitus Type 2, run by Andalusian School of Public Health at 1 site in Spain.
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 4 inclusion and 1 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 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Glycosylated Haemoglobin levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01849731, which also lists 1 linked publication.
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 8 May 2013.