Diabetes Mellitus, Type 2NCT03752567
New Patient Support Program in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Farmacia La Regina s.r.l. at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Follow up
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 31 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with type 2 diabetes mellitus
Who may be able to join
None listed.
Who cannot join
- Nobody
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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
Non-profit observational study on the role of the community pharmacist and the "pharmacy of services" in the case management of the diabetic patient
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Follow up
- Keywords
- adherence, terapy, follow up, community pharmacy, pharmacist, case manager, telemedicine, pharmacy of service, fundus camera, ecg, local pharmacist, general physician
- 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.
Follow upOther
like group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Group study | Follow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria). Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 12 months
Secondary outcomes (5)
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)
Measured: 365 days
Levels of Arterial Pressure
variation of arterial pressure (Systolic, Diastolic) (mmHg)
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Nov 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farmacia La Regina s.r.l.
- Sponsor type
- University, hospital or other
- Collaborators
- Federfarma Campania, Federfarma Salerno, Health Telematic Network, Biochemical Systems International S.p.A., Next Sight srl
- Responsible party
- Principal investigator, Raffaele La Regina, Farmacia La Regina s.r.l.
- Investigators
- Raffaele La Regina, dr, Principal investigator, Farmacia La Regina s.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752567
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2020
- First submitted
- 9 Nov 2018
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared only in aggregate and anonymous form.
Publications
Gerber BS, Rapacki L, Castillo A, Tilton J, Touchette DR, Mihailescu D, Berbaum ML, Sharp LK. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health. 2012 Oct 23;12:891. doi: 10.1186/1471-2458-12-891.
PubMed 23088168Brophy L, Williams A, Berman EJ, Keleti D, Michael KE, Shepherd M, Fox SA, Jacobs C, Tan-Torres S, Gelzer AD, Tegenu M. Collaborative DTM reduces hospitalization and healthcare costs in patients with diabetes treated with polypharmacy. Am J Manag Care. 2014 Mar 1;20(3):e72-81.
PubMed 24773329Davidson MB. The effectiveness of nurse- and pharmacist-directed care in diabetes disease management: a narrative review. Curr Diabetes Rev. 2007 Nov;3(4):280-6. doi: 10.2174/157339907782330058.
PubMed 18220688Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421.
PubMed 18363526Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction. Telemed J E Health. 2014 Feb;20(2):135-43. doi: 10.1089/tmj.2013.0145. Epub 2013 Dec 4.
PubMed 24303930Maxwell LG, McFarland MS, Baker JW, Cassidy RF. Evaluation of the Impact of a Pharmacist-Led Telehealth Clinic on Diabetes-Related Goals of Therapy in a Veteran Population. Pharmacotherapy. 2016 Mar;36(3):348-56. doi: 10.1002/phar.1719. Epub 2016 Mar 11.
PubMed 26877253Littauer SL, Dixon DL, Mishra VK, Sisson EM, Salgado TM. Pharmacists providing care in the outpatient setting through telemedicine models: a narrative review. Pharm Pract (Granada). 2017 Oct-Dec;15(4):1134. doi: 10.18549/PharmPract.2017.04.1134. Epub 2017 Dec 19.
PubMed 29317927Barr PJ, McElnay JC, Hughes CM. Connected health care: the future of health care and the role of the pharmacist. J Eval Clin Pract. 2012 Feb;18(1):56-62. doi: 10.1111/j.1365-2753.2010.01522.x. Epub 2010 Aug 4.
PubMed 20698917Hughes JD, Wibowo Y, Sunderland B, Hoti K. The role of the pharmacist in the management of type 2 diabetes: current insights and future directions. Integr Pharm Res Pract. 2017 Jan 16;6:15-27. doi: 10.2147/IPRP.S103783. eCollection 2017.
PubMed 29354547Nye AM. A Clinical Pharmacist in Telehealth Team Care for Rural Patients with Diabetes. N C Med J. 2017 May-Jun;78(3):183-184. doi: 10.18043/ncm.78.3.183. No abstract available.
PubMed 28576957Emilia Romagna region. Causes of non-adherence to the diagnostic-therapeutic treatment of diabetes mellitus: a qualitative-quantitative study for improvement - Final report. June 2018
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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
- ClinicalTrials.gov ID
- NCT03752567
- Acronym / sponsor ID
- 1
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- adherence, terapy, follow up, community pharmacy, pharmacist, case manager, telemedicine, pharmacy of service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Farmacia La Regina s.r.l.University, hospital or other
- Collaborators
- Federfarma Campania, Federfarma Salerno, Health Telematic Network, Biochemical Systems International S.p.A., Next Sight srl
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group study | – | Other: Follow upFollow up of the patients for 12 months by the community pharmacist in the role of case manager and execution of the activities foreseen by the PAI (individual assistance plan) through telemedicine (ecg, fundus oculi, ankle arm index) and self analysis (glycated hemoglobin, lipid profile, uric acid microalbuminuria). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Nobody
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 |
|---|---|---|
| Follow uplike group descriptions | Other | Group study |
Primary outcome
Percent of Participants With Adherence to the PDTA
Time frame: 12 months
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".
5 secondary outcomes
Waiting Time
Time frame: 365 days
Levels of Arterial Pressure
Time frame: 12 months
Levels of HbA1c
Time frame: 12 months
Levels of LDL-cholesterol
Time frame: 12 months
Economic Impact
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23088168Gerber BS, Rapacki L, Castillo A, Tilton J, Touchette DR, Mihailescu D, Berbaum ML, Sharp LK. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health. 2012 Oct 23;12:891. doi: 10.1186/1471-2458-12-891.
- Background: PubMed 24773329Brophy L, Williams A, Berman EJ, Keleti D, Michael KE, Shepherd M, Fox SA, Jacobs C, Tan-Torres S, Gelzer AD, Tegenu M. Collaborative DTM reduces hospitalization and healthcare costs in patients with diabetes treated with polypharmacy. Am J Manag Care. 2014 Mar 1;20(3):e72-81.
- Background: PubMed 18220688Davidson MB. The effectiveness of nurse- and pharmacist-directed care in diabetes disease management: a narrative review. Curr Diabetes Rev. 2007 Nov;3(4):280-6. doi: 10.2174/157339907782330058.
- Background: PubMed 18363526Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421.
- Background: PubMed 24303930Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction. Telemed J E Health. 2014 Feb;20(2):135-43. doi: 10.1089/tmj.2013.0145. Epub 2013 Dec 4.
- Background: PubMed 26877253Maxwell LG, McFarland MS, Baker JW, Cassidy RF. Evaluation of the Impact of a Pharmacist-Led Telehealth Clinic on Diabetes-Related Goals of Therapy in a Veteran Population. Pharmacotherapy. 2016 Mar;36(3):348-56. doi: 10.1002/phar.1719. Epub 2016 Mar 11.
- Background: PubMed 29317927Littauer SL, Dixon DL, Mishra VK, Sisson EM, Salgado TM. Pharmacists providing care in the outpatient setting through telemedicine models: a narrative review. Pharm Pract (Granada). 2017 Oct-Dec;15(4):1134. doi: 10.18549/PharmPract.2017.04.1134. Epub 2017 Dec 19.
- Background: PubMed 20698917Barr PJ, McElnay JC, Hughes CM. Connected health care: the future of health care and the role of the pharmacist. J Eval Clin Pract. 2012 Feb;18(1):56-62. doi: 10.1111/j.1365-2753.2010.01522.x. Epub 2010 Aug 4.
- Background: PubMed 29354547Hughes JD, Wibowo Y, Sunderland B, Hoti K. The role of the pharmacist in the management of type 2 diabetes: current insights and future directions. Integr Pharm Res Pract. 2017 Jan 16;6:15-27. doi: 10.2147/IPRP.S103783. eCollection 2017.
- Background: PubMed 28576957Nye AM. A Clinical Pharmacist in Telehealth Team Care for Rural Patients with Diabetes. N C Med J. 2017 May-Jun;78(3):183-184. doi: 10.18043/ncm.78.3.183. No abstract available.
- BackgroundEmilia Romagna region. Causes of non-adherence to the diagnostic-therapeutic treatment of diabetes mellitus: a qualitative-quantitative study for improvement - Final report. June 2018
- Individual participant dataSharing planned: No. The data will be shared only in aggregate and anonymous form.
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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.
Raffaele La Regina, dr principal investigator
Farmacia La Regina s.r.l.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Farmacia La Regina s.r.l. at 1 site in Italy.
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 0 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 12 Feb 2020. 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 Italy. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Participants With Adherence to the PDTA (time frame: 12 months). 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 NCT03752567, which also lists 11 linked publications.
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 12 Feb 2020.