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New Patient Support Program in Type 2 Diabetes

The Community Pharmacist and the Case Management of Diabetic Patient - No Profit Observational Study on the Role of the Community Pharmacist and the Pharmacy of the Services in the Diabetic Patient Case Management

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03752567
Enrollment
40
Registered
2018-11-26
Start date
2018-11-01
Completion date
2019-10-31
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

adherence, terapy, follow up, community pharmacy, pharmacist, case manager, telemedicine, pharmacy of service, fundus camera, ecg, local pharmacist, general physician

Brief summary

Non-profit observational study on the role of the community pharmacist and the pharmacy of services in the case management of the diabetic patient

Detailed description

Over the last few years, the Italian National Health Service has witnessed numerous and substantial changes, even more evident if one looks at the workload that this system is called to face when it comes to chronic diseases. In fact, while the progress of science has led to better outcomes in the treatment of acute diseases resulting in an increase in the average age of the population and an increase in the number of people suffering from chronic diseases, even multiple, on the other the changed socio-economic conditions activities have led to an increase in the number of elderly and socially fragile individuals. It takes very little to understand that these epidemiological and socio-sanitary mutations pose a serious threat to the stability of the investigator's health system. To meet these new needs, the different countries of the world are analyzing and adopting various models of chronic disease management. Even if with different methodologies, all the models developed so far put the patient at the center of attention, in its uniqueness and with its needs, and propose to provide the latter with complete assistance, through the integration of health and social services. In this scenario, also the role of pharmacist, historically linked to the dispensation of drugs upon presentation of a medical prescription and to a final control action to ensure a delivery of medicines in total safety, over time has evolved. In order to carry on this evolution, the pharmacist has been asked for new skills, to realize what has been defined as the pharmacy of services, through which the pharmacist is recognized the possibility of becoming a strategic figure to meet the changed needs of the population on the one hand and the Italian National Health System on the other and to support the latter in the transition from a waiting medicine to an initiative medicine. Diabetic disease and the resulting chronic complications, today, have a very significant impact on patients and their families, on morbidity and mortality, as well as having a strong economic impact on the health system. Despite this, most of the patients do not carry out what is foreseen by their diagnostic therapeutic assistance path (PDTA) due to several reasons such as long waiting times, the need to move to undergo examinations, which is not so easy for young people of working age as well as older people, lack of homogeneity in access to care and in the provision of services and more. The community pharmacist, therefore, represents, for the position in which it is located within the Italian National Health Service, a potential not yet considered. In fact, it could take on the role of case manager (a professional who manages one or more cases entrusted to him according to a pre-established path, such as PDTA, in a defined space-time context) of the patient suffering from type 2 diabetes mellitus due to the capillarity territory, to the hourly availability superior to any other territorial health structure, to the health skills in its possession and to what it can offer in terms of services within the so-called pharmacy of service. In this scenario, the pharmacist would not replace any of the other actors already present in the multidisciplinary care team but would integrate in the same and, moreover, being already an agreement with the Italian National Health Service, the conferral of this role would not cause a excessive increase in costs, such as that resulting from the hiring of new staff to achieve the same objectives.

Interventions

OTHERFollow up

like group descriptions

Sponsors

Federfarma Campania
CollaboratorOTHER
Federfarma Salerno
CollaboratorOTHER
Health Telematic Network
CollaboratorINDUSTRY
Biochemical Systems International S.p.A.
CollaboratorINDUSTRY
Next Sight srl
CollaboratorINDUSTRY
Farmacia La Regina s.r.l.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Criteria Inclusion: * age\> 18 years, * patients with type 2 diabetes mellitus diagnosis; * able to express consent to the study.

Exclusion criteria

\- Nobody

Design outcomes

Primary

MeasureTime frameDescription
Percent of Participants With Adherence to the PDTA12 monthsMeasure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of pharmacy of service.

Secondary

MeasureTime frameDescription
Waiting Time365 daysvariation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)
Levels of Arterial Pressure12 monthsvariation of arterial pressure (Systolic, Diastolic) (mmHg)
Levels of HbA1c12 monthsvariation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy
Levels of LDL-cholesterol12 monthsvariation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy
Economic Impact12 monthsEvaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the pharmacy of service (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)

Countries

Italy

Participant flow

Recruitment details

Enrollment took place in the first 15 days of the operating period (November 1, 2018 - October 31, 2019). The patients were enrolled at the only experimentation center represented by La Regina pharmacy, a community pharmacy in a small rural center in southern Italy.

Pre-assignment details

None of the enrolled patients were excluded from the ongoing trial. All patients completed the entire observation period.

Participants by arm

ArmCount
Group Study
Enrolled patients include people with reduced glucose tolerance, or impaired fasting blood sugar, or type 2 diabetes free of organ complications, or type 2 diabetes with chronic complications.
40
Total40

Baseline characteristics

CharacteristicGroup Study
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
23 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
Age, Continuous64.5 years
STANDARD_DEVIATION 9.52
Ethnicity (NIH/OMB)
Hispanic or Latino
40 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Region of Enrollment
Italy
40 participants
Sex: Female, Male
Female
20 Participants
Sex: Female, Male
Male
20 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 40
other
Total, other adverse events
0 / 40
serious
Total, serious adverse events
0 / 40

Outcome results

Primary

Percent of Participants With Adherence to the PDTA

Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of pharmacy of service.

Time frame: 12 months

ArmMeasureGroupValue (NUMBER)
Group StudyPercent of Participants With Adherence to the PDTAPercentage of adherence to PDTA - 3 months98 percentage of participants
Group StudyPercent of Participants With Adherence to the PDTAPercentage of adherence to PDTA - 6 months98 percentage of participants
Group StudyPercent of Participants With Adherence to the PDTAPercentage of adherence to PDTA - 12 months98 percentage of participants
Secondary

Economic Impact

Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the pharmacy of service (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Group StudyEconomic Impact210.25 euro/patient/yearStandard Deviation 80.25
Secondary

Levels of Arterial Pressure

variation of arterial pressure (Systolic, Diastolic) (mmHg)

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Group StudyLevels of Arterial PressureSystolic pressure variation-13 percentage of changeStandard Deviation 12
Group StudyLevels of Arterial PressureDiastolic pressure variation-9 percentage of changeStandard Deviation 16
Secondary

Levels of HbA1c

variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Group StudyLevels of HbA1c-4 percentage of changeStandard Deviation 16
Secondary

Levels of LDL-cholesterol

variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Group StudyLevels of LDL-cholesterol-10 percentage of variationStandard Deviation 27
Secondary

Waiting Time

variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)

Time frame: 365 days

ArmMeasureGroupValue (MEAN)Dispersion
Group StudyWaiting TimeElectrocardiogram waiting list117 daysStandard Deviation 57.5
Group StudyWaiting TimeFundus Oculi waiting list120 daysStandard Deviation 50

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026