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

Effectiveness of Pharmacotherapy Follow-up Care in Outpatients With Type 2 Diabetes Mellitus: Randomized Clinical Trial

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

Primary outcomes evaluated are: hospitalization (percentage of participants hospitalized), severe evolving complication - ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion (presence or absence).

Other parameter checked: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP), total cholesterol (TC), waist circumference (WC), body mass index (BMI) and mortality. The investigators follow up all patients for up to 12 months.

Study Overview

• Status: Completed
• Conditions: Pharmaceutical Services
• Intervention / Treatment: Other: Pharmacotherapy follow-up care

Detailed Description

Background. Few Brazilian randomized controlled trials have established the benefits of pharmacotherapy follow-up in care of outpatients with type 2 diabetes mellitus in low-middle income country. This study evaluate the effectiveness of pharmacotherapy follow-up care to get better outcomes in outpatients with type 2 diabetes mellitus attended in the public health service in Brazil.

Method: In this single blind, placebo-controlled trial, the investigators random patients with type 2 diabetes mellitus into two groups: 1) pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and 2) control (n=30, attended by the usual procedure of dispensing).

Primary outcomes checked are: percentage of hospitalization, severe evolving complication (ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy and evolving foot lesion).

The investigators also check: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP), total cholesterol (TC), HbA1c/BP, HbA1c/TC, waist circumference (WC), body mass index (BMI) and mortality. The participants are followed up to 12 months.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sorocaba, São Paulo, Brazil, 18013004
      • Vital Brazil Community Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; 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; 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.; Other Names: Pharmacotherapy Workup
Other: Control; 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; 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.; Other Names: Pharmacotherapy Workup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalization	percentage of participants hospitalized due to diabetes	in 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severe evolving complication (ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion)	number of participants with complication	in 12 months

Collaborators and Investigators

• Sponsor: University of Sorocaba
• Collaborators: Cristiane de Cássia Bergamaschi
• Investigators: Principal Investigator: Cristiane de Cássia Bergamaschi, University of Sorocaba

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 23, 2016
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 29, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Cristiane

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not applied