NCT03752567

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

November 9, 2018

Results QC Date

January 2, 2020

Last Update Submit

February 1, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

adherenceterapyfollow upcommunity pharmacypharmacistcase managertelemedicinepharmacy of servicefundus cameraecglocal pharmacistgeneral physician

Outcome Measures

Primary Outcomes (1)

  • 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".

    12 months

Secondary Outcomes (5)

  • Waiting Time

    365 days

  • Levels of Arterial Pressure

    12 months

  • Levels of HbA1c

    12 months

  • Levels of LDL-cholesterol

    12 months

  • Economic Impact

    12 months

Study Arms (1)

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).

Other: Follow up

Interventions

Follow upOTHER

like group descriptions

Group study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with type 2 diabetes mellitus

You may qualify if:

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

You may not qualify if:

  • \- Nobody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farmacia La Regina dott. Rocco Vito

San Rufo, Salerno, 84030, Italy

Location

Related Publications (11)

  • 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.

    PMID: 23088168BACKGROUND

  • Brophy 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.

    PMID: 24773329BACKGROUND

  • Davidson 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.

    PMID: 18220688BACKGROUND

  • Wubben 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.

    PMID: 18363526BACKGROUND

  • Zullig 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.

    PMID: 24303930BACKGROUND

  • Maxwell 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.

    PMID: 26877253BACKGROUND

  • Littauer 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.

    PMID: 29317927BACKGROUND

  • Barr 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.

    PMID: 20698917BACKGROUND

  • Hughes 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.

    PMID: 29354547BACKGROUND

  • Nye 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.

    PMID: 28576957BACKGROUND

  • Emilia Romagna region. Causes of non-adherence to the diagnostic-therapeutic treatment of diabetes mellitus: a qualitative-quantitative study for improvement - Final report. June 2018

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

The monocentric nature of the study and the small number of patients, however statistically adequate, they represent limits, which can be overcome with the replication of the study on more than one wide scale.

Results Point of Contact

Title
Dr. Raffaele La Regina
Organization
Farmacia La Regina
raffaele.laregina@gmail.com
+393389066138

Study Officials

  • Raffaele La Regina, dr

    Farmacia La Regina s.r.l.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Community pharmacist

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 26, 2018

Study Start

November 1, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

February 12, 2020

Results First Posted

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

The data will be shared only in aggregate and anonymous form.

Locations

IT(1)