Type 2 DiabetesPICDM2NCT03990857
Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care
A study testing Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care in people with Type 2 Diabetes, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Introduction Type 2 Diabetes is a very prevalent chronic disease in our environment. It usually exists with other chronic diseases. Although drug intensification at the time of new diagnosis has proven effective in reduction of cardiovascular and diabetes control and complications, an intensification of comprehensive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 30 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People between both sexes between 18 and 80 years old with a recent (less than 5 months)diagnosis of DM 2 + comorbidity , assigned to the nurses that participate in the study and who give their consent to participate.
Who cannot join
- People who participate in a similar project.
- People with difficulty maintaining their participation for 12 months.
- People who have difficulty understanding and expressing themselves in Catalan or Spanish.
- People who have serious health problems: serious mental disease, terminal processes.
- People with COPD and IC, because they were included in another study with a specific care plan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care: Quasi-experimental Study.
Introduction
Type 2 Diabetes is a very prevalent chronic disease in our environment. It usually exists with other chronic diseases. Although drug intensification at the time of new diagnosis has proven effective in reduction of cardiovascular and diabetes control and complications, an intensification of comprehensive health education has not been proven so. Currently, there is a great variability in practices of Primary Care nurses in front of the health education in the moment of new diagnosis.
Read more
The aim of this study is to evaluate the effectiveness of a systematic protocol with an integrated care in people with newly diagnosed type 2 diabetes (DM2) and associated comorbidities, which included 5 structured individual visits post-diagnosis with the Primary care nurse.
Methods
Quasi-experimental design, comparing a group of individuals taking part in the intervention with a similar group receiving usual care. Data will be collected at the beginning, at the end of the intervention and after 6 and 12 months. 10 primary care centers in the city of Barcelona will be selected on a convenience basis as IG and CG. The subjects of the GC will be monitored as usual. Performed analysis will be the baseline comparability between GI and GC in relationship to different variables as well as the changes in dependent variables along the study; establishing comparisons between GC and GI . The results will be measured in terms of quality of life related to health, development of biological parameters (HbA1c and weight) and compliance with the therapeutic plan.
Discussion
The results of this study will help to 1)demonstrate that by intensifying the hygienic-dietetic measures in the initial stage of DM2 diagnosis, the disease and associated co-morbidities are controlled in a better way. 2) validate a material that allows to decrease the variability in the care offered by primary care nurses to people in this group.
Read the detailed description
Objectives
To evaluate the effectiveness of the systematic application of the comprehensive care protocol in people who debut in DM2 and associated comorbidities, applied during 3 months in primary care, in terms of quality of life related to Health, weigh loss and Glycosylated hemoglobin (HbA1c) compared to people who receive normal practice.
Secondary: To evaluate the effectiveness of the systematic application of the comprehensive care protocol of DM and associated comorbidities, during 3 months in primary care, in the parameters:
- Evolution of the specific biological parameters: TA, BMI, lipid profile, abdominal perimeter.
- Evolution of the consumption of drugs.
- Compliance with dietary recommendations.
- Increase in physical activity.
- Satisfaction / opinion of the participants. According to a questionnaire of user satisfaction of the ICS adapted to our study.
- Health frequentation in Primary Care Centers.
Methods and Analysis Study Design: A quantitative quasi-experimental design, multicenter, one-year follow-up, comparing a group of patients with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities, the intervention (IG), with a group of similar characteristics who receive the usual care (CG). The response variables will be evaluated before starting the care according to protocol, after (3 months) and at 6 and 12 months of initiating the intervention, in both groups.
Scope of the study: It will be developed in 10 urban primary care health centers, in 5 centers the intervention will be carried out and in 5 the controls will be selected. The allocation of a center as an intervention or comparison will be random. In the calculation of the sample the cluster effect attributable to this design has been considered.
Subjects of the study: The study population will consist of patients attended in the selected Primary Care Centers with a new diagnosis of DM2 (less than 5 months from the debut) that present comorbidity with an other chronic cardiovascular condition (Hypertension, dyslipidemia and/or obesity). Will be excluded COPD and IC, because they are attended with a specific protocol of care.
- Conditions
- Type 2 Diabetes
- Being tested
- Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care
- Keywords
- comorbidities comprehensive 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.
Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary CareOther
This comprehensive intervention is developed in a structured way in the Primary care nurse office. 5 individual intensive visits will be carried out with a weekly or bi-weekly frequency (according to the learning process) to work for an integral care and to transmit the knowledge and skills required. The maximum time expected to receive this 5 visits is 3 months. At least one of the visits, preferably the one that deals with dietary aspects, the patient is asked to be visited with the partner, child or cohabiting person. The research team elaborated the support material with the minimum contents that every patient that begins with T2DM and other chronic pathologies should know. It allows incorporating cultural and emotional aspects. It was agreed with hospital diabetes educators and family doctors. A graphic designer gave an enticing design. A group of patients verified their utility and intelligibility. It is delivered to the person and discussed during the intensification.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group of participants with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities attended in Primary care nurse office Receives: Other: Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care |
| comparison group | No intervention | Participants in the study that do not receive the intervention. usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is being assessed in Health Related Quality of Life will be measured through the EuroQoL (EQ-5D)
The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Measured: The outcome measure will be measured before, up to 3,6 and 12 months to assess its change
HbA1c
Glycosylated hemoglobin for having a clinical response.
Measured: up to 12 months.
Change is being assessed in Weigh
Weigh for having a clinical response.
Measured: The outcome measure will be measured before, up to 3,6 and 12 months to assess its change
Secondary outcomes (3)
Dietary habits: PREDIMED
with the Predimed questionnaire. It consists of 14 questions. If the answer corresponds to a healthy practice, 1 point per question is counted. The range of answers goes from 0 (worst result) to 14 (best result).
Measured: baseline, up to 3,6 and 12 months.
Physical activity: IPAQ
with the IPAQ questionnaire. The IPAQ asks about the exercise performed the last 7 days. It is structured to provide walking scores, moderate and high intensity activities. The final score of the short form requires the sum of the duration (in minutes) and frequency (days). The data obtained by the IPAQ can be shown as a continuous variable, for this each activity is measured by its energy requirements defined as MET's and in that way can be expressed in MET's-minute. More METs correspond to more exercise. Higher values represent a better outcome.
Measured: baseline, up to 3,6 and 12 months.
Use of services in the last year
(Primary Care visits). Number or visits in GP and nurse office and at home during the year of the study.
Measured: Measure the year after diagnosis in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Sep 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
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 Type 2 DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990857
- Sponsor's protocol ID
- 4R16/045
- Acronym
- PICDM2
- Status last verified
- Feb 2021
- First submitted
- 13 Jun 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The derived data supporting the findings of this study will be available from the corresponding author \[CL\] on request.
Publications
Lapena C, Borras E, Digon C, Aznar R, Del Val Garcia JL, Castelblanco E, Garaikoetxea A, Laguna V. Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-experimental trial. BMJ Open. 2020 Jun 23;10(6):e033725. doi: 10.1136/bmjopen-2019-033725.
PubMed 32580980
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care: Quasi-experimental Study.
- ClinicalTrials.gov ID
- NCT03990857
- Acronym / sponsor ID
- PICDM2 / 4R16/045
- Conditions
- Type 2 Diabetes
- Keywords
- comorbidities comprehensive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 19 Jun 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.
Introduction
Type 2 Diabetes is a very prevalent chronic disease in our environment. It usually exists with other chronic diseases. Although drug intensification at the time of new diagnosis has proven effective in reduction of cardiovascular and diabetes control and complications, an intensification of comprehensive health education has not been proven so. Currently, there is a great variability in practices of Primary Care nurses in front of the health education in the moment of new diagnosis.
The aim of this study is to evaluate the effectiveness of a systematic protocol with an integrated care in people with newly diagnosed type 2 diabetes (DM2) and associated comorbidities, which included 5 structured individual visits post-diagnosis with the Primary care nurse.
Methods
Quasi-experimental design, comparing a group of individuals taking part in the intervention with a similar group receiving usual care. Data will be collected at the beginning, at the end of the intervention and after 6 and 12 months. 10 primary care centers in the city of Barcelona will be selected on a convenience basis as IG and CG. The subjects of the GC will be monitored as usual. Performed analysis will be the baseline comparability between GI and GC in relationship to different variables as well as the changes in dependent variables along the study; establishing comparisons between GC and GI . The results will be measured in terms of quality of life related to health, development of biological parameters (HbA1c and weight) and compliance with the therapeutic plan.
Discussion
The results of this study will help to 1)demonstrate that by intensifying the hygienic-dietetic measures in the initial stage of DM2 diagnosis, the disease and associated co-morbidities are controlled in a better way. 2) validate a material that allows to decrease the variability in the care offered by primary care nurses to people in this group.
Detailed description
Objectives
To evaluate the effectiveness of the systematic application of the comprehensive care protocol in people who debut in DM2 and associated comorbidities, applied during 3 months in primary care, in terms of quality of life related to Health, weigh loss and Glycosylated hemoglobin (HbA1c) compared to people who receive normal practice.
Secondary: To evaluate the effectiveness of the systematic application of the comprehensive care protocol of DM and associated comorbidities, during 3 months in primary care, in the parameters:
- Evolution of the specific biological parameters: TA, BMI, lipid profile, abdominal perimeter.
- Evolution of the consumption of drugs.
- Compliance with dietary recommendations.
- Increase in physical activity.
- Satisfaction / opinion of the participants. According to a questionnaire of user satisfaction of the ICS adapted to our study.
- Health frequentation in Primary Care Centers.
Methods and Analysis Study Design: A quantitative quasi-experimental design, multicenter, one-year follow-up, comparing a group of patients with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities, the intervention (IG), with a group of similar characteristics who receive the usual care (CG). The response variables will be evaluated before starting the care according to protocol, after (3 months) and at 6 and 12 months of initiating the intervention, in both groups.
Scope of the study: It will be developed in 10 urban primary care health centers, in 5 centers the intervention will be carried out and in 5 the controls will be selected. The allocation of a center as an intervention or comparison will be random. In the calculation of the sample the cluster effect attributable to this design has been considered.
Subjects of the study: The study population will consist of patients attended in the selected Primary Care Centers with a new diagnosis of DM2 (less than 5 months from the debut) that present comorbidity with an other chronic cardiovascular condition (Hypertension, dyslipidemia and/or obesity). Will be excluded COPD and IC, because they are attended with a specific protocol of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary CareGroup of participants with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities attended in Primary care nurse office |
| comparison group | No intervention | –Participants in the study that do not receive the intervention. usual care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People between both sexes between 18 and 80 years old with a recent (less than 5 months)diagnosis of DM 2 + comorbidity , assigned to the nurses that participate in the study and who give their consent to participate.
Key exclusion criteria (5 listed)
- People who participate in a similar project.
- People with difficulty maintaining their participation for 12 months.
- People who have difficulty understanding and expressing themselves in Catalan or Spanish.
- People who have serious health problems: serious mental disease, terminal processes.
- People with COPD and IC, because they were included in another study with a specific care plan.
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 |
|---|---|---|
| Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary CareThis comprehensive intervention is developed in a structured way in the Primary care nurse office. 5 individual intensive visits will be carried out with a weekly or bi-weekly frequency (according to the learning process) to work for an integral care and to transmit the knowledge and skills required. The maximum time expected to receive this 5 visits is 3 months. At least one of the visits, preferably the one that deals with dietary aspects, the patient is asked to be visited with the partner, child or cohabiting person. The research team elaborated the support material with the minimum contents that every patient that begins with T2DM and other chronic pathologies should know. It allows incorporating cultural and emotional aspects. It was agreed with hospital diabetes educators and family doctors. A graphic designer gave an enticing design. A group of patients verified their utility and intelligibility. It is delivered to the person and discussed during the intensification. | Other | Intervention |
Primary outcome
Change is being assessed in Health Related Quality of Life will be measured through the EuroQoL (EQ-5D)
Time frame: The outcome measure will be measured before, up to 3,6 and 12 months to assess its change
The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
HbA1c
Time frame: up to 12 months.
Glycosylated hemoglobin for having a clinical response.
Change is being assessed in Weigh
Time frame: The outcome measure will be measured before, up to 3,6 and 12 months to assess its change
Weigh for having a clinical response.
3 secondary outcomes
Dietary habits: PREDIMED
Time frame: baseline, up to 3,6 and 12 months.
Physical activity: IPAQ
Time frame: baseline, up to 3,6 and 12 months.
Use of services in the last year
Time frame: Measure the year after diagnosis in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 32580980Lapena C, Borras E, Digon C, Aznar R, Del Val Garcia JL, Castelblanco E, Garaikoetxea A, Laguna V. Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-experimental trial. BMJ Open. 2020 Jun 23;10(6):e033725. doi: 10.1136/bmjopen-2019-033725.
- Individual participant dataSharing planned: Yes. The derived data supporting the findings of this study will be available from the corresponding author [CL] on request.
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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 Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care in people with Type 2 Diabetes, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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?
Results are not available in the source record.
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?
Change is being assessed in Health Related Quality of Life will be measured through the EuroQoL (EQ-5D) (time frame: The outcome measure will be measured before, up to 3,6 and 12 months to assess its change). The study lists 3 primary outcomes in all. 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 NCT03990857, 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 10 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.