Evaluation of the usefulness of an electronic system to support decision making in the integral control of patients with type 2 diabetes mellitus treated in primary health care
| ISRCTN | ISRCTN11808779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11808779 |
| Secondary identifying numbers | HULP PI-1851 |
- Submission date
- 26/03/2017
- Registration date
- 29/03/2017
- Last edited
- 15/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Patients with T2DM have increased risk of developing problems with their circulation, such as heart attack, stroke or blockages in the arteries in the legs. As well as the damaging effects of high blood sugar levels, these risks are further increased by other factors, such as high blood pressure, high cholesterol and smoking. It is well founded that properly managing these factors can help lower the risks of circulatory system disease and increase chances of survival. This study is looking at a computer tool that aims to help doctors to make decisions about which sugar, blood pressure and cholesterol control goals are recommended in each patient’s case, and how best to achieve these goals. The aim of the study is to assess whether patient’s diabetes is better controlled when their physicians use this decision support program.
Who can participate?
Adults who have had T2DM for at least one year.
What does the study involve?
Participants attend a study visit at which their doctor uses the decision support program to make recommendations about how they could reduce their risk of circulation problems, such as through medication or lifestyle modifications using blood pressure readings and information about blood sugar and cholesterol levels. This information is used along with the doctor’s own judgment to see if patients should make any changes to how they manage their condition. After three months, patients return to the clinic in order to find out whether their blood pressure, blood sugar control and cholesterol levels have improved.
In a second part of the study, information is collected from participant’s medical records in order to assess how well their blood pressure, blood sugar and cholesterol were previously controlled.
What are the possible benefits and risks of participating?
There are no guaranteed benefits involved with participating in this study, although patients are expected to be gain better control of their blood pressure, cholesterol and blood sugar levels. There are no risks involved with participating.
Where is the study run from?
1. University Health Centre Dr. Castroviejo (Spain)
2. University Health Centre Reina Victoria (Spain)
3. University Hosptial La Paz (Spain)
When is the study starting and how long is it expected to run for?
June 2014 to October 2016
Who is funding the study?
Ministry of Health, Social Services and Equality (Spain)
Who is the main contact?
Dr Luis M Beltrán
luism.beltranromero@gmail.com
Contact information
Scientific
Hospital Universitario Virgen del Rocío
Servicio de Medicina Interna
Seville
41013
Spain
 ORCID ID |
0000-0001-8048-9106 |
|---|---|
| Phone | +34 67 987 80 80 |
| luism.beltranromero@gmail.com |
Study information
| Study design | Multi-centre interventional non-randomised study with a prospective phase (interventional) and retrospective phase (observational) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | ISRCTN11808779_PIS_27Mar17_Spanish.pdf |
| Scientific title | Electronic clinical decision support system and multifactorial risk factor control in patients with type 2 diabetes in primary health care |
| Study acronym | ARTERIOTARGET Project-1 |
| Study objectives | An electronic Clinical Decision Support System (eCDSS) that collects relevant clinical information and combines it with the CPG recommendations to provide personalised recommendations could be useful to improve the multifactorial control of patients with T2DM managed in primary care. |
| Ethics approval(s) | The Ethics Committee at La Paz University Hospital (Madrid), 25/11/2014, ref: HULP PI-1851 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | All participants attend a standard clinical visit in which their responsible physicians explain and propose the study. If they agree to take part, then blood pressure (BP) is measured and analysed and the physician uses the electronic decision support system (Arteriotarget) to advise recommendations in combination with their clinical judgement. If all vascular factors are well controlled or if the physician does not agree with Arteriotarget recommendations the patient did not receive any specific intervention. In any case a follow-up visit is scheduled at 12 weeks +/- 15 days and then blood pressure and laboratory parameters are reevaluated. Additionally patients are asked about clinical adverse events such hypoglycemia or hypotension. In the second part of the study, medical records from 12 months to 3 months before baseline visit are reviewed for BP, LDLc, and HbA1c from the year before the study initiation to baseline. |
| Intervention type | Behavioural |
| Primary outcome measure | Proportion of patients with T2DM with multi-factorial control of blood pressure, LDL cholesterol, and HbA1c is assessed through clinical examinations and blood testing at baseline and 12 weeks |
| Secondary outcome measures | 1. Proportion of controlled patients for each individual factor (blood pressure, LDL cholesterol and HbA1c) is assessed through clinical examinations and blood testing at baseline and 12 weeks 2. Mean change in ystolic BP (SBP), diastolic BP (DBP), cLDL, and HbA1c is assessed through clinical examinations and blood testing at baseline and 12 weeks 3. Proportion of patients with potential adverse events attributable to intensification of treatment (glomerular filtration rate decrease >20%, CPK elevated 3 times the upper limit of normal [ULN], GPT elevated 3 times ULN, hypo- or hyperkalaemia, and hypoglycemia or hypotension episodes) is assessed through blood testing at 12 weeks and focused clinical interview (hypoglycaemia or hypotension episodes) 4. Primary care physicians’ satisfaction with the eCDSS is evaluated using an anonymous, semi-quantitative survey at the end of recruitment |
| Overall study start date | 30/06/2014 |
| Completion date | 31/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 159 (assuming a 10% patient loss) |
| Key inclusion criteria | 1. Aged 18 to 65 years 2. T2DM diagnosed at least one year before |
| Key exclusion criteria | 1. Over 65 years 2. Poor short-term prognosis according to clinical judgement (advanced comorbidities, frailty, and severe cognitive impairment) |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 31/10/2015 |
Locations
Countries of recruitment
- Spain
Study participating centres
Madrid
28035
Spain
Madrid
28003
Spain
Madrid
28046
Spain
Sponsor information
Hospital/treatment centre
Metabolic Vascular Unit
Paseo de la Castellana 261
Madrid
28046
Spain
| Phone | +34 91 334 03 88 |
|---|---|
| carolvelascoes@hotmail.com | |
"ROR" |
https://ror.org/01s1q0w69 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Health, Social Services and Equality
- Location
- Spain
Results and Publications
| Intention to publish date | 01/05/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a relevant international peer-review journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from rosa.torres@salud.madrid.org and carolvelascoes@hotmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/03/2017 | 06/04/2017 | No | Yes | |
| Participant information sheet | 27/03/2017 | 06/04/2017 | No | Yes | |
| Results article | results | 01/10/2017 | Yes | No |
Additional files
- ISRCTN11808779_PIS_27Mar17_Spanish.pdf
- Uploaded 06/04/2017
- ISRCTN11808779_PIS_27Mar17_English.pdf
- Uploaded 06/04/2017
Editorial Notes
15/11/2017: Publication reference has been added
06/04/2017: The participant information sheets have been uploaded.
