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Completed

NCT Number: NCT03196336

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

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.

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Key information

Conditions

Pharmaceutical Services

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vital Brazil Community Pharmacy

Sorocaba, São Paulo, 18013004, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Pharmacotherapy Workup

Primary outcomes

  1. hospitalization

    Time frame: in 12 months

    percentage of participants hospitalized due to diabetes

Secondary outcomes

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

    Time frame: in 12 months

    number of participants with complication

Sponsors and collaborators

Lead sponsor

University of Sorocaba

Other

Collaborators

  • Cristiane de Cássia Bergamaschi

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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