Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03990857
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2019-06-13
Brief Title:
Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care Quasi-experimental Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICDM2
Brief 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 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 1demonstrate 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
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 1demonstrate 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 andor obesity Will be excluded COPD and IC because they are attended with a specific protocol of care
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 andor obesity Will be excluded COPD and IC because they are attended with a specific protocol of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None