Effectiveness of Pharmacotherapy Follow-up Care in Outpatients With Type 2 Diabetes Mellitus: Randomized Clinical Trial
| Registry | NCT03196336 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, health services research |
| Enrollment | 60 (Actual) |
| Sponsor | University of Sorocaba (Other); collaborators: Cristiane de Cássia Bergamaschi |
| Conditions | Pharmaceutical Services |
| Interventions | Pharmacotherapy follow-up care (Other) |
| Dates | start 2015-03-01, primary completion 2017-12-01, completion 2017-12-01, first posted 2017-06-22, last updated 2020-03-31 |
| Locations | 1 site in Brazil |
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All trials for Pharmaceutical Services All trials of Pharmacotherapy follow-up care
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention | Other | Other: Pharmacotherapy follow-up care | 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. |
| Control | Other | Other: Pharmacotherapy follow-up care | 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. |
Sex: All, ages: 18 Years to 80 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Vital Brazil Community Pharmacy | Sorocaba, São Paulo | Brazil |