Effectiveness of Pharmacotherapy Follow-up Care in Outpatients With Type 2 Diabetes Mellitus

NCT03196336 | Completed

• 1 other identifier: Cristiane
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Pharmacotherapy follow-up can improve clinical outcomes of outpatients with type 2 diabetes mellitus. Methods: In this single blind, placebo-controlled trial, the participants with type 2 diabetes mellitus are randomized into two groups:

1. 1.pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and
2. 2.control (n=30, attended by the usual procedure of dispensing).

Conditions

Pharmaceutical Services

Outcome Measures

Primary Outcomes (1)

• hospitalization

  percentage of participants hospitalized due to diabetes

  in 12 months

Secondary Outcomes (1)

• severe evolving complication (ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion)

  in 12 months

Study Arms (2)

Intervention

OTHER

The intervention is the pharmacotherapeutic follow-up care. This service is performed according to the Pharmacotherapy Workup method, which is a protocol for the pharmacotherapeutic follow-up. This service identify, prevent and solve drug-related problems. It consiste of five pharmaceutical consultations (every up to 2-3 months) with the patient.

Other: Pharmacotherapy follow-up care

Control

OTHER

The intervention is the usual procedure of dispensation of drugs. It is performed in five meetings (every up to 2-3 months) between the investigator and the patient.

Other: Pharmacotherapy follow-up care

Interventions

Pharmacotherapy follow-up care OTHER

The pharmacotherapy follow-up care consists of five pharmaceutical consultations (every up to 2-3 months) aimed to identify, prevent and solve the drug related problems regarding the indication, effectiveness and safety of the use of medicines.

Also known as: Pharmacotherapy Workup

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with previous diagnosis of type 2 diabetes, HbA1c greater than 7% and age greater than 18 years

You may not qualify if:

• Types of diabetes other than type 2 diabetes; patients not responsible for administering their drugs and patients with mental deficits that could no understand the study.

Sponsors & Collaborators

• University of Sorocaba: lead
• Cristiane de Cássia Bergamaschi: collaborator

Study Sites (1)

Vital Brazil Community Pharmacy

Sorocaba, São Paulo, 18013004, Brazil

Location

Study Officials

• Cristiane de Cássia Bergamaschi

  University of Sorocaba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Pharmacotherapeutic follow-up care known as Pharmacotherapy Workup.

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: June 22, 2017
• Study Start: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)