Effectiveness of Pharmacotherapy Follow-up Care in Outpatients With Type 2 Diabetes Mellitus
NCT ID: NCT03196336
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-03-31
2017-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Cristiane de Cássia Bergamaschi
UNKNOWN
University of Sorocaba
OTHER
Responsible Party
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Luciane Cruz Lopes
PhD
Principal Investigators
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Cristiane de Cássia Bergamaschi
Role: PRINCIPAL_INVESTIGATOR
University of Sorocaba
Locations
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Vital Brazil Community Pharmacy
Sorocaba, São Paulo, Brazil
Countries
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Other Identifiers
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Cristiane
Identifier Type: -
Identifier Source: org_study_id
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